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Köhlmoos A, Dittmar M. Glycemic Variability and Control by CGM in Healthy Older and Young Adults and Their Relationship With Diet. J Endocr Soc 2025; 9:bvaf081. [PMID: 40401234 PMCID: PMC12089644 DOI: 10.1210/jendso/bvaf081] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/15/2024] [Indexed: 05/28/2025] Open
Abstract
Continuous glucose monitoring (CGM) might be beneficial for investigating healthy aging since high glycemic variability may increase protein glycation, oxidative stress, and inflammation, resulting in vascular damage. Additionally, CGM data on the risks for hypoglycemia and hyperglycemia are scarce, have not been analyzed by individual day and night blocks, and have not been related to diet. Therefore, this study aimed to compare glucose parameters of healthy older and young adults and the relationship with diet. Participants were 34 young (age 20-35 years) and 27 older volunteers (age 60-75 years) with a normal glycated hemoglobin A1c less than 39 mmol/mol hemoglobin, free of disorders and medication. Twenty-four CGM-derived glucose parameters measured over 5 consecutive days were analyzed for whole days and for individual daytime and nighttime blocks. Dietary intake was determined by 3-day dietary record. Neither intraday nor interday glycemic variability differed between the healthy age groups. Glycemic control was good in both age groups, but somewhat poorer in older adults. The risk of hyperglycemia was higher and of hypoglycemia lower in older adults. During the daytime, mean and minimum glucose were higher in older adults. During the nighttime, age group differences were small. The carbohydrate intake correlated positively with glycemic variability in both age groups. The protein intake correlated positively with the hypoglycemic risk in young adults, but negatively in older adults. Results suggest that healthy aging does not increase glycemic variability and the risk of hypoglycemia. The effect of diet on hypoglycemic and hyperglycemic risk might change with aging.
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Affiliation(s)
- Anika Köhlmoos
- Human Biology, Zoological Institute, Christian-Albrechts-University, Kiel 24118, Germany
| | - Manuela Dittmar
- Human Biology, Zoological Institute, Christian-Albrechts-University, Kiel 24118, Germany
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Zhu X, Gayathri R, Manasa VS, Abirami K, Bhupathiraju SN, Anjana RM, Givens DI, Wijeyesekera A, Sudha V, Mohan V, Vimaleswaran KS. Effects of lacto-vegetarian and vegan diets on glycemic responses and metabolite profiles in healthy adults: A randomized trial using continuous glucose monitoring and targeted metabolomics. Clin Nutr 2025; 49:138-148. [PMID: 40300220 DOI: 10.1016/j.clnu.2025.04.018] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/30/2024] [Revised: 03/15/2025] [Accepted: 04/12/2025] [Indexed: 05/01/2025]
Abstract
BACKGROUND Our previous studies have demonstrated that dairy products protect against type 2 diabetes (T2D) and improve cardiometabolic health outcomes. Given that continuous glucose monitoring (CGM) and metabolomics analysis capture different aspects of T2D, this study investigated the effects of dairy and non-dairy products on the glycemic and metabolite profiles in healthy adults following lacto-vegetarian and vegan diets. METHODS A parallel randomized feeding trial with 30 participants compared isoenergetic vegan and lacto-vegetarian diets. All participants wore CGM sensors for 14 days to track glucose concentrations. Anthropometric and biochemical characteristics were also measured. In a subgroup of 13 individuals, fasting and postprandial blood samples were collected on days 1 and 15 for metabolomics analysis. RESULTS Our CGM data showed higher mean glucose concentrations in the vegan group over 14 days compared to the lacto-vegetarian group (p = 0.0399), after adjusting for age, sex, body mass index, and baseline glucose concentrations. Metabolomics analysis from day 1 to day 15 showed increased postprandial phenylalanine (Phe; p = 0.0189) in the vegan group, while the lacto-vegetarian group showed increased acetyl carnitine (C2; p = 0.00704) and decreased argininosuccinic acid (p = 0.0149). CONCLUSIONS Our pilot CGM data suggest a lacto-vegetarian diet may offer better glycemic control, potentially explained by our preliminary metabolomics findings. The increased Phe observed in the vegan group may be explained by a hypothetical mechanism in which higher glucose induces oxidative stress, whereas the increased C2 from dairy in the lacto-vegetarian group may protect against oxidative stress, contributing to lower glucose concentrations. However, larger, longer-term studies with more diverse populations, along with in vitro investigations into biomolecular mechanisms, are needed to confirm these findings.
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Affiliation(s)
- Xianyu Zhu
- Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences and Institute for Cardiovascular and Metabolic Research (ICMR), University of Reading, Reading, RG6 6DZ, UK
| | - Rajagopal Gayathri
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India
| | - Valangaiman Sriram Manasa
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India
| | - Kuzhanthaivelu Abirami
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India
| | - Shilpa N Bhupathiraju
- Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA 02115, USA; Department of Nutrition, Harvard T H Chan School of Public Health, Boston, MA 02115, USA
| | - Ranjit Mohan Anjana
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India; Department of Diabetology, Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Centre, Chennai 600086, India
| | - D Ian Givens
- Institute for Food, Nutrition, and Health (IFNH), University of Reading, Reading RG6 5EU, UK
| | - Anisha Wijeyesekera
- Food Microbial Sciences Unit, Department of Food and Nutritional Sciences, School of Chemistry, Food and Pharmacy, University of Reading, Reading RG6 6DZ, UK
| | - Vasudevan Sudha
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India
| | - Viswanathan Mohan
- Department of Foods, Nutrition and Dietetics Research, Madras Diabetes Research Foundation, Chennai 600086, India; Department of Diabetology, Madras Diabetes Research Foundation and Dr. Mohan's Diabetes Specialties Centre, Chennai 600086, India
| | - Karani S Vimaleswaran
- Hugh Sinclair Unit of Human Nutrition, Department of Food and Nutritional Sciences and Institute for Cardiovascular and Metabolic Research (ICMR), University of Reading, Reading, RG6 6DZ, UK; Institute for Food, Nutrition, and Health (IFNH), University of Reading, Reading RG6 5EU, UK.
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Lenters‐Westra E, Fokkert M, Kilpatrick ES, Schleicher E, Pilla S, English E, van Dijk P. Managing discordance between HbA 1c and glucose management indicator. Diabet Med 2025; 42:e70023. [PMID: 40123266 PMCID: PMC12080991 DOI: 10.1111/dme.70023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/16/2024] [Revised: 02/25/2025] [Accepted: 02/27/2025] [Indexed: 03/25/2025]
Abstract
AIMS The assessment of haemoglobin A1c (HbA1c) continues to play an essential role in diabetes care; however, major advances in new technologies widen the armament available to clinicians to further refine treatment for their patients. Whilst HbA1c remains a critical glycaemic marker, advances in technologies such as Continuous Glucose Monitoring (CGM) now offer real-time glucose monitoring, allowing a more instant assessment of glycaemic control. Discrepancies between laboratory-measured HbA1c and Glucose Management Indicator (GMI) values are a significant clinical issue. In this article, we present a checklist of potential sources of error for both GMI and HbA1c values and provide suggestions to mitigate these sources in order to continue to improve diabetes care. METHODS We identified key literature pertaining to GMI measurement, HbA1c measurement, and potential factors of discordance between the two. Using these sources, we explore the potential factors leading to discordance and how to mitigate these when found. RESULTS We have constructed a quick reference checklist covering the main sources of discordance between HbA1c and GMI, with accompanying narrative text for more detailed discussion. Discordance can arise due to various factors, including CGM accuracy, sensor calibration, red blood cell turnover and other physiological conditions. CONCLUSIONS GMI will likely continue to be used in the upcoming years by both persons with diabetes and their health care providers, and so it is important for users of CGM devices to be equipped with the knowledge to understand the potential causes of discordance between GMI and HbA1c values.
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Affiliation(s)
- Erna Lenters‐Westra
- Department of Clinical ChemistryIsalaZwollethe Netherlands
- European Reference Laboratory for Glycohemoglobinthe Netherlands
| | - Marion Fokkert
- Department of Clinical ChemistryIsalaZwollethe Netherlands
| | - Eric S. Kilpatrick
- Department of Clinical BiochemistryManchester Foundation TrustManchesterUK
| | - Erwin Schleicher
- Department for Diagnostic Laboratory Medicine, Institute for Clinical Chemistry and PathobiochemistryUniversity Hospital TuebingenTuebingenGermany
| | - Scott Pilla
- Division of General Internal Medicine, Department of MedicineJohns Hopkins University School of MedicineBaltimoreMarylandUSA
| | | | - Peter van Dijk
- Department of Internal Medicine, Diabetes CentreIsalaZwollethe Netherlands
- Department of EndocrinologyUniversity of Groningen, University Medical CenterGroningenthe Netherlands
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Uslu NG, Kızılay DÖ, Demir G, Altınok YA, Darcan Ş, Özen S, Gökşen D. Is Automated Insulin Delivery System Therapy Safe and Effective in Children Under Seven Years Old? J Clin Res Pediatr Endocrinol 2025; 17:153-160. [PMID: 39564967 PMCID: PMC12118325 DOI: 10.4274/jcrpe.galenos.2024.2024-11-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Accepted: 11/19/2024] [Indexed: 11/21/2024] Open
Abstract
Objective To evaluate the off-label use of the MiniMed™ 780G system in children under seven years old, as clinical outcomes in this age group are less well-established, despite the improvements in glycemic control seen with MiniMed™ 780G therapy. Methods Children under seven years old with type 1 diabetes using MiniMed™ 780G pump therapy were compared with children of similar age and gender using MiniMed™ 640G insulin pump therapy and multiple-dose insulin therapy with continuous glucose monitoring systems (CGMs). CGM metrics, total daily insulin (TDI) dose, and hemoglobin A1c (HbA1c) levels were evaluated retrospectively at baseline and at the 3rd, 6th, and 12th months. Results At the initiation of MiniMed™ 780G therapy, the mean age was 5.25±1.22 years (range: 2.8-6.8 years), and the mean TDI was 10.12±4.34 U/day (range: 4.5-17.0 U/day). The glucose management indicator and HbA1c remained lower in the MiniMed™ 780G group at the 3rd, 6th, and 12th months compared to baseline (p=0.009 and p<0.001, respectively). In the MiniMed™ 780G group, time above range (TAR) was significantly lower at the 3rd, 6th, and 12th months (p=0.018, p=0.017 and p=0.04, respectively) while time in range (TIR) was higher at the 3rd, and 12th months (p=0.026 and p=0.019, respectively) compared to other groups. The coefficient of variation (CV) of the sensor glucose and HbA1c were lower at the 12th month (p=0.008 and p=0.015, respectively) compared to both other groups. No instances of ketoacidosis or severe hypoglycemic events were observed in any of the children during the follow-up period. Conclusion The absence of significantly higher levels of hypoglycemia compared to other groups at any time point, along with a significant decrease in TAR across all time points, a significant increase in TIR at the 3rd and 12th months, and a significant decrease in HbA1c and CV suggests that the MiniMed™ 780G system is both safe and effective for children under seven years old.
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Affiliation(s)
- Nihal Gül Uslu
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Deniz Özalp Kızılay
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Günay Demir
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Yasemin Atik Altınok
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Şükran Darcan
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Samim Özen
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
| | - Damla Gökşen
- Ege University Faculty of Medicine Department of Pediatrics, Clinic of Pediatric Endocrinology, İzmir, Türkiye
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Kumru Akin B, Goksoy E. Evaluation of continuous glucose monitoring and nutritional status in glycogen storage diseases. J Pediatr Endocrinol Metab 2025; 38:458-464. [PMID: 40056050 DOI: 10.1515/jpem-2024-0597] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Accepted: 02/14/2025] [Indexed: 05/15/2025]
Abstract
OBJECTIVES The primary goal in managing glycogen storage disorders (GSD) is to implement dietary therapy through regular glucose monitoring while attempting to prevent complications. Self-monitoring of blood glucose is often insufficient for detecting asymptomatic hypoglycemia in patients. Therefore, Continuous glucose monitoring systems (CGMS) play a crucial role in identifying hypoglycemic episodes and providing detailed glucose profiles throughout the day. In this study, CGMS data, laboratory findings, and daily nutritional intake were examined in patients with GSDIa and GSDIII. The lack of similar studies in GSDIII patients in the literature highlights the need for further research in this field. METHODS The glucose profiles of 12 patients (7 GSDIa and 5 GSDIII) were analyzed over a 72 h period using CGMS. Nutritional intake, biochemical parameters, and growth parameters were also evaluated. RESULTS This study demonstrated that CGMS detected both hypoglycemia (<70 mg/dL) and hyperglycemia (>150 mg/dL) in GSD patients. Growth retardation was also observed in these patients. As complications of the disease, elevated levels of liver enzymes, cholesterol, triglycerides, and creatine kinase were identified, with fatty liver and hepatomegaly detected in all patients. The patients' nutritional intake is similar to the recommendations in disease-specific treatment guidelines. CONCLUSIONS The primary dietary treatment goal for GSD patients is to maintain normoglycemia. Patients may experience asymptomatic low glucose and/or asymptomatic hypoglycemic episodes during treatment. CGMS enables a more detailed monitoring of glucose profiles, which not only facilitates the precise adjustment of dietary therapy based on detailed results but also helps prevent complications associated with the disease.
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Affiliation(s)
- Burcu Kumru Akin
- Division of Nutrition and Diet, Gaziantep Cengiz Gokçek Maternity and Children's Hospital, Gaziantep, Türkiye
| | - Emine Goksoy
- Division of Pediatric Metabolism, Adnan Menderes University, Aydın, Türkiye
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Kitagawa H, Munekage M, Seo S, Hanazaki K. Artificial pancreas: the past and the future. J Artif Organs 2025:10.1007/s10047-025-01510-1. [PMID: 40415035 DOI: 10.1007/s10047-025-01510-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/25/2025] [Accepted: 05/05/2025] [Indexed: 05/27/2025]
Abstract
In glucose management using continuous insulin infusion, artificial pancreas systems prevent blood glucose fluctuations and severe hypoglycemia using insulin pumps and continuous glucose monitoring. Advances in both insulin pumps and continuous glucose monitoring have enabled the transition from sensor augmented pump therapy, where insulin delivery is manually adjusted, to hybrid closed-loop insulin pump therapy, which automatically adjusts basal insulin infusion. Furthermore, fully automated insulin delivery systems that adjust insulin based on variations due to meals and exercise are now possible. These systems have been primarily applied to patients with type 1 diabetes but are now expanding to all insulin-dependent patients. Wearable artificial pancreas systems measure glucose levels in subcutaneous tissue fluid, while bedside artificial pancreas systems measure glucose levels in venous blood, making them suitable for managing the highly variable blood glucose levels of perioperative and critically ill patients. Future developments are anticipated to integrate the benefits of both wearable and bedside systems.
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Affiliation(s)
- Hiroyuki Kitagawa
- Department of Surgery, Kochi Medical School, Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan.
| | - Masaya Munekage
- Department of Surgery, Kochi Medical School, Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
| | - Satoru Seo
- Department of Surgery, Kochi Medical School, Kohasu, Okocho, Nankoku, Kochi, 783-8505, Japan
| | - Kazuhiro Hanazaki
- Kochi Medical School Hospital, Kohasu, Okocho, Nankoku, Kochi, 7838505, Japan
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Plaitano EG, Stanger C. Joint effect of nicotine use and diabetes distress on glycemic control in young adults with type 1 diabetes. J Diabetes Complications 2025; 39:109083. [PMID: 40398346 DOI: 10.1016/j.jdiacomp.2025.109083] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2024] [Revised: 05/12/2025] [Accepted: 05/14/2025] [Indexed: 05/23/2025]
Abstract
Nicotine inhibits glucose metabolism. In this national cross-sectional analysis of 388 young adults with type 1 diabetes and above target glycemic control, vaping was the most common route of nicotine use, and heavy nicotine use plus higher type 1 diabetes distress was related to worse objective measures of glycemic control. Trial registration: ClinicalTrials.govNCT04646473; https://clinicaltrials.gov/ct2/show/NCT04646473.
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Affiliation(s)
- Enzo G Plaitano
- Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH 03766, United States; The Dartmouth Institute for Health Policy and Clinical Practice, Geisel School of Medicine, Dartmouth College, Hanover, NH 03766, United States.
| | - Catherine Stanger
- Center for Technology and Behavioral Health, Geisel School of Medicine, Dartmouth College, Lebanon, NH 03766, United States.
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Cichosz SL, Kronborg T, Hangaard S, Vestergaard P, Jensen MH. Assessing the Accuracy of Continuous Glucose Monitoring Metrics: The Role of Missing Data and Imputation Strategies. Diabetes Technol Ther 2025. [PMID: 40364785 DOI: 10.1089/dia.2025.0102] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/15/2025]
Abstract
Aim: This study aims to evaluate the accuracy of continuous glucose monitoring (CGM)-derived metrics, particularly those related to glycemic variability, in the presence of missing data. It systematically examines the effects of different missing data patterns and imputation strategies on both standard glycemic metrics and complex variability metrics. Methods: The analysis modeled and compared the effects of three types of missing data patterns-missing completely at random, segmental, and block-wise gaps-with proportions ranging from 5% to 50% on CGM metrics derived from 14-day profiles of individuals with type 1 and type 2 diabetes. Six imputation strategies were assessed: data removal, linear interpolation, mean imputation, piecewise cubic Hermite interpolation, temporal alignment imputation, and random forest-based imputation. Results: A total of 933 14-day CGM profiles from 468 individuals with diabetes were analyzed. Across all metrics, the coefficient of determination (R2) improved as the proportion of missing data decreased, regardless of the missing data pattern. The impact of missing data on the agreement between imputed and reference metrics varied depending on the missing data pattern. To achieve high accuracy (R2 > 0.95) in representing true metrics, at least 70% of the CGM data were required. While no imputation strategy fully compensated for high levels of missing data, simple removal outperformed others in most scenarios. Conclusion: This study examines the impact of missing data and imputation strategies on CGM-derived metrics. The findings suggest that while missing data may have varying effects depending on the metric and imputation method, removing periods without data is a general acceptable approach.
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Affiliation(s)
- Simon Lebech Cichosz
- Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
| | - Thomas Kronborg
- Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
- Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark
| | - Stine Hangaard
- Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
- Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark
| | - Peter Vestergaard
- Steno Diabetes Center North Denmark, Aalborg University Hospital, Aalborg, Denmark
- Department of Endocrinology, Aalborg University Hospital, Aalborg, Denmark
| | - Morten Hasselstrøm Jensen
- Department of Health Science and Technology, Aalborg University, Aalborg, Denmark
- Data Science, Novo Nordisk, Søborg, Denmark
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Calliari LE, Contreras Sepúlveda Á, Coronel-Restrepo N, Kabakian L, Lamounier RN, Picasso E, Proietti A, Ramírez-Rincón A, Yépez-Rodriguez AE. How to take action beyond ambulatory glucose profile: Latin American expert recommendations on CGM data interpretation. Diabetol Metab Syndr 2025; 17:149. [PMID: 40340929 PMCID: PMC12060294 DOI: 10.1186/s13098-025-01702-y] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/22/2025] [Accepted: 04/12/2025] [Indexed: 05/10/2025] Open
Abstract
PURPOSE This expert consensus provides a standardized methodology for interpreting continuous glucose monitoring (CGM) data to optimize diabetes management. It aims to help healthcare professionals recognize glycemic patterns and apply targeted interventions based on real-time glucose metrics. METHODS A systematic literature review informed expert panel discussions. Specialists from Latin America assessed CGM interpretation challenges, reviewed key metrics, and reached consensus through an anonymous voting process. The recommendations align with international guidelines while addressing regional limitations in technology access and healthcare infrastructure. RESULTS Reliable CGM data interpretation requires at least 70% sensor use over 14 days. The Ambulatory Glucose Profile (AGP) report serves as the primary tool, offering essential metrics such as time in range (TIR), time below range (TBR), time above range (TAR), coefficient of variation (CV), and glucose management indicator (GMI). Identifying hyperglycemia, hypoglycemia, and glucose variability allows for personalized treatment adjustments. The panel adopted international glycemic targets, adapting them to Latin American settings. The time in tight range (TITR) was considered but not included due to limited supporting evidence and regional barriers to advanced CGM technology. CONCLUSIONS Standardized CGM interpretation improves glycemic control and treatment decisions. These recommendations provide a structured approach to diabetes care, aiming to enhance clinical outcomes and address healthcare disparities in Latin America.
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Affiliation(s)
| | | | | | | | - Rodrigo N Lamounier
- Internal Medicine Department, School of Medicine, Federal University of Minas Gerais (UFMG), Belo Horizonte, Brazil
| | - Emma Picasso
- Pediatric Endocrinology Department, Clínica EnDi y Corporativo Hospital Satélite (CHS), Ciudad de Mexico, México
| | - Adrian Proietti
- Endocrinology and Diabetes Department, Kynet Integral, Buenos Aires, Argentina
| | - Alex Ramírez-Rincón
- Scientific Direction, IPS Especializada Diabetes SURA, Clínica Auna Las Américas, Universidad Pontificia Bolivariana, Medellín, Colombia
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Jávorfi T, Kocsis G, Svébis MM, Ferencz V, Domján BA, Kézdi Á, Hankó H, Putz Z, Tabák ÁG. Glucose management indicator: Do we need device-specific equations? DIABETES & METABOLISM 2025; 51:101661. [PMID: 40339739 DOI: 10.1016/j.diabet.2025.101661] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 03/22/2025] [Revised: 04/14/2025] [Accepted: 04/18/2025] [Indexed: 05/10/2025]
Abstract
AIM Glucose management indicator (GMI) may not perform equally well for different continuous glucose monitoring (CGM) systems. Thus, we aimed to develop device-specific GMI for the Guardian 3 and 4 sensors, compare them to the original GMI, and investigate the association between the glycaemic gap (=HbA1c-GMI) and HbA1c. METHODS In a single-centre, observational study of adult type 1 diabetes patients using Guardian Sensor 3 (G3) and 4 (G4) CGM devices, we estimated HbA1c using CGM-derived mean glucose for both CGMs using linear mixed models. We compared the estimates and their residuals (G3-gap and G4-gap) to the original GMI and its residuals (Bergenstal-gap) using regression and Bland-Altman plots. RESULTS We included 120 adult type 1 diabetes patients (90 with G3 and 30 with G4) and 194 measurement points. We found that for G3 and G4 sensors, GMI significantly underestimated glycaemia in high HbA1c ranges, reaching the clinically significant 0.5 %[4.4 mmol/mol] difference at 7.6 % [60 mmol/mol] for G3 and 8.3 % [67 mmol/mol] for G4 sensors. For G4, GMI significantly overestimated glycaemia in the lower HbA1c range. We found a strong relationship between all 3 gaps and HbA1c, and the slope was steeper for the Bergenstal-gap versus the sensor-specific G3 and G4 gaps. The G3-gap was approximately half as large as the Bergenstal-gap for HbA1c > 7 % [53 mmol/mol], and the G4-gap is approximately half of the Bergenstal-gap for the whole HbA1c range. CONCLUSION Device-specific GMI equations could reduce the risk of clinically significant under- and overestimation of HbA1c, improving clinical decision-making.
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Affiliation(s)
- Tamás Jávorfi
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary; Károly Rácz Conservative Medicine Division, Doctoral College, Semmelweis University, Budapest, Hungary.
| | - Győző Kocsis
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary
| | - Márk M Svébis
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary; Károly Rácz Conservative Medicine Division, Doctoral College, Semmelweis University, Budapest, Hungary
| | - Viktória Ferencz
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary
| | - Beatrix A Domján
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary; Károly Rácz Conservative Medicine Division, Doctoral College, Semmelweis University, Budapest, Hungary
| | - Árpád Kézdi
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary; Károly Rácz Conservative Medicine Division, Doctoral College, Semmelweis University, Budapest, Hungary
| | - Hanna Hankó
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary
| | - Zsuzsanna Putz
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary
| | - Ádám G Tabák
- Department of Internal Medicine and Oncology, Semmelweis University Faculty of Medicine, Budapest, Hungary; Institute of Preventive Medicine and Public Health, Semmelweis University Faculty of Medicine, Budapest, Hungary; UCL Brain Sciences, University College London, London, UK
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Goshrani A, Lin R, O'Neal D, Ekinci EI. Time in range-A new gold standard in type 2 diabetes research? Diabetes Obes Metab 2025; 27:2342-2362. [PMID: 40000405 PMCID: PMC11965008 DOI: 10.1111/dom.16279] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2024] [Revised: 01/27/2025] [Accepted: 02/04/2025] [Indexed: 02/27/2025]
Abstract
Glycated haemoglobin (HbA1c) is currently the gold standard outcome measure for type 2 diabetes trials. Time in range is a continuous glucose monitoring (CGM) metric defined as the proportion of time in euglycemia (3.9-10.0 mmol/L) and may be valuable not only in type 1 diabetes clinical trials but also as an endpoint in type 2 diabetes trials. This narrative review aimed to assess the relative merits of time in range versus HbA1c as outcome measures for type 2 diabetes studies. It reviews the strengths and limitations of time in range as an outcome measure and evaluates studies in type 2 diabetes that have used time in range as a primary or secondary outcome measure. A literature search was conducted on PubMed and MEDLINE databases using key terms "time in range" AND "diabetes" OR "type 2 diabetes mellitus". Further evidence was obtained from relevant references of retrieved articles. Literature search identified 247 papers, of which 110 were included in this review. These included a broad range of articles, including 45 randomized trials using time in range as an outcome measure in patients with type 2 diabetes, as well as papers validating time in range. Time in range provides valuable and clinically relevant information and should be used as an important endpoint in type 2 diabetes in clinical trial settings, in conjunction with HbA1c.
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Affiliation(s)
- Ashni Goshrani
- Department of EndocrinologyNorthern HealthMelbourneAustralia
| | - Rose Lin
- Department of EndocrinologyAustin HealthMelbourneAustralia
- Department of EndocrinologyBendigo HealthMelbourneAustralia
| | - David O'Neal
- The Australian Centre for Accelerating Diabetes Innovations, Melbourne Medical SchoolThe University of MelbourneMelbourneVictoriaAustralia
- Department of EndocrinologySt Vincents HospitalMelbourneAustralia
- Department of Medicine, Melbourne Medical SchoolThe University of MelbourneMelbourneVictoriaAustralia
| | - Elif I. Ekinci
- Department of EndocrinologyAustin HealthMelbourneAustralia
- The Australian Centre for Accelerating Diabetes Innovations, Melbourne Medical SchoolThe University of MelbourneMelbourneVictoriaAustralia
- Department of Medicine, Melbourne Medical SchoolThe University of MelbourneMelbourneVictoriaAustralia
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Kim JY, Kim S, Kim JH. Comparison of Real-Time and Intermittently-Scanned Continuous Glucose Monitoring for Glycemic Control in Type 1 Diabetes Mellitus: Nationwide Cohort Study. Diabetes Metab J 2025; 49:436-447. [PMID: 40012108 PMCID: PMC12086561 DOI: 10.4093/dmj.2024.0160] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/28/2024] [Accepted: 10/30/2024] [Indexed: 02/28/2025] Open
Abstract
BACKGRUOUND This study compares the association between real-time continuous glucose monitoring (rtCGM) and intermittently- scanned CGM (isCGM) and glycemic control in individuals with type 1 diabetes mellitus (T1DM) in a real-world setting. METHODS Using data from the Korean National Health Insurance Service Cohort, individuals with T1DM managed by intensive insulin therapy were followed at 3-month intervals for 2 years after the initiation of CGM. The glycosylated hemoglobin (HbA1c) levels and coefficients of variation (CVs) of rtCGM and isCGM users were compared using independent two-sample t-test and a linear mixed model. RESULTS The analyses considered 7,786 individuals (5,875 adults aged ≥19 years and 1,911 children and adolescents aged <19 years). Overall, a significant reduction in HbA1c level was observed after 3 months of CGM, and the effect was sustained for 2 years. The mean HbA1c level at baseline was higher in rtCGM users than in isCGM users (8.9%±2.7% vs. 8.6%±2.2%, P<0.001). However, from 3 to 24 months, rtCGM users had lower HbA1c levels than isCGM users at every time point (7.1%±1.2% vs. 7.5%±1.3% at 24 months, P<0.001 for all time points). In both adults and children, the greater reduction in HbA1c with rtCGM remained significant after adjusting for the baseline characteristics of the users. The CV also showed greater decrease with rtCGM than with isCGM. CONCLUSION In this large nationwide cohort study, the use of rtCGM was associated with a greater improvement in glycemic control, including HbA1c reduction, than the use of isCGM in both adults and children with T1DM.
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Affiliation(s)
- Ji Yoon Kim
- Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
| | - Seohyun Kim
- Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea
| | - Jae Hyeon Kim
- Division of Endocrinology and Metabolism, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
- Department of Clinical Research Design and Evaluation, Samsung Advanced Institute for Health Sciences & Technology, Sungkyunkwan University, Seoul, Korea
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Shah VN, Dex T, Meneghini L, Rodrigues A, Polonsky WH. Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes. Diabetes Obes Metab 2025; 27:2523-2530. [PMID: 39950217 PMCID: PMC11965002 DOI: 10.1111/dom.16251] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2024] [Revised: 01/22/2025] [Accepted: 01/30/2025] [Indexed: 04/04/2025]
Abstract
AIMS In Soli-CGM, treatment with iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL) in insulin-naive adults with suboptimally controlled type 2 diabetes (T2D; haemoglobin A1c 9%-13% on ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy) increased time in range (TIR; primary endpoint) from 26.4% at baseline to 52.7% at Week 16. This exploratory analysis examined the impact of treatment with iGlarLixi on patient-reported treatment satisfaction. MATERIALS AND METHODS Soli-CGM was a single-arm, 16-week, multicentre, interventional, open-label, phase 4 study using blinded continuous glucose monitoring (CGM; FreeStyle Libre Pro) to assess glycaemic metrics (N = 124). CGM data were collected for a 2-week period before initiation of iGlarLixi, and after treatment with iGlarLixi (Weeks 14-16). Treatment satisfaction was assessed using the Diabetes Medication Treatment Satisfaction Tool (DM-SAT, which comprises four domains: well-being, medical control, lifestyle and convenience), at baseline and end-of-treatment. Association of TIR and overall satisfaction (sum of all items) was also assessed. RESULTS Overall, 118 (95.9%) and 107 (87.0%) participants completed the DM-SAT at baseline and Week 16, respectively. Mean overall score increased by 0.18, from 0.59 (baseline) to 0.78 (Week 16). A trend in improvement in score was observed in all domains. Improvement in TIR had a positive, but weak, trend of association with improvement in overall treatment satisfaction (mean r = 0.14). CONCLUSIONS In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RA, 16 weeks' treatment with iGlarLixi resulted in a trend of improvement in treatment satisfaction.
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Affiliation(s)
- Viral N. Shah
- Indiana University School of MedicineIndianapolisIndianaUSA
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Hansen KW. How to compare algorithms for automated insulin delivery using different sensors? Diabetes Obes Metab 2025; 27:2319-2321. [PMID: 39910766 PMCID: PMC11965003 DOI: 10.1111/dom.16234] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/11/2024] [Revised: 01/14/2025] [Accepted: 01/24/2025] [Indexed: 02/07/2025]
Affiliation(s)
- Klavs Würgler Hansen
- Silkeborg Regional Hospital and Department of Clinical MedicineAarhus UniversityAarhusDenmark
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Fisker S, Christensen M, Bach E, Bibby BM, Hansen KW. Long-Term Performance of Two Systems for Automated Insulin Delivery in Adults With Type 1 Diabetes: An Observational Study. Endocrinol Diabetes Metab 2025; 8:e70043. [PMID: 40198839 PMCID: PMC11977919 DOI: 10.1002/edm2.70043] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/17/2025] [Revised: 02/27/2025] [Accepted: 03/03/2025] [Indexed: 04/10/2025] Open
Abstract
AIMS To compare glycaemic outcomes for two automated insulin delivery (AID) systems, the Tandem Control IQ (CIQ) and the MiniMed 780G (MM780G). MATERIAL AND METHODS In this observational study, we evaluated 60 days of glycaemic data from 139 persons with type 1 diabetes (CIQ: 79 persons, MM780G: 60 persons), who had an active glucose sensor time ≥ 85%. RESULTS The time with AID was median 620 (IQR, 439-755) days for CIQ users and 509 (429-744) days for MM780G users (p = 0.26). The last HbA1c before initiation of AID was 59.7 mmol/mol in CIQ and 60.1 mmol/mol in MM780G (p = 0.88). The time with an active glucose sensor was higher for CIQ than MM780G (median 98.5 (97.4-98.0)% vs. 96.5 (94.9-97.0)%, p < 0.001). Time in range (TIR, glucose 3.9-10.0 mmol/L) was lower in CIQ than MM780G (mean 68.9% ± 11.4% vs. 73.7% ± 12.0%, p = 0.02) as was time in tight range (TITR) (glucose 3.9-7.8 mmol/L) (43.0% ± 12.2% vs. 48.4% ± 12.7%, p = 0.01). The difference in TIR (4.2 (95% CI 1.0-7.5)%, p = 0.01) and TITR (5.0 (1.4-8.6)%, p < 0.01) remained statistically significant in a multiple regression model controlling for various baseline variables. Time with an absolute rate of glucose change > 1.5 mmol/L/15 min was higher in CIQ than MM780G (9.4 (IQR, 7.2-13.3)% vs. 7.4 (5.2-10.4)%, p < 0.001). CONCLUSIONS The CIQ system had a higher active glucose sensor time but a lower TIR, TITR, and a higher time with a rapid glucose rate of change than the MM780G system.
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Affiliation(s)
- Sanne Fisker
- Steno Diabetes Center AarhusAarhus University HospitalAarhusDenmark
| | - Mia Christensen
- Medical Diagnostic CenterSilkeborg Regional HospitalSilkeborgDenmark
| | - Ermina Bach
- Steno Diabetes Center AarhusAarhus University HospitalAarhusDenmark
- Medical Diagnostic CenterViborg Regional HospitalViborgDenmark
| | - Bo Martin Bibby
- Section for Biostatistics, Department of Public HealthAarhus UniversityAarhusDenmark
| | - Klavs Würgler Hansen
- Medical Diagnostic CenterSilkeborg Regional HospitalSilkeborgDenmark
- Department of Internal MedicineAarhus UniversityAarhusDenmark
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Niwaha AJ, Balungi PA, McDonald TJ, Hattersley AT, Shields BM, Nyirenda MJ, Jones AG. Glycated albumin and fructosamine do not improve accuracy of glycaemic control assessment in patients with conditions reported to affect HbA 1c reliability. Diabet Med 2025:e70011. [PMID: 40289332 DOI: 10.1111/dme.70011] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/25/2024] [Revised: 01/28/2025] [Accepted: 02/05/2025] [Indexed: 04/30/2025]
Abstract
AIMS HbA1c testing in African populations may be limited due to high prevalence of hemoglobinopathies, anaemia, malaria and renal impairment. We aimed to assess the performance of glycated albumin (GA) and fructosamine in comparison to HbA1c for determining glycaemic control in Africans living with type 2 diabetes. METHODS We compared the relationship between fructosamine, GA, and HbA1c with mean continuous glucose monitoring (CGM) glucose and assessed the impact of sickle cell trait (SCT), anaemia and renal impairment on the relationship between each measure and CGM glucose. RESULTS The overall association of HbA1c, GA and fructosamine with CGM glucose was similar (r = 0.88 [95%CI: 0.84, 0.91], 0.84 [0.79, 0.88] and 0.84 [0.79, 0.88]), respectively. For detecting those with mean CGM glucose >8 mmol/L HbA1c had similar diagnostic accuracy to GA and fructosamine, even in those with conditions reported to affect HbA1c performance (n = 63). We found no evidence that SCT (n = 43/192) altered the relationship between HbA1c, fructosamine or GA with CGM glucose (p > 0.3 for all). However, individuals with anaemia showed an underestimation of CGM glucose by HbA1c and fructosamine compared to those without anaemia (p for interaction <0.005 for both). In contrast, GA with average CGM glucose between those with anaemia and those without were not significantly different. CONCLUSIONS Switching to fructosamine or GA is unlikely to improve the accuracy of laboratory glycaemic monitoring beyond that of HbA1c in a population with high prevalence of conditions reported to affect HbA1c reliability.
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Affiliation(s)
- Anxious J Niwaha
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter Medical School, Exeter, UK
- Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, Entebbe, Uganda
| | - Priscilla A Balungi
- Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, Entebbe, Uganda
| | - Timothy J McDonald
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter Medical School, Exeter, UK
| | - Andrew T Hattersley
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter Medical School, Exeter, UK
| | - Beverley M Shields
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter Medical School, Exeter, UK
| | - Moffat J Nyirenda
- Medical Research Council/Uganda Virus Research Institute and LSHTM Uganda Research Unit, Entebbe, Uganda
- Department of Non-Communicable Diseases Epidemiology, London School of Hygiene and Tropical Medicine (LSHTM), London, UK
| | - Angus G Jones
- Institute of Biomedical and Clinical Science, College of Medicine and Health, University of Exeter Medical School, Exeter, UK
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Chen YE, Ku CW, Chong MF, Yap F, Chan JKY, Loy SL, Chen LW. Associations of >1-h compared with 1-h meal timing variability (eating jetlag) with plasma glycemic parameters and continuous glucose monitoring measures among pregnant females: a prospective cohort study. Am J Clin Nutr 2025:S0002-9165(25)00243-6. [PMID: 40294750 DOI: 10.1016/j.ajcnut.2025.04.026] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/04/2024] [Revised: 04/01/2025] [Accepted: 04/22/2025] [Indexed: 04/30/2025] Open
Abstract
BACKGROUND Eating jetlag (EJL), the difference in eating times between weekdays and weekends, disrupts circadian alignment and may affect metabolic health. However, its influence on glucose tolerance and continuous glucose monitoring (CGM) during pregnancy remains unknown. OBJECTIVES We aimed to investigate the associations between EJL and glycemic parameters during pregnancy. METHODS This secondary analysis was conducted on a cohort of 248 healthy pregnant females from Singapore. EJL, derived from 4-d food diaries at 20-wk of gestation, was the absolute difference in average meal times between weekdays and weekends for the first (EJLfirst) and last (EJLlast) meals and categorized as ≤1-h (reference) or >1-h. Primary outcomes at 25-wk of gestation included results from the 75-g oral glucose tolerance test, fasting insulin, homeostasis model assessment of insulin resistance (HOMA2-IR), and β-cell function (HOMA2-%B). Secondary outcomes at 20-wk of gestation included glycemic control and variability measured over 10-d using CGM. Skewed glycemic variables were log-transformed for normality, and associations between EJL and glycemic outcomes were analyzed using multivariable regressions. RESULTS After adjusting for baseline sociodemographic, lifestyle, and dietary factors, EJLlast >1-h was associated with higher fasting insulin [geometric mean ratio (95% confidence intervals): 1.21 (1.05, 1.39)], HOMA2-IR [1.21 (1.05, 1.39)], HOMA2-%B [1.11 (1.01, 1.22)], and CGM-based measures, including mean glucose [1.05 (1.00, 1.09)], J-index [1.11 (1.01, 1.22)], and glucose management indicator [1.03 (1.00, 1.06)]. EJLfirst >1-h was associated with higher CGM-based mean amplitude of glycemic excursions (MAGE) [1.09 (1.01, 1.19)]. For CGM-based glycemic variability outcomes (standard deviation, coefficient of variation [CV], MAGE), there were interactions between EJLfirst and 1) diet quality [adherence to Dietary Approaches to Stop Hypertension (DASH)] (P-interactions = 0.06-0.09), and 2) prepregnancy body mass index (BMI) (P-interaction=0.07 for CV). In females with a prepregnancy BMI ≥23 kg/m2 and low diet quality (DASH score ≤median), EJLfirst >1 h was associated with higher CGM-based glycemic variability. CONCLUSIONS EJL was associated with unfavorable glycemic parameters during pregnancy. Dietary interventions could promote consistent meal timing, especially in higher risk groups with suboptimal nutritional status. This trial was registered at clinicaltrials.gov as NCT03803345.
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Affiliation(s)
- Yu-En Chen
- Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan
| | - Chee Wai Ku
- Duke-NUS Medical School, Singapore, Singapore; Department of Reproductive Medicine, KK Women's and Children's Hospital, Singapore, Singapore
| | - Mary Ff Chong
- Saw Swee Hock School of Public Health, National University of Singapore, Singapore, Singapore
| | - Fabian Yap
- Duke-NUS Medical School, Singapore, Singapore; Endocrinology Service, KK Women's and Children's Hospital, Singapore, Singapore; Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore, Singapore
| | - Jerry Kok Yen Chan
- Duke-NUS Medical School, Singapore, Singapore; Department of Reproductive Medicine, KK Women's and Children's Hospital, Singapore, Singapore
| | - See Ling Loy
- Duke-NUS Medical School, Singapore, Singapore; Department of Reproductive Medicine, KK Women's and Children's Hospital, Singapore, Singapore
| | - Ling-Wei Chen
- Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan; Master of Public Health Program, College of Public Health, National Taiwan University, Taipei, Taiwan.
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Wang Y, Tang S, Liu H, Li Y. The relationship between hemoglobin glycation index and all-cause mortality in ill critically patients with heart failure: a retrospective study in MIMIC-IV database. BMC Cardiovasc Disord 2025; 25:317. [PMID: 40275131 PMCID: PMC12020299 DOI: 10.1186/s12872-025-04711-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/19/2025] [Accepted: 03/27/2025] [Indexed: 04/26/2025] Open
Abstract
BACKGROUND Heart failure (HF) is a major cause of mortality in critically ill patients and often requires intensive care. The hemoglobin glycation index (HGI), defined as the difference between predicted glycated hemoglobin (HbA1c) and measured HbA1c, may provide additional prognostic insights beyond traditional glycemic metrics. METHODS We conducted a retrospective analysis of 8,098 adult patients with HF from the MIMIC-IV database (2008-2022). All were first-time ICU admissions with available hematologic and metabolic data. Patients were stratified into three groups (T1 ≤ - 1.26, - 1.26 < T2 < 1.74, T3 ≥ 1.74) based on HGI. Baseline characteristics were recorded within 24 h of ICU admission, including demographic data, disease severity scores, comorbidities, and medication use. Logistic regression and Cox proportional hazards models assessed the associations between HGI and in-hospital, 30-day, and 1-year all-cause mortality, adjusting for age, sex, race, comorbidities, laboratory results, and relevant treatments. Restricted cubic spline (RCS) analysis was performed to examine potential non-linear relationships. We used sensitivity analyses to increase the confidence in our primary outcome. RESULTS Patients in the lowest HGI group (T1) had significantly higher in-hospital, 30-day, and 1-year mortality than those in the other two groups. Specifically, T1 showed an 18.6% in-hospital mortality rate, compared with 12.3% and 9.7% in T2 and T3, respectively (p < 0.001). Fully adjusted models revealed that each 1-unit increase in HGI was associated with an approximate 12% reduction in in-hospital mortality risk (OR = 0.88; 95%CI: 0.83-0.93), and an 3% decreased risk of 1-year all-cause mortality (HR 0.97; 95%CI0.94~1.00). RCS analysis indicated a J-shaped relationship between HGI and mortality, underscoring the heightened risk associated with very low HGI. We conducted sensitivity analyses by separately excluding missing data, diagnosed sepsis, and diagnosed hepatic impairment, consistent with the primary analysis. CONCLUSIONS In critically ill HF patients, extremely low HGI levels correlate with poorer short- and long-term survival. These findings suggest that HGI could serve as an adjunct risk stratification tool, prompting closer monitoring and potential intervention in patients with markedly low HGI.
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Affiliation(s)
- Yulong Wang
- Department of Cardiology, Tianjin Medical University General Hospital, Tianjin Medical University, 154, Anshan Road, Heping District, Tianjin, 300052, China
| | - Shanshan Tang
- Department of Cardiology, Tianjin Medical University General Hospital, Tianjin Medical University, 154, Anshan Road, Heping District, Tianjin, 300052, China
| | - Haokun Liu
- Department of Cardiology, Tianjin Medical University General Hospital, Tianjin Medical University, 154, Anshan Road, Heping District, Tianjin, 300052, China
| | - Yongle Li
- Department of Cardiology, Tianjin Medical University General Hospital, Tianjin Medical University, 154, Anshan Road, Heping District, Tianjin, 300052, China.
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Topalian N, Picard S, Riveline JP, Canha D, Julla JB, Lablanche S, Salle L, Sonnet E, Berot A, Gouet D, Bilariki K, Amouyal C, Marchand L, Borot S, Chevalier N, Banu I, Sokol E, Cosson E, Fagherazzi G, Aguayo G. Musculoskeletal disorders in type 1 diabetes: Clinical phenotyping and associations with quality of life and glucose control - The French SFDT1 cohort study. DIABETES & METABOLISM 2025; 51:101647. [PMID: 40280481 DOI: 10.1016/j.diabet.2025.101647] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 11/18/2024] [Revised: 03/31/2025] [Accepted: 04/04/2025] [Indexed: 04/29/2025]
Abstract
BACKGROUND Musculoskeletal disorders (MSDs) are common, but overlooked, complications of type 1 diabetes mellitus (T1DM). This study aims to describe MSD phenotypes (clinical, lifestyle, socio-economic) in adults with T1DM. METHODS We analyzed adult participants in the SFDT1 cohort study. We assessed the following MSDs: stress fractures, non-traumatic upper-limb disorders, and entrapment syndromes. We performed a cross-sectional analysis of the association between MSDs and various factors. After applying multiple imputations for missing data, we computed logistic regression models with progressive adjustments on confounding factors. RESULTS Of 1832 participants (53 % men, median age 38 (IQR 22) years), 34 % reported at least one personal history of MSD: 8 % for stress fractures, 24 % for upper-limb disorders and 15 % for entrapment syndromes. A higher prevalence of MSDs was found in women, with aging and with diabetes duration. In a fully adjusted model, we observed a positive association between current smoking (OR [95 %CI] = 1.50 [1.14;1.97]), non-excessive alcohol consumption (1.45 [1.14;1.85]), neuropathy (1.70 [1.35;2.15]), retinopathy (1.30 [1.02;1.65]), use of automated insulin delivery systems (1.53 [1.06;2.21]) and MSDs. MSDs were associated with reduced global quality of life (0.97 [0.95;0.98]). MSDs were not associated with HbA1c, social vulnerability or physical activity. CONCLUSION We have shown that MSDs are found in 1 in 3 people with T1DM. They are associated with several lifestyle factors, diabetes complications and the use of automated insulin delivery systems. MSDs should be considered in the T1DM assessment to optimize quality of life.
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Affiliation(s)
- Noémie Topalian
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg
| | - Sylvie Picard
- Endocrinology and Diabetes, Point Medical, Rond-Point de la Nation, Dijon, 21000, France
| | - Jean-Pierre Riveline
- Institut Necker Enfants Malades, INSERM U1151, CNRS UMR 8253, IMMEDIAB Laboratory, Paris, France; Centre Universitaire du diabète et de ses complications, APHP, Lariboisière Hospital et University Paris-Cité, Paris, Île-de-France, , 75010, France
| | - Dulce Canha
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg; Faculty of Science, Technology and Medicine, University of Luxembourg, Luxembourg
| | - Jean-Baptiste Julla
- Institut Necker Enfants Malades, INSERM U1151, CNRS UMR 8253, IMMEDIAB Laboratory, Paris, France; Centre Universitaire du diabète et de ses complications, APHP, Lariboisière Hospital et University Paris-Cité, Paris, Île-de-France, , 75010, France
| | - Sandrine Lablanche
- Grenoble Alpes University, Endocrinology, Diabetology, Nutrition Department, CS 10217, 38043, Grenoble Cedex
| | - Laurence Salle
- Endocrinology and Diabetology Department, CHU Limoges, Inserm U1094, IRD U270, Univ. Limoges, EpiMaCT - OmegaHealth, Limoges, France
| | - Emmanuel Sonnet
- Endocrinology and Diabetology Department, CHU Brest, Brest, France
| | - Aurélie Berot
- CHU de Reims - American Memorial Hospital - Service de Pédiatrie, 47 rue Cognac Jay, 51092, Reims Cedex, France
| | - Didier Gouet
- Endocrinology and Diabetology Department, La Rochelle Regional Hospital, France
| | - Kalliopi Bilariki
- Endocrinology and Diabetology Department, Compiegne-Noyon Regional Hospital, France
| | - Chloé Amouyal
- Sorbonne Université, INSERM, Unité NutriOmique, AP-HP, Hôpital Pitié-Salpêtrière, F-75013, Paris, France
| | - Lucien Marchand
- Service de Diabétologie et d'Endocrinologie, Hôpital Saint Joseph Saint Luc, 20 Quai Claude Bernard, 69007, Lyon, France
| | - Sophie Borot
- Besançon University Hospital, University of Franche-Comté, UMR1080
| | | | - Isabela Banu
- Paris Saint Joseph Hospital Group, Diabetology, Endocrinology and Nutrition, Paris, France
| | | | - Emmanuel Cosson
- Department of Endocrinology-Diabetology-Nutrition, AP-HP, Avicenne Hospital, Paris 13 University, Sorbonne Paris Cité, CRNH-IdF, CINFO, Bobigny, France; Equipe de Recherche en Epidémiologie Nutritionnelle (EREN), Université Sorbonne Paris Nord and Université Paris Cité, INSERM, INRAE, CNAM, Center of Research in Epidemiology and StatisticS (CRESS), Bobigny, France
| | - Guy Fagherazzi
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg.
| | - Gloria Aguayo
- Deep Digital Phenotyping Research Unit, Department of Precision Health, Luxembourg Institute of Health, 1A-B, rue Thomas Edison, L-1445, Strassen, Luxembourg
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Ji XL, Yin M, Deng C, Fan L, Xie YT, Huang FS, Chen Y, Li X. Hemoglobin glycation index among adults with type 1 diabetes: Association with double diabetes features. World J Diabetes 2025; 16:100917. [PMID: 40236850 PMCID: PMC11947909 DOI: 10.4239/wjd.v16.i4.100917] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/01/2024] [Revised: 12/24/2024] [Accepted: 01/16/2025] [Indexed: 02/28/2025] Open
Abstract
BACKGROUND The hemoglobin glycation index (HGI) represents the discrepancy between the glucose management indicator (GMI) based on mean blood glucose levels and laboratory values of glycated hemoglobin (HbA1c). The HGI is a promising indicator for identifying individuals with excessive glycosylation, facilitating personalized evaluation and prediction of diabetic complications. However, the factors influencing the HGI in patients with type 1 diabetes (T1D) remain unclear. Autoimmune destruction of pancreatic β cells is central in T1D pathogenesis, yet insulin resistance can also be a feature of patients with T1D and their coexistence is called "double diabetes" (DD). However, knowledge regarding the relationship between DD features and the HGI in T1D is limited. AIM To assess the association between the HGI and DD features in adults with T1D. METHODS A total of 83 patients with T1D were recruited for this cross-sectional study. Laboratory HbA1c and GMI from continuous glucose monitoring data were collected to calculate the HGI. DD features included a family history of type 2 diabetes, overweight/obesity/central adiposity, hypertension, atherogenic dyslipidemia, an abnormal percentage of body fat (PBF) and/or visceral fat area (VFA) and decreased estimated insulin sensitivity. Skin autofluorescence of advanced glycation end products (SAF-AGEs), diabetic complications, and DD features were assessed, and their association with the HGI was analyzed. RESULTS A discrepancy was observed between HbA1c and GMI among patients with T1D and DD. A higher HGI was associated with an increased number of SAF-AGEs and a higher prevalence of diabetic microangiopathy (P = 0.030), particularly retinopathy (P = 0.031). Patients with three or more DD features exhibited an eight-fold increased risk of having a high HGI, compared with those without DD features (adjusted odds ratio = 8.12; 95% confidence interval: 1.52-43.47). Specifically, an elevated PBF and/or VFA and decreased estimated insulin sensitivity were associated with high HGI. Regression analysis identified estimated insulin sensitivity and VFA as factors independently associated with HGI. CONCLUSION In patients with T1D, DD features are associated with a higher HGI, which represents a trend toward excessive glycosylation and is associated with a higher prevalence of chronic diabetic complications.
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Affiliation(s)
- Xiao-Lin Ji
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
- Department of Endocrinology, The First Affiliated Hospital, Southwest Hospital, Army Medical University, Chongqing 400038, China
| | - Min Yin
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
- Department of Nutrition, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Chao Deng
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Li Fan
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Yu-Ting Xie
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Fan-Su Huang
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
- Department of Nutrition, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Yan Chen
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
| | - Xia Li
- National Clinical Research Center for Metabolic Diseases, Key Laboratory of Diabetes Immunology (Central South University), Ministry of Education, and Department of Metabolism and Endocrinology, The Second Xiangya Hospital of Central South University, Changsha 410011, Hunan Province, China
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21
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Holder M, Kamrath C, Lange K, Kummer S, Ziegler R. Diagnosis, Therapy and Follow-Up of Type 1 Diabetes Mellitus in Children and Adolescents. Exp Clin Endocrinol Diabetes 2025; 133:205-223. [PMID: 40328265 DOI: 10.1055/a-2490-5096] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 05/08/2025]
Affiliation(s)
- Martin Holder
- Olgahospital, Stuttgart Hospital, Stuttgart, Germany
| | | | - Karin Lange
- Hannover Medical School (MHH), Hannover, Germany
| | | | - Ralph Ziegler
- Diabetological Practice for Children and Adolescents, Münster, Germany
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22
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Chan J, Jackson N, Gonzalez Rebollar A, Santana C, Perez de la Garza G, Moin T, Yee JK, Everett E. Association Between Self-Monitored Blood Glucose and Continuous Glucose Monitoring in Youth With Type 1 Diabetes and Medicaid Insurance. Diabetes Care 2025; 48:632-638. [PMID: 39950997 DOI: 10.2337/dc24-2224] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/10/2024] [Accepted: 01/23/2025] [Indexed: 03/20/2025]
Abstract
OBJECTIVE Youth with type 1 diabetes (T1D) and Medicaid must demonstrate they have self-monitored their blood glucose level at least four times daily to receive continuous glucose monitors (CGMs). New California Medicaid policies eliminated this requirement and, thus, CGM access has increased. This study examines whether infrequent baseline self-monitored blood glucose (SMBG) checks result in suboptimal outcomes or nonadherence with CGM use. RESEARCH DESIGN AND METHODS This retrospective study included youth with T1D and Medicaid who started CGM after January 2019, when newer models no longer needed calibration, at two large health care systems. Patients were stratified by data on baseline SMBG frequency (<4 vs. ≥4 checks daily) collected at the clinic visit prior to starting CGM. Differences between SMBG groups in CGM adherence and HbA1c over time were assessed by a mixed-effects linear regression model and fixed-effect interaction term. Patients were surveyed to explore individual impact of CGM on diabetes management. RESULTS We followed 78 youth for 6 months. CGM adherence was similar between SMBG frequency groups at 3 months (68.7% vs. 68.4%; P = 0.97) and sustained at 6 months. HbA1c values improved in both groups at 3 months, with a larger improvement in those with SMBG <4 daily checks (1.3% vs. 0.4%), and sustained at 6 months. Patient surveys (n = 35) reported high engagement with CGM and increased insulin boluses after initiation. CONCLUSIONS Patients using CGM demonstrated improvement in HbA1c regardless of prior SMBG. Increased engagement with CGM likely promoted increased insulin boluses. Therefore, restriction of CGM to those with SMBG ≥4 daily checks is an unnecessary barrier, excluding those who could potentially benefit the most.
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Affiliation(s)
- Janice Chan
- Division of Endocrinology, Department of Pediatrics, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
| | - Nicholas Jackson
- Statistics Core, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
| | | | - Cynthia Santana
- Division of Endocrinology, Diabetes, & Metabolism, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
| | | | - Tannaz Moin
- Division of Endocrinology, Diabetes, & Metabolism, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
- Division of General Internal Medicine & Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
- VA Greater Los Angeles Healthcare System, Los Angeles, CA
| | - Jennifer K Yee
- The Lundquist Institute of Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, CA
- Division of Endocrinology, Department of Pediatrics, Harbor-UCLA Medical Center, Torrance, CA
| | - Estelle Everett
- Division of Endocrinology, Diabetes, & Metabolism, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
- Division of General Internal Medicine & Health Services Research, Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA
- VA Greater Los Angeles Healthcare System, Los Angeles, CA
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23
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Fernando K, Alabraba V, Welsh JB, Seidu S, Strain WD, Bell HE, Davies S, Evans M. Practical Approaches to Continuous Glucose Monitoring in Primary Care: A UK-Based Consensus Opinion. Diabetes Ther 2025; 16:749-762. [PMID: 40016572 PMCID: PMC11925819 DOI: 10.1007/s13300-025-01706-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/11/2025] [Accepted: 02/10/2025] [Indexed: 03/01/2025] Open
Abstract
INTRODUCTION Type 2 diabetes (T2D) imposes significant personal challenges and societal costs. Continuous glucose monitoring (CGM) is recognised as a state-of-the-art tool, but remains underutilised. Adoption of CGM in primary care should be informed by a broader understanding of the technology's capabilities and limitations. METHODS An expert panel was convened to review current literature and clinical experience to provide practical approaches to CGM for primary care practitioners and discuss the technology's value in the routine management of T2D. The goals were to review and reach consensus on the current state of CGM in non-specialist practice settings and on strategies for successfully initiating and maintaining people on CGM. RESULTS Initiation and maintenance of CGM therapy can be successfully conducted in primary care settings. CGM therapy should include proper patient selection, proper setting of expectations, and evidence-based adjustments to therapy. Most patients are likely to see quick, meaningful, and lasting improvements in their diabetes, along with a better understanding of their condition and greater motivation for successful management. Retrospective report interpretation is feasible and intuitive. Barriers to adoption and sustained use include cost, technological limitations, behavioural or psychological factors, and therapeutic inertia. Addressing these barriers is critical to enable better access to CGM. Continuous glucose monitoring can be leveraged by primary care teams to inform treatment decisions and also by patients to inform diabetes self-management. CONCLUSION CGM should be considered for all people with T2D. The recommendations provided here should simplify adoption and maintenance use of CGM in primary care and maximise the glycaemic and psychosocial benefits of the technology.
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Affiliation(s)
| | - Vicki Alabraba
- Leicester Diabetes Centre, University Hospitals Leicester NHS Trust and Pinfold Medical Practice, Loughborough, UK
| | | | | | | | | | | | - Marc Evans
- University Hospital Llandough, Cardiff, UK
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24
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Frías JP, Ratzki‐Leewing A, Dex T, Meneghini L, Rodrigues A, Shah VN. Effect of iGlarLixi on continuous glucose monitoring-measured time in range in insulin-naive adults with suboptimally controlled type 2 diabetes. Diabetes Obes Metab 2025; 27:2173-2182. [PMID: 39905643 PMCID: PMC11885071 DOI: 10.1111/dom.16214] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/14/2024] [Revised: 01/10/2025] [Accepted: 01/13/2025] [Indexed: 02/06/2025]
Abstract
AIMS People with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) ≥9% may benefit from fixed-ratio combination therapies such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL). Use of continuous glucose monitoring (CGM) is recommended, but data are lacking to assess the impact of iGlarLixi in individuals with HbA1c ≥9%. MATERIALS AND METHODS Soli-CGM (NCT05114590) was a 16-week, multicentre, open-label study evaluating the efficacy of once-daily iGlarLixi using blinded CGM-based metrics in insulin-naive adults with HbA1c ≥9%-13% who were receiving ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The primary outcome was the change from baseline to week 16 in percent time in range (TIR; 70-180 mg/dL). Secondary outcomes included change in mean daily blood glucose (BG), maximum postprandial glucose 4 h post-breakfast (PPG-4 h), and time above range (TAR; >180 mg/dL). On-treatment hypoglycaemia was assessed. RESULTS The study enrolled 124 participants (mean age, 55.6 years; HbA1c, 10.2%). Sixteen weeks of treatment with iGlarLixi improved TIR (+26.2%), mean BG (-52.5 mg/dL), maximum PPG-4 h (-73.7 mg/dL), and TAR (-28.7%); all p < 0.001. Rates of American Diabetes Association level 1 (BG <70 but ≥54 mg/dL) and level 2 (BG <54 mg/dL) hypoglycaemia were reported as 1.4 and 0.6 events per person-year, respectively. No level 3 events (requiring assistance) were reported. CONCLUSIONS In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RAs, 16 weeks of treatment with iGlarLixi significantly improved TIR and reduced TAR without severe hypoglycaemia.
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Affiliation(s)
| | - Alexandria Ratzki‐Leewing
- University of Maryland Institute for Health ComputingBethesdaMarylandUSA
- Division of Gerontology, Department of Epidemiology and Public HealthUniversity of Maryland School of MedicineBaltimoreMarylandUSA
- Department of Epidemiology and BiostatisticsWestern UniversityLondonOntarioCanada
| | | | | | | | - Viral N. Shah
- Indiana University School of MedicineIndianapolisIndianaUSA
- Indiana University Center for Diabetes and Metabolic DiseasesIndiana University School of MedicineIndianapolisIndianaUSA
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25
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de Boer IH, Anderson LD, Ashford NK, Ayers E, Bansal N, Hall YN, Hirsch IB, Hoofnagle AN, Hsu S, Jones E, Lidgard B, Limonte CP, Linke LJ, Marnell CC, Mayeda L, McNamara E, Mehrotra R, Pesenson A, Porter JM, Rivara MB, Roberts GV, Shanaman B, Trikudanathan S, Watnick S, Wilkens KG, Zelnick LR. Glycemia Assessed by Continuous Glucose Monitoring among People Treated with Maintenance Dialysis. J Am Soc Nephrol 2025:00001751-990000000-00590. [PMID: 40117214 DOI: 10.1681/asn.0000000693] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/09/2024] [Accepted: 03/18/2025] [Indexed: 03/23/2025] Open
Abstract
Key Points
In maintenance dialysis, continuous glucose monitoring frequently identified both hyperglycemia and hypoglycemia that may not be clinically evident.Patients with treated diabetes rarely met contemporary continuous glucose monitoring–based treatment targets.
Background
Kidney failure and its treatments disrupt glucose homeostasis in ways that may promote both hyperglycemia and hypoglycemia. Continuous glucose monitoring (CGM) delineates detailed glycemic profiles, but published studies in kidney failure are limited to small, select groups. We aimed to characterize the spectrum of glycemia and its determinants in a large, diverse maintenance dialysis population.
Methods
We conducted a prospective community-based cohort study of people treated with maintenance dialysis. Each participant wore a Dexcom G6 Pro CGM for approximately 10 days. Outcomes ascertained by CGM included mean blood glucose, time in range (TIR, 70–180 mg/dl), and hypoglycemia events (sustained <70 mg/dl).
Results
We enrolled 420 demographically diverse participants, including 263 with diabetes (of whom 88 were untreated with glucose-lowering medications) and 157 without diabetes. Peritoneal dialysis (PD) was used by 55 participants. Outcomes varied by diabetes status and dialysis modality. Among participants without diabetes, mean blood glucose was higher with PD versus hemodialysis (141 versus 121 mg/dl, P < 0.001). Among participants with untreated diabetes, the mean blood glucose was 162 mg/dl, mean TIR 71%, and only 64% of participants attained TIR ≥70%, while mean hemoglobin A1c (HbA1c) was 5.7%. Among participants with treated diabetes, the mean blood glucose was 214 mg/dl, the mean TIR was 43%, and only 22% of participants attained TIR ≥70%, while the mean HbA1c was 7.0%. In total, 714 unique sustained hypoglycemia events were observed, with highest rates for participants without diabetes. In addition to diabetes and dialysis modality, age, dialysis vintage, insulin use, HbA1c, and serum albumin were significantly associated with mean blood glucose, hypoglycemia, or both.
Conclusions
In maintenance dialysis, CGM frequently identified both hyperglycemia and hypoglycemia that may not be clinically evident. In particular, hyperglycemia was common with PD, patients with untreated diabetes maintained a diabetic glycemic profile, and patients with treated diabetes rarely met contemporary CGM-based treatment targets.
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Affiliation(s)
- Ian H de Boer
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- VA Puget Sound Health Care System, Seattle, Washington
| | - Lisa D Anderson
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Nathaniel K Ashford
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Ernest Ayers
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Nisha Bansal
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Yoshio N Hall
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- VA Puget Sound Health Care System, Seattle, Washington
| | - Irl B Hirsch
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington, Seattle, Washington
| | - Andrew N Hoofnagle
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- Department of Laboratory Medicine and Pathology, University of Washington, Seattle, Washington
| | - Simon Hsu
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Evelin Jones
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Benjamin Lidgard
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Christine P Limonte
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Lori J Linke
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | | | - Laura Mayeda
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | | | - Rajnish Mehrotra
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | | | - Julie M Porter
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | - Matthew B Rivara
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- Northwest Kidney Centers, Seattle, Washington
| | - Glenda V Roberts
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
| | | | - Subbulaxmi Trikudanathan
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- Division of Metabolism, Endocrinology, and Nutrition, Department of Medicine, University of Washington, Seattle, Washington
| | - Suzanne Watnick
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
- Northwest Kidney Centers, Seattle, Washington
| | | | - Leila R Zelnick
- Division of Nephrology, Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington
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Piloya-Were T, Nyangabayaki C, Dunn TC, Malinga D, Nambooze J, Pappenfus E, Zhang L, Bindal A, Beasley S, Sunni M, Nathan BM, Liu S, Moran A. Personalized Hemoglobin A1c Shows Better Correlation with Mean Glucose than Laboratory Hemoglobin A1c in Ugandan Youth with Type 1 Diabetes, but Mean Glucose Is Not Clinically Useful in This Population Due to Extreme Glucose Variability. Diabetes Technol Ther 2025. [PMID: 40111862 DOI: 10.1089/dia.2024.0537] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 03/22/2025]
Abstract
Introduction: Continuous glucose monitoring (CGM) is unaffordable in sub-Saharan Africa, and providers rely heavily on hemoglobin A1c (A1c) to guide insulin adjustment. The relationship between A1c and mean glucose (MG) varies between individuals and populations. We assessed this relationship in Ugandan youth of age 4-26 years with type 1 diabetes, and evaluated whether calculation of the personalized A1c (pA1c), which only requires a brief initial sensor wear, is clinically useful. Materials and Methods: CGM data were averaged across three blinded sensor wears (31-41 days). We calculated individual apparent glycation ratios using A1c after the second sensor, and applied these to A1cs collected after the third sensor to determine pA1c. Participants were evaluated for clinical factors that influence red blood cell (RBC) lifespan (malaria, G6PD deficiency, sickle-cell trait, hemolysis, iron deficiency). Results: Patients across the A1c spectrum experienced substantial time in both hyper- and hypoglycemia; average coefficient of variation was 44%. MG was >250 mg/dL (13.9 mmol/L) in 50% of participants, and 55% of participants spent ≥4% time with glucose <70 mg/dL (3.9 mmol/L). There was considerable variability in the A1c-MG relationship. The pA1c more accurately represented MG by significantly reducing variation in this relationship (R2 = 0.84 vs. 0.40; r = 0.92 vs. 0.63), but MG is not useful in individuals with the wide glucose fluctuations seen in this population. Clinical factors did not impact the A1c-MG relationship. Conclusions: Neither the measured A1c nor the calculated pA1c provided reliable guidance for insulin adjustment in this population. No matter how accurately MG is measured or estimated, it is just an average, with limited clinical application in individuals with wide glycemic variation. These measures cannot replace the information available from CGM about glycemic excursion, daily glucose patterns, or percent time in various glucose ranges. Our data suggest that it is essential to find a way to make CGM at least periodically affordable in low-resource settings.
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Affiliation(s)
- Thereza Piloya-Were
- Department of Pediatrics, Makerere University College of Health Sciences, Kampala, Uganda
| | | | | | - Daniel Malinga
- Department of Pediatrics, Makerere University College of Health Sciences, Kampala, Uganda
| | - Jemima Nambooze
- Department of Pediatrics, Makerere University College of Health Sciences, Kampala, Uganda
| | - Elizabeth Pappenfus
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
| | - Lin Zhang
- Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota, USA
| | | | - Shannon Beasley
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
| | - Muna Sunni
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
| | - Brandon M Nathan
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
| | - Sandy Liu
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
| | - Antoinette Moran
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, University of Minnesota, Minneapolis, Minnesota, USA
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27
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Lazar S, Potre O, Ionita I, Reurean-Pintilei DV, Timar R, Herascu A, Avram VF, Timar B. The Usefulness of the Glucose Management Indicator in Evaluating the Quality of Glycemic Control in Patients with Type 1 Diabetes Using Continuous Glucose Monitoring Sensors: A Cross-Sectional, Multicenter Study. BIOSENSORS 2025; 15:190. [PMID: 40136987 PMCID: PMC11940097 DOI: 10.3390/bios15030190] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 11/07/2024] [Revised: 03/13/2025] [Accepted: 03/14/2025] [Indexed: 03/27/2025]
Abstract
The Glucose Management Indicator (GMI) is a biomarker of glycemic control which estimates hemoglobin A1c (HbA1c) based on the average glycemia recorded by continuous glucose monitoring sensors (CGMS). The GMI provides an immediate overview of the patient's glycemic control, but it might be biased by the patient's sensor wear adherence or by the sensor's reading errors. This study aims to evaluate the GMI's performance in the assessment of glycemic control and to identify the factors leading to erroneous estimates. In this study, 147 patients with type 1 diabetes, users of CGMS, were enrolled. Their GMI was extracted from the sensor's report and HbA1c measured at certified laboratories. The median GMI value overestimated the HbA1c by 0.1 percentage points (p = 0.007). The measurements had good reliability, demonstrated by a Cronbach's alpha index of 0.74, an inter-item correlation coefficient of 0.683 and an inter-item covariance between HbA1c and GMI of 0.813. The HbA1c and the difference between GMI and HbA1c were reversely associated (Spearman's r = -0.707; p < 0.001). The GMI is a reliable tool in evaluating glycemic control in patients with diabetes. It tends to underestimate the HbA1c in patients with high HbA1c values, while it tends to overestimate the HbA1c in patients with low HbA1c.
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Affiliation(s)
- Sandra Lazar
- First Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.L.); (I.I.)
- Department of Hematology, Emergency Municipal Hospital, 300254 Timisoara, Romania
- Centre for Molecular Research in Nephrology and Vascular Disease, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (R.T.); (A.H.); (V.F.A.); (B.T.)
| | - Ovidiu Potre
- First Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.L.); (I.I.)
- Department of Hematology, Emergency Municipal Hospital, 300254 Timisoara, Romania
- Multidisciplinary Research Center for Malignant Hematological Diseases (CCMHM), Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania
| | - Ioana Ionita
- First Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (S.L.); (I.I.)
- Department of Hematology, Emergency Municipal Hospital, 300254 Timisoara, Romania
- Multidisciplinary Research Center for Malignant Hematological Diseases (CCMHM), Victor Babes University of Medicine and Pharmacy, 300041 Timisoara, Romania
| | - Delia-Viola Reurean-Pintilei
- Department of Medical-Surgical and Complementary Sciences, Faculty of Medicine and Biological Sciences, “Stefan cel Mare” University, 720229 Suceava, Romania;
- Department of Diabetes, Nutrition and Metabolic Diseases, Consultmed Medical Centre, 700544 Iasi, Romania
| | - Romulus Timar
- Centre for Molecular Research in Nephrology and Vascular Disease, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (R.T.); (A.H.); (V.F.A.); (B.T.)
- Second Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania
- Department of Diabetes, “Pius Brinzeu” Emergency Hospital, 300723 Timisoara, Romania
| | - Andreea Herascu
- Centre for Molecular Research in Nephrology and Vascular Disease, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (R.T.); (A.H.); (V.F.A.); (B.T.)
- Second Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania
- Department of Diabetes, “Pius Brinzeu” Emergency Hospital, 300723 Timisoara, Romania
| | - Vlad Florian Avram
- Centre for Molecular Research in Nephrology and Vascular Disease, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (R.T.); (A.H.); (V.F.A.); (B.T.)
- Second Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania
- Department of Diabetes, “Pius Brinzeu” Emergency Hospital, 300723 Timisoara, Romania
| | - Bogdan Timar
- Centre for Molecular Research in Nephrology and Vascular Disease, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania; (R.T.); (A.H.); (V.F.A.); (B.T.)
- Second Department of Internal Medicine, “Victor Babes” University of Medicine and Pharmacy, 300041 Timisoara, Romania
- Department of Diabetes, “Pius Brinzeu” Emergency Hospital, 300723 Timisoara, Romania
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Bilbie-Lupchian L, Oliván-Blázquez B, González-Álvarez B, Matovelle-Ochoa P, Casado-Vicente V, Sánchez-Calavera MA. Evolution of the population with chronic kidney disease in Spain in the context of the COVID-19 pandemic: a longitudinal retrospective study. Prim Health Care Res Dev 2025; 26:e26. [PMID: 40041980 PMCID: PMC11883795 DOI: 10.1017/s1463423625000155] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/04/2023] [Revised: 10/03/2024] [Accepted: 10/15/2024] [Indexed: 03/09/2025] Open
Abstract
OBJECTIVES To analyze the sociodemographic characteristics and trends in clinical and analytical parameters among individuals with chronic kidney disease (CKD) in Aragon (Spain), who remain uninfected with COVID-19 during the first year of pandemic. The secondary objectives were to identify the associated comorbidities and their evolution throughout the pandemic, as well as to determine the cases that got worse and their possible relationship with the control of the main risk factors. BACKGROUND CKD is a major public health problem worldwide. Studies encompassing national, European, and global contexts, show a rise in the prevalence of CKD, with a significant decrease in life quality, high morbidity and mortality, and increased healthcare costs. In this scenario, primary care is a cornerstone for the early detection of CKD and for the management of progression factors. To date, there are few publications regarding the evolution of the CKD population throughout the pandemic that are not related to hospitalizations or complications due to COVID-19. METHODS We conducted a retrospective longitudinal study with real-world data from the population over 16 years of age registered in Aragon (Spain), collecting data from electronic health records. The variables included were sociodemographic, analytical and clinical (glomerular filtration rate, cholesterol, triglycerides, glycated haemoglobin, and blood pressure) and comorbidities (hypertension, dyslipidemia, obesity, diabetes, and smoking). The data were archived and processed using the SPSS v22.0 software package. RESULTS During the first six months of COVID-19 pandemic, the clinical parameters of people with CKD were poorly controlled, although there was a later improvement which could be related to the progressive recovery of health services. The glycated haemoglobin value found was low, which makes us suspect possible overtreatment. There is a high prevalence of high blood pressure, diabetes, dyslipidemia, obesity and smoking. Interventions targeting these factors could help reduce the burden of CKD.
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Affiliation(s)
- Liliana Bilbie-Lupchian
- Aragonese Health Services, Zaragoza, Spain
- Institute for Health Research Aragón (IISA), Zaragoza, Spain
| | - Bárbara Oliván-Blázquez
- Institute for Health Research Aragón (IISA), Zaragoza, Spain
- Department of Psychology and Sociology, University of Zaragoza, Zaragoza, Spain
| | - Beatriz González-Álvarez
- Scientific Technical Services – Biocomputing, Aragonese Institute of Health Sciences (IACS), Zaragoza, Spain
| | - Priscila Matovelle-Ochoa
- Geriatrics Department, San Juan de Dios Hospital, Zaragoza, Spain
- Department of Medicine, Psychiatry and Dermatology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain
| | | | - María Antonia Sánchez-Calavera
- Aragonese Health Services, Zaragoza, Spain
- Institute for Health Research Aragón (IISA), Zaragoza, Spain
- Department of Medicine, Psychiatry and Dermatology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain
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29
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Ganji M, El Fathi A, Fabris C, Lv D, Kovatchev B, Breton M. Distribution-based sub-population selection (DSPS): A method for in-silico reproduction of clinical trials outcomes. Comput Biol Med 2025; 186:109714. [PMID: 39837001 DOI: 10.1016/j.compbiomed.2025.109714] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/04/2024] [Revised: 01/09/2025] [Accepted: 01/16/2025] [Indexed: 01/23/2025]
Abstract
Diabetes presents a significant challenge to healthcare due to the short- and long-term complications associated with poor blood sugar control. Computer simulation platforms have emerged as promising tools for advancing diabetes therapy by simulating patient responses to treatments in a virtual environment. The University of Virginia Virtual Lab (UVLab) is a new simulation platform engineered to mimic the metabolic behavior of individuals with type 2 diabetes (T2D) using a mathematical model of glucose homeostasis in T2D and a large population of 6062 virtual subjects. This work proposes a statistical method - the Distribution-based sub-population selection (DSPS) method - for selecting subsets of virtual subjects from this large initial pool, ensuring that the selected group possesses the desired characteristics necessary to reproduce and predict the outcomes of a clinical trial. DSPS formulates the sub-population selection as a linear programming problem, identifying the largest virtual cohort to closely resemble the statistical properties (moments) of key outcomes from real-world clinical trials. The method was applied to the insulin degludec arm of a 26-week phase 3 clinical trial, evaluating the efficacy and safety of insulin degludec and liraglutide combination therapy. DSPS selected a sub-population that mirrored clinical trial data across key metrics, including glycemic efficacy, insulin dosages, and cumulative hypoglycemia events, with a relative sum of square errors of 0.33 and a percentage error of 1.07 %. This approach bridges the gap between large population simulation platforms and clinical trials, enabling the selection of virtual sub-populations with specific properties required for targeted studies.
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Affiliation(s)
- Mohammadreza Ganji
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
| | - Anas El Fathi
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
| | - Chiara Fabris
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
| | - Dayu Lv
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
| | - Boris Kovatchev
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
| | - Marc Breton
- University of Virginia, Center for Diabetes Technology, Charlottesville, VA, 22903, USA.
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Leite RO, Brodar KE, Saab PG, Marchetti D, Jaramillo M, Sanchez J, Davis E, Delamater AM, La Greca AM. Diabetes Care and Mental Health During the COVID-19 Pandemic: Perspectives of Adolescents with Diabetes, Parents, and Providers. J Clin Psychol Med Settings 2025; 32:70-86. [PMID: 38281304 DOI: 10.1007/s10880-023-09995-9] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 12/04/2023] [Indexed: 01/30/2024]
Abstract
This study explored ways in which the COVID-19 pandemic impacted adolescents' diabetes management and psychosocial functioning, and how adolescents, parents, and providers viewed telemedicine. We present data from three studies: (1) a comparison of psychosocial functioning and glycemic levels before and after pandemic onset (n = 120 adolescents; 89% with type 1 diabetes), (2) an online survey of parents about pandemic-related stressors (n = 141), and (3) qualitative interviews with adolescents, parents, and medical providers about the pandemic's impacts on adolescents' diabetes care and mental health (n = 13 parent-adolescent dyads; 7 medical providers). Results suggested some adverse effects, including disrupting routines related to health behaviors and psychosocial functioning and impairing adolescents' quality of life. Despite these challenges, most participants did not endorse significant impacts. Some even noted benefits, such as increased parental supervision of diabetes management that can be leveraged beyond the pandemic. Furthermore, telemedicine offers benefits to continuity of diabetes care but presents challenges to care quality. These findings underscore the varied and unique impacts of the COVID-19 pandemic on adolescents with diabetes.
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Affiliation(s)
- Rafael O Leite
- Department of Psychology, University of Miami, 5665 Ponce de Leon Blvd., Flipse Building 420, Coral Gables, FL, 33136, USA.
| | | | - Patrice G Saab
- Department of Psychology, University of Miami, 5665 Ponce de Leon Blvd., Flipse Building 420, Coral Gables, FL, 33136, USA
| | - Daniella Marchetti
- Psychology Service, Bruce W. Carter Medical Center, Miami VA Healthcare System, Miami, FL, USA
| | - Manuela Jaramillo
- Department of Psychology, University of Miami, 5665 Ponce de Leon Blvd., Flipse Building 420, Coral Gables, FL, 33136, USA
| | - Janine Sanchez
- Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Eileen Davis
- Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Alan M Delamater
- Department of Pediatrics, University of Miami Miller School of Medicine, Miami, FL, USA
| | - Annette M La Greca
- Department of Psychology, University of Miami, 5665 Ponce de Leon Blvd., Flipse Building 420, Coral Gables, FL, 33136, USA
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Kovatchev BP, Lobo B, Fabris C, Ganji M, El Fathi A, Breton MD, Kanapka L, Kollman C, Battelino T, Beck RW. The Virtual DCCT: Adding Continuous Glucose Monitoring to a Landmark Clinical Trial for Prediction of Microvascular Complications. Diabetes Technol Ther 2025; 27:209-216. [PMID: 39772614 DOI: 10.1089/dia.2024.0404] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/11/2025]
Abstract
Objective: Using a multistep machine-learning procedure, add virtual continuous glucose monitoring (CGM) traces to the original sparse data of the landmark Diabetes Control and Complications Trial (DCCT). Assess the association of CGM metrics with the microvascular complications of type 1 diabetes observed during the DCCT and establish time-in-range (TIR) as a viable marker of glycemic control. Research Design and Methods: Utilizing the DCCT glycated hemoglobin data obtained every 1 or 3 months plus quarterly 7-point blood glucose (BG) profiles in a multistep procedure: (i) utilized archival BG traces to model interday BG variability and estimate glycated hemoglobin; (ii) trained across the DCCT BG profiles and associated each profile with an archival BG trace; and (iii) used previously identified CGM "motifs" to associate a CGM trace to a BG trace, for each DCCT participant. Results: TIR (70-180 mg/dL) computed from virtual CGM data over 14 days prior to each glycated hemoglobin measurement reproduced the observed glycemic control differences between the intensive and conventional DCCT groups, with TIR generally >60% and <40% in these groups, respectively. Similar to glycated hemoglobin, TIR was associated with the risk of development or progression of retinopathy, nephropathy, and neuropathy (all P-values <0.0001). Poisson regressions indicated that TIR predicted retinopathy and microalbuminuria similarly to the original glycated hemoglobin data. Conclusions: The landmark DCCT was revisited using contemporary data science methods, which allowed adding individual CGM traces to the original data. Fourteen-day CGM metrics predicted microvascular diabetes complications similarly to glycated hemoglobin. Clinical Trials Registration: Not a clinical trial.
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Affiliation(s)
- Boris P Kovatchev
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
- School of Data Science, University of Virginia, Charlottesville, VA, USA
| | - Benjamin Lobo
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
- School of Data Science, University of Virginia, Charlottesville, VA, USA
| | - Chiara Fabris
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
| | - Mohammadreza Ganji
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
| | - Anas El Fathi
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
| | - Marc D Breton
- Center for Diabetes Technology, University of Virginia, Charlottesville, VA, USA
| | | | | | - Tadej Battelino
- University Medical Center Ljubljana, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Roy W Beck
- Jaeb Center for Health Research, Tampa, FL, USA
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Zoet S, Urgert T, Veldhuis A, van Beijnum BJ, Laverman GD. Quantification of the relation between continuous glucose monitoring observation period and the estimation error in assessing long-term glucose regulation. BMJ Open Diabetes Res Care 2025; 13:e004768. [PMID: 40011057 PMCID: PMC11865789 DOI: 10.1136/bmjdrc-2024-004768] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2024] [Accepted: 02/09/2025] [Indexed: 02/28/2025] Open
Abstract
INTRODUCTION The integration of continuous glucose monitoring (CGM) into clinical practice has rapidly emerged in the last decade, changing the evaluation of long-term glucose regulation in patients with diabetes. When using CGM-derived metrics to evaluate long-term glucose regulation, it is essential to determine the minimal observation period necessary for a reliable estimate. The approach of this study was to calculate mean absolute errors (MAEs) for varying window lengths, with the goal of demonstrating how the CGM observation period influences the accuracy of the estimation of 90-day glycemic control. RESEARCH DESIGN AND METHODS CGM data were collected from the DIABASE cohort (ZGT hospital, The Netherlands). Trailing aggregates (TAs) were calculated for four CGM-derived metrics: time in range (TIR), time below range (TBR), glucose management indicator (GMI) and glycemic variability (GV). Arbitrary MAEs for each patient were compared between the TAs of window lengths from 1 to 89 days and a reference TA of 90 days, which is assumed to reflect long-term glycemic regulation. RESULTS Using 14 days of CGM data resulted in 65% of subjects having their TIR estimation being below a MAE threshold of 5%. In order to have 90% of the subjects below a TIR MAE threshold of 5%, the observation period needs to be 29 days. CONCLUSIONS Although there is currently no consensus on what is an acceptable MAE, this study provides insight into how MAEs of CGM-derived metrics change according to the used observation period within a population and may thus be helpful for clinical decision-making.
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Affiliation(s)
- Stennie Zoet
- Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands
- Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo, Overijssel, The Netherlands
| | - Thomas Urgert
- Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands
- Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo, Overijssel, The Netherlands
| | - Anouk Veldhuis
- Department of Health and Information Technology, Ziekenhuisgroep Twente, Almelo, Overijssel, The Netherlands
| | - Bert-Jan van Beijnum
- Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands
| | - Gozewijn D Laverman
- Faculty of Electrical Engineering, Mathematics and Computer Science, University of Twente, Enschede, The Netherlands
- Department of Internal Medicine, Ziekenhuisgroep Twente, Almelo, Overijssel, The Netherlands
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Williamson W, Lee JM, Gaynanova I. A Processing Algorithm to Address Real-World Data Quality Issues With Continuous Glucose Monitoring Data. J Diabetes Sci Technol 2025:19322968251319801. [PMID: 39980261 PMCID: PMC11843558 DOI: 10.1177/19322968251319801] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/22/2025]
Abstract
Continuous glucose monitoring (CGM) data stored in data warehouses often include duplicated or time-shifted uploads from the same patient, compromising data quality and accuracy of resulting CGM metrics. We developed a processing algorithm to detect and resolve these errors. We validated the algorithm using two weeks of CGM data from 2038 patients with diabetes. Duplication errors were identified in 528 patients, with 25.7% showing significant differences in at least one metric (Time in Range, Coefficient of Variation, Glycemic Management Indicator, or Glycemic Episode counts) between raw and processed data. Eleven patients crossed clinically meaningful thresholds in one or more metrics after processing. Our results underscore the importance of real-world CGM data processing to maintain accurate and reliable CGM metrics for research and clinical care.
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Affiliation(s)
- Walter Williamson
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA
| | - Joyce M. Lee
- Susan B. Meister Child Health Evaluation and Research Center, Division of Pediatric Endocrinology, Department of Pediatrics, University of Michigan, Ann Arbor, MI, USA
| | - Irina Gaynanova
- Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI, USA
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Puig-Jové C, Viñals C, Conget I, Quirós C, Vinagre I, Berrocal B, Blanco-Carrasco AJ, Granados M, Mesa A, Serés-Noriega T, Giménez M, Perea V, Amor AJ. Association between the GMI/HbA1c ratio and preclinical carotid atherosclerosis in type 1 diabetes: impact of the fast-glycator phenotype across age groups. Cardiovasc Diabetol 2025; 24:75. [PMID: 39953520 PMCID: PMC11829493 DOI: 10.1186/s12933-025-02637-4] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/06/2024] [Accepted: 02/06/2025] [Indexed: 02/17/2025] Open
Abstract
BACKGROUND Since the arrival of continuous glucose monitoring (CGM), the relationship between the glucose management indicator (GMI) and HbA1c has been a topic of considerable interest in diabetes research. This study aims to explore the association between the GMI/HbA1c ratio and the presence of preclinical carotid atherosclerosis in type 1 diabetes (T1D). METHODS Individuals with T1D and no prior history of cardiovascular disease were recruited from two centers. Carotid ultrasonography was performed using a standardized protocol and carotid plaques were defined as intima-media thickness ≥ 1.5 mm. CGM-derived data were collected from a 14-day report. A GMI/HbA1c ratio < 0.90 was selected to identify "fast-glycator" phenotype. RESULTS A total of 584 participants were included (319 women, 54.6%), with a mean age of 48.8 ± 10.7 years and a mean diabetes duration of 27.5 ± 11.4 years. Carotid plaques were present in 231 subjects (39.6%). Approximately 43.7% and 13.4% of participants showed absolute differences of ≥ 0.5 and ≥ 1.0 between 14-day GMI and HbA1c, respectively. Among patients ≥ 48 years, the fast-glycator phenotype was independently associated with presence of plaques (OR 2.27, 95%CI: 1.06-4.87), even after adjusting for non-specific and T1D-specific risk factors and statin treatment. No significant association was observed in younger subjects (p for interaction < 0.05). CONCLUSIONS Fast-glycator phenotype is independently associated with atherosclerosis in T1D individuals aged ≥ 48 years, suggesting an age-related increase in the glycation risk. These findings highlight the potential of the GMI/HbA1c ratio for cardiovascular risk stratification in this population.
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Affiliation(s)
- Carlos Puig-Jové
- Endocrinology and Nutrition Department, Hospital Universitari Mútua Terrassa, Dr Robert 5, 08221, Barcelona, Spain
| | - Clara Viñals
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain
| | - Ignacio Conget
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain
| | - Carmen Quirós
- Endocrinology and Nutrition Department, Hospital Universitari Mútua Terrassa, Dr Robert 5, 08221, Barcelona, Spain
| | - Irene Vinagre
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain
| | - Belén Berrocal
- Endocrinology and Nutrition Department, Hospital Universitari Mútua Terrassa, Dr Robert 5, 08221, Barcelona, Spain
| | - Antonio-Jesús Blanco-Carrasco
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain
| | - Montserrat Granados
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Alex Mesa
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Endocrinology and Nutrition Department, Hospital de la Santa Creu i Sant Pau, 08041, Barcelona, Spain
| | - Tonet Serés-Noriega
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
| | - Marga Giménez
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain
| | - Verónica Perea
- Endocrinology and Nutrition Department, Hospital Universitari Mútua Terrassa, Dr Robert 5, 08221, Barcelona, Spain.
| | - Antonio J Amor
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic de Barcelona, Villarroel 170, 08036, Barcelona, Spain.
- Fundació Clínic per a la Recerca Biomèdica (FCRB)-Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), 08036, Barcelona, Spain.
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Cardona-Hernandez R, de la Cuadra-Grande A, Monje J, Echave M, Oyagüez I, Álvarez M, Leiva-Gea I. Are Trends in Economic Modeling of Pediatric Diabetes Mellitus up to Date with the Clinical Practice Guidelines and the Latest Scientific Findings? JOURNAL OF HEALTH ECONOMICS AND OUTCOMES RESEARCH 2025; 12:30-50. [PMID: 39911635 PMCID: PMC11797704 DOI: 10.36469/001c.127920] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Subscribe] [Scholar Register] [Received: 10/29/2024] [Accepted: 12/30/2024] [Indexed: 02/07/2025]
Abstract
Background: Modeling techniques in the field of pediatrics present unique challenges beyond traditional model limitations, and sometimes difficulties in faithfully simulating the condition's evolution over time. Objective: This study aimed to identify whether economic modeling approaches in diabetes in pediatric patients align with the recommendations of clinical practice guidelines and the latest scientific evidence. Methods: A literature review was performed in March 2023 to identify modeling-based economic evaluations in diabetes in pediatric patients. Data were extracted and synthesized from eligible studies. Clinical practice guidelines for diabetes were gathered to compare their alignment with modeling strategies. Two endocrinology specialists provided insights on the latest findings in diabetes that are not yet included in the guidelines. A multidisciplinary group of experts agreed on the relevant themes to conduct the comparative analysis: parameter informing on glycemic control, diabetic ketoacidosis/hypoglycemia, C-peptide as prognostic biomarker, metabolic memory, age at diagnosis, socioeconomic status, pediatric-specific sources of risk equations, and pediatric-specific sources of utilities/disutilities. Results: Nineteen modeling-based studies (7 de novo, 12 predesigned models) and 34 guidelines were selected. Hemoglobin A1c was the main parameter to model the glycemic control; however, guidelines recommend the usage of complementary measures (eg, time in range) which are not included in economic models. Eight models included diabetic ketoacidosis (42.1%), 16 included hypoglycemia (84.2%), 2 included C-peptide (1 of those as prognostic factor) (10.5%) and 1 included legacy effect (5.3%). Neither guidelines nor models included recent findings, such as age at diagnosis or socioeconomic status, as prognostic factors. The lack of pediatric-specific sources for risk equations and utility/disutility values were additional limitations. Discussion: Economic models designed for assessing interventions in diabetes in pediatric patients should be based on pediatric-specific data and include novel adjuvant glucose-monitoring metrics and latest evidence on prognostic factors (C-peptide, legacy effect, age at diagnosis, socioeconomic status) to provide a more faithful reflection of the disease. Conclusions: Economic models represent useful tools to inform decision making. However, further research assessing the gaps is needed to enhance evidence-based health economic modeling that best represents reality.
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Affiliation(s)
| | | | - Julen Monje
- Health Economics & Outcomes Research Medtronic (Spain)
| | - María Echave
- Pharmacoeconomics & Outcomes Research Iberia (PORIB)
| | | | - María Álvarez
- Health Economics & Outcomes Research Medtronic (Spain)
| | - Isabel Leiva-Gea
- Department of Pediatric Endocrinology Regional University Hospital of Malaga
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Liu Z, Lin B, Chen D, Yang Y, Jiang W, Yang D, Yan J, Yao B, Yang X, Xu W. The related factors affecting the relationship between HbA1c and glucose management indicator in adult T2D patients with good glycemic control. Endocrine 2025; 87:609-618. [PMID: 39472413 DOI: 10.1007/s12020-024-04083-w] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/22/2024] [Accepted: 10/16/2024] [Indexed: 02/11/2025]
Abstract
PURPOSE To explore the relationship between glucose management indicator (GMI) and HbA1c and find the affecting factors in adult T2D patients with good glycemic control. METHODS Adult T2D patients with both HbA1c < 7% and time in range (TIR) > 70% were retrospectively analyzed. A significant difference between GMI and HbA1c was defined as an absolute value of hemoglobin glycation index (|HGI|, HbA1c minus GMI) ≥ 0.5%. Factors associated with high |HGI| were determined by logistic regression analysis. The performance of possible factors in predicting high |HGI| was verified by ROC curve analysis. And the linear relationship between GMI and HbA1c was also investigated. RESULTS Of all the 94 patients (median HbA1c 6.18%, mean GMI 6.34%) included, 28.72% had an |HGI | ≥ 0.5% and only 15.96% had an |HGI | < 0.1%. Standard deviation of blood glucose (SDBG), a glycemic variability index, affected |HGI| (OR = 3.980, P = 0.001), and showed the best performance in predicting high |HGI| (AUC = 0.712, cutoff value = 1.63 mmol/L, P = 0.001). HbA1c was linearly correlated with GMI (β = 0.295, P = 0.004). Their correlation weakened after further adjusting for SDBG (β = 0.232, P = 0.012). Linear correlation between them was closer in patients with smaller SDBG ( < 1.63 mmol/L) than those with larger SDBG (P = 0.004). CONCLUSIONS Even in adult T2D patients with good glycemic control, the discrepancy between GMI and HbA1c existed. Their relationship was affected by glycemic variability. SDBG mainly accounted for this consequence. TRIAL REGISTRATION Chinese clinical trial registry ( www.chictr.org.cn ), ChiCTR2000034884, 2020-07-23.
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Affiliation(s)
- Zhigu Liu
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Beisi Lin
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Danrui Chen
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Yanling Yang
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Wei Jiang
- Department of General Practice, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Daizhi Yang
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Jinhua Yan
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Bin Yao
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China
| | - Xubin Yang
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
| | - Wen Xu
- Department of Endocrinology and Metabolism, Guangdong Provincial Key Laboratory of Diabetology, Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, China.
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Aljohani RA, Altaib HN, Kofi MA. The Use of Freestyle Libre Glucose Monitoring System and Diabetes Treatment Progression in Type 2 Diabetes Mellitus: A Retrospective Cohort Study in Saudi Arabia. Cureus 2025; 17:e79705. [PMID: 40161060 PMCID: PMC11952678 DOI: 10.7759/cureus.79705] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 02/26/2025] [Indexed: 04/02/2025] Open
Abstract
Background Type 2 diabetes mellitus (T2DM) is a prevalent chronic metabolic disease in Saudi Arabia, with a prevalence rate of approximately 25%. Traditional blood glucose monitoring methods, such as finger stick tests, provide limited insights into blood glucose measurements and fluctuations contributing to clinical inertia. The advent of continuous glucose monitoring (CGM) systems, such as the FreeStyle Libre glucose monitoring system, has transformed diabetes management by offering comprehensive exposure of glucose data to healthcare providers. Objective This study aims to evaluate the impact of the FreeStyle Libre glucose monitoring system on diabetes management intensification and treatment progression provided by healthcare specialists among T2DM patients in primary healthcare settings in Riyadh, Saudi Arabia. Methods An observational, retrospective, 24-week, two-arm study was conducted at Prince Sultan Military Medical City. The study involved 188 T2DM patients who were either using standard capillary glucose monitoring or transitioned to the FreeStyle Libre system, and it was based on clinical discretion rather than randomization. The primary outcomes were to evaluate the effect of FreeStyle Libre on treatment intensification provided by healthcare providers and changes in HbA1c levels. Data analysis included descriptive statistics and hypothesis testing using R software. Results Participants using the FreeStyle Libre glucose monitoring system experienced higher rates of medication intensification, and the use of insulin correction doses, and a significant reduction in median HbA1c levels was observed at three months (9.19% vs. 9.6%, p=0.047). However, at six months, the median HbA1c further reduced to 9.07%, though the difference between groups was not statistically significant. Despite these improvements, healthcare provider visits due to hyperglycemia were higher in the FreeStyle Libre group (p<0.001). There were no significant differences in hypoglycemia-related visits between the two groups (p=0.09). Conclusion The FreeStyle Libre glucose monitoring system was associated with increased treatment intensification and a significant reduction in HbA1c at three months compared to standard glucometers. However, by six months, the reduction in HbA1c was no longer statistically significant between groups. The increased healthcare provider visits in the FreeStyle Libre group may be attributed to heightened glucose monitoring awareness rather than the true worsening of hyperglycemia. While CGM offers advantages in diabetes management, its impact on long-term glycemic control remains uncertain. Further research is needed to confirm these findings, assess patient adherence, and evaluate the long-term effectiveness of continuous glucose monitoring in diabetes care.
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Affiliation(s)
- Raed A Aljohani
- Family Medicine, Prince Sultan Military Medical City, Riyadh, SAU
| | - Hanan N Altaib
- Family Medicine, Prince Sultan Military Medical City, Riyadh, SAU
| | - Mostafa A Kofi
- Research Center, Prince Sultan Military Medical City, Riyadh, SAU
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Tauschmann M, Cardona-Hernandez R, DeSalvo DJ, Hood K, Laptev DN, Lindholm Olinder A, Wheeler BJ, Smart CE. International Society for Pediatric and Adolescent Diabetes Clinical Practice Consensus Guidelines 2024 Diabetes Technologies: Glucose Monitoring. Horm Res Paediatr 2025; 97:615-635. [PMID: 39884260 PMCID: PMC11854985 DOI: 10.1159/000543156] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/13/2024] [Accepted: 12/04/2024] [Indexed: 02/01/2025] Open
Abstract
The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents. The International Society for Pediatric and Adolescent Diabetes (ISPAD) guidelines represent a rich repository that serves as the only comprehensive set of clinical recommendations for children, adolescents, and young adults living with diabetes worldwide. This chapter builds on the 2022 ISPAD guidelines, and summarizes recent advances in the technology behind glucose monitoring, and its role in glucose-responsive integrated technology that is feasible with the use of automated insulin delivery (AID) systems in children and adolescents.
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Affiliation(s)
- Martin Tauschmann
- Department of Pediatrics and Adolescent Medicine, Medical University of Vienna, Vienna, Austria
| | | | - Daniel J DeSalvo
- Baylor College of Medicine, Texas Children's Hospital, Houston, Texas, USA
| | - Korey Hood
- Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California, USA
| | - Dmitry N Laptev
- Department of Pediatric Endocrinology, Endocrinology Research Center, Moscow, Russian Federation
| | - Anna Lindholm Olinder
- Department of Clinical Science and Education, Södersjukhuset, Karolinska Institute, Stockholm, Sweden
- Sachs' Children and Youths Hospital, Södersjukhuset, Stockholm, Sweden
| | - Benjamin J Wheeler
- Department of Women's and Children's Health, University of Otago, Dunedin, New Zealand
- Paediatrics, Health New Zealand - Southern, Dunedin, New Zealand
| | - Carmel E Smart
- Department of Paediatric Endocrinology and Diabetes, John Hunter Children's Hospital, Newcastle, New South Wales, Australia
- School of Health Sciences, University of Newcastle, Newcastle, New South Wales, Australia
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Wu Y, Zhang B, Ma X, Yu P, Zhou S, Wang X. Novel indicator of microvascular complications in patients with type 2 diabetes mellitus and shortened erythrocyte lifespan: a multicenter cross-sectional analysis. Diabetol Metab Syndr 2025; 17:26. [PMID: 39844294 PMCID: PMC11752720 DOI: 10.1186/s13098-025-01591-1] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/10/2024] [Accepted: 01/11/2025] [Indexed: 01/24/2025] Open
Abstract
INTRODUCTION In this study, we assessed whether the ratio of glucose management index (GMI) to glycated albumin (GA) was linked to microvascular complications in patients with type 2 diabetes mellitus (T2DM) who also possessed a shortened erythrocyte lifespan. METHODS This study encompassed individuals from the Tianjin Diabetic Retinopathy Screening Cohort who completed continuous glucose monitoring and had an erythrocyte lifespan of under 90 days. Differences in GMI/GA were compared between the T2DM patients with or without microvascular complications, including diabetic kidney disease (DKD) and diabetic retinopathy (DR). The relationship between GMI/GA and microvascular complications (DKD and/or DR) was assessed by dividing GMI/GA into three groups based on tertiles. RESULTS Our study comprised 140 participants with T2DM (62 men and 78 women, with a median age of 67 years) with a median DM duration of 9.68 years, a mean glycated hemoglobin A1c (HbA1c) value of 7.10%, and a median GA value of 16.10%. As expected, the lower GMI/GA group exhibited higher HbA1c and GA (P < 0.001) with similar mean glucose levels (P = 0.099). GMI/GA values were significantly higher in participants without microvascular complications than in those with microvascular complications, including DKD and/or DR (P < 0.05). After adjusting for confounders, the lowest GMI/GA group (T1) had a 3.601-fold increased risk of microvascular complications (95% CI, 1.364-9.508, P = 0.010) and a 3.830-fold increased risk of DKD, specifically (95% CI, 1.364-12.222, P = 0.023) relative to the highest group (T3). CONCLUSION GMI/GA serves as a novel risk indicator for microvascular complications in T2DM, independent of HbA1c.
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Affiliation(s)
- Yunqi Wu
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China
| | - Binshan Zhang
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China
| | - Xin Ma
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China
| | - Pei Yu
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China.
- Department of Nephrology & Blood Purification Center, The Second Hospital of Tianjin Medical University, Tianjin, 300211, China.
| | - Saijun Zhou
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China.
| | - Xinli Wang
- NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin, 300134, China.
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Gera S, Rearson A, Baker G, Douvas JL, Alicea-Trelles N, Gallop RJ, Meighan S, Marks BE. Changes in 90-Day Time in Range Among Youth with Type 1 Diabetes Initiating Different Automated Insulin Delivery Systems. J Clin Endocrinol Metab 2025:dgaf006. [PMID: 39813114 DOI: 10.1210/clinem/dgaf006] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/02/2024] [Revised: 11/20/2024] [Accepted: 01/10/2025] [Indexed: 01/18/2025]
Abstract
OBJECTIVE Glycemic outcomes in youth with type 1 diabetes (T1D) in the United States using the two most common automated insulin delivery (AID) systems, Insulet Omnipod 5 (OP5) and Tandem Control IQ (CIQ), have not been compared. We performed the first head-to-head analysis of changes in glycemic metrics among youth initiating AID. METHODS This single center, retrospective study included youth <21 years with T1D, who started OP5 or CIQ between 1/2020 and 12/2023, and had ≥70% CGM active time. 14-day baseline and 90-day CGM and AID data were obtained. A multiple linear regression model assessed for changes in 90-day time in range (TIR) according to AID system, adjusting for covariates. Sub-analyses were conducted according to baseline TIR categories. RESULTS Among the 428 youth included, there were 214 (50%) in each AID group. OP5 users had a shorter T1D duration (1.6 vs 5.5 years, p<0.001) and were more likely to have transitioned from multiple daily injections (76.1% vs 20.1%, p<0.001). Baseline TIR was similar between groups (OP5 51.6% vs CIQ 53.1%, p=0.70). 90-day TIR increased in both groups (p<0.001), rising by 11.8%-points (95% CI[10.4,13.3]) in OP5 users and 9.8%-points (95% CI[8.3,11.2]) in CIQ users, without any significant between group differences (p=0.08). There were no between group differences in 90-day TIR according to categorical baseline TIR. CONCLUSIONS There are no clinically significant differences in 90-day TIR among youth with T1D initiating the two most commonly used AID systems. Patient preference and shared decision making should continue to guide the selection of AID systems.
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Affiliation(s)
- Sonia Gera
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
| | - Andrew Rearson
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
| | - Greyson Baker
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
| | - Julia L Douvas
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
| | | | - Robert J Gallop
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
- University of Pennsylvania, Philadelphia, PA, 19104
| | - Seema Meighan
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
| | - Brynn E Marks
- Children's Hospital of Philadelphia, Philadelphia, PA, 19104
- University of Pennsylvania, Philadelphia, PA, 19104
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Ajjan RA, Battelino T, Seufert J, Blin P, de Pouvourville G, Vicaut E, Carcaillon-Bentata L, Levrat-Guillen F, Cosson E, Joubert M. Do continuous glucose monitoring (CGM) metrics predict macrovascular and microvascular complications in diabetes? The FACULTY protocol of a retrospective real-world cohort study. BMJ Open 2025; 15:e085961. [PMID: 39779259 PMCID: PMC11749619 DOI: 10.1136/bmjopen-2024-085961] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2024] [Accepted: 11/07/2024] [Indexed: 01/11/2025] Open
Abstract
INTRODUCTION Glycated haemoglobin (HbA1c) is currently the gold standard for assessing glycaemic control in diabetes, given the established relationship with microvascular and macrovascular complications in this condition. However, HbA1c is affected by non-glycaemic factors, while also failing to provide data on hypoglycaemic exposure and glucose variability, which are associated with adverse vascular outcomes. Continuous glucose monitoring (CGM)-derived glucose metrics provide a more comprehensive assessment of glycaemia, but their role in predicting future vascular complications remains unclear. Here, we present the protocol for a real-world cohort study, aiming to establish the relationship between CGM-derived glycaemic metrics and the incidence of macrovascular and/or microvascular complications in people with diabetes. METHODS AND ANALYSIS This cohort study will use data from all CGM new users (FreeStyle Libre system) in France who uploaded their glycaemic values onto the LibreView cloud-based system, linked with data from the French nationwide Système National des Données de Santé claims database. The study is expected to include a minimum of 70 000 individuals with diabetes with a first date of glucose data upload to the LibreView platform after 1 January 2018 and with a 6-year follow-up period. The primary outcomes are the first occurrence of new macrovascular or microvascular complications, analysed as a composite outcome and separately. Secondary outcomes will include all-cause mortality and hospital admissions for any cause. This longitudinal study will provide key data on the relationship between CGM-derived glycaemic metrics and micro/macrovascular complications in diabetes. This will have an impact on routine clinical practice by setting targets for the different glycaemic markers, based on robust outcome data, thus helping to optimise glucose management in diabetes. ETHICS AND DISSEMINATION The study data-collection protocol is approved by the French National Commission for Informatics and Liberties, including approval from the Comité Ethique et Scientifique pour les Recherches, les Etudes et les Evaluations dans le domaine de la Santé. This study complies with French and European regulations, including those relating to the General Data Protection Regulation. This study uses pseudonymous information, not requiring informed consent. Dissemination plans include full publication of the study outcomes in peer-reviewed journal(s) with open access and presentations at national and international diabetes and cardiovascular conferences.
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Affiliation(s)
- Ramzi A Ajjan
- The LIGHT Laboratories, Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
| | - Tadej Battelino
- Department of Endocrinology, Diabetes and Metabolism, University Children's Hospital, University Medical Center Ljubljana and Faculty of Medicine, University of Lubljana, Ljubljana, Slovenia
| | - J Seufert
- Department of Endocrinology and Diabetology, Department of Medicine II, Medical Centre, University of Freiburg, Freiburg, Germany
| | - Patrick Blin
- University of Bordeaux, INSERM CIC-P 1401, Bordeaux PharmacoEpi, Bordeaux, France
| | | | - Eric Vicaut
- Clinical Research Unit, Fernand Vidal Hospital, Paris, France
| | | | | | - Emmanuel Cosson
- Department of Endocrinology-Diabetology-Nutrition, CINFO, Bobigny, France
- UMR U1153 INSERM/U11125 INRA/CNAM/Université Paris 13, Bobigny, France
| | - Michael Joubert
- Diabetes Care Unit, Caen University Hospital, Caen cedex 09, France
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Naiki Y, Itho R, Misaki Y. Discrepancy between levels of HbA1c and continuous glucose monitoring in patients with Fontan circulation. Pediatr Int 2025; 67:e70060. [PMID: 40317831 DOI: 10.1111/ped.70060] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/04/2024] [Revised: 12/09/2024] [Accepted: 02/06/2025] [Indexed: 05/07/2025]
Affiliation(s)
- Yasuhiro Naiki
- Division of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo, Japan
| | - Reiko Itho
- Department of General Pediatrics and Interdisciplinary Medicine, National Center for Child Health and Development, Tokyo, Japan
| | - Yasushi Misaki
- Division of Endocrinology and Metabolism, National Center for Child Health and Development, Tokyo, Japan
- Division of Cardiology, National Center for Child Health and Development, Tokyo, Japan
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Christakis NJ, Gioe M, Gomez R, Felipe D, Soros A, McCarter R, Chalew S. Determination of Glucose-Independent Racial Disparity in HbA1c for Youth With Type 1 Diabetes in the Era of Continuous Glucose Monitoring. J Diabetes Sci Technol 2025; 19:72-79. [PMID: 37700590 PMCID: PMC11688699 DOI: 10.1177/19322968231199113] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 09/14/2023]
Abstract
BACKGROUND The magnitude and importance of higher HbA1c levels not due to mean blood glucose (MBG) in non-Hispanic black (B) versus non-Hispanic white (W) individuals is controversial. We sought to clarify the relationship of HbA1c with glucose data from continuous glucose monitoring (CGM) in a young biracial population. METHODS Glycemic data of 33 B and 85 W, healthy youth with type 1 diabetes (age 14.7 ± 4.8 years, M/F = 51/67, duration of diabetes 5.4 ± 4.7 years) from a factory-calibrated CGM was compared with HbA1c. Hemoglobin glycation index (HGI) = assayed HbA1c - glucose management index (GMI). RESULTS B patients had higher unadjusted levels of HbA1c, MBG, MBGSD, GMI, and HGI than W patients. Percent glucose time in range (TIR) and percent sensor use (PSU) were lower for B patients. Average HbA1c in B patients 8.3% was higher than 7.7% for W (P < .0001) after statistical adjustment for MBG, age, gender, insulin delivery method, and accounting for a race by PSU interaction effect. Higher HbA1c persisted in B patients when TIR was substituted for MBG. Predicted MBG was higher in B patients at any level of PSU. The 95th percentile for HGI was 0.47 in W patients, and 52% of B patients had HGI ≥ 0.5. Time below range was similar for both. CONCLUSIONS Young B patients have clinically relevant higher average HbA1c at any given level of MBG or TIR than W patients, which may pose an additional risk for diabetes complications development. HGI ≥ 0.5 may be an easy way to identify high-risk patients.
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Affiliation(s)
- Nicholas J. Christakis
- School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Marcella Gioe
- Endocrinology and Diabetes, Children’s Hospital of New Orleans, New Orleans, LA, USA
| | - Ricardo Gomez
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Dania Felipe
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Arlette Soros
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
| | - Robert McCarter
- Bioinformatics, Biostatistics and Epidemiology, Children’s National Medical Center, George Washington University, Washington, DC, USA
| | - Stuart Chalew
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, School of Medicine, Louisiana State University Health Sciences Center, New Orleans, LA, USA
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Castorino K, Durnwald C, Ehrenberg S, Ehrhardt N, Isaacs D, Levy CJ, Valent AM. Practical Considerations for Using Continuous Glucose Monitoring in Patients with Gestational Diabetes Mellitus. J Womens Health (Larchmt) 2025; 34:10-20. [PMID: 39378174 DOI: 10.1089/jwh.2023.0864] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/10/2024] Open
Abstract
Gestational diabetes mellitus (GDM) is the most prevalent metabolic complication during pregnancy. GDM is associated with adverse perinatal, neonatal, and long-term health consequences. Studies have demonstrated that the use of continuous glucose monitoring (CGM) reduces the incidence of maternal and neonatal complications in pregnant women with type 1 diabetes. Although the use of CGM in GDM has not been well studied, a growing body of evidence is showing potential benefits in the GDM population. This article discusses the advantages and challenges of CGM and provides practical guidelines for using this technology in the GDM population.
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Affiliation(s)
| | - Celeste Durnwald
- Department of Obstetrics and Gynecology, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA
| | - Stacey Ehrenberg
- Department of Obstetrics and Gynecology Institute, Cleveland Clinic Foundation, Cleveland, Ohio, USA
| | - Nicole Ehrhardt
- Division of Endocrinology, Diabetes and Metabolism, University of Washington Diabetes Institute, Seattle, Washington, USA
| | - Dianna Isaacs
- Cleveland Clinic Endocrinology & Metabolism Institute, Cleveland, Ohio, USA
| | - Carol J Levy
- Icahn School of Medicine at Mount Sinai, New York, New York, USA
| | - Amy M Valent
- Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon, USA
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Cruz P, McKee AM, Chiang HH, McGill JB, Hirsch IB, Ringenberg K, Wildes TS. Perioperative Care of Patients Using Wearable Diabetes Devices. Anesth Analg 2025; 140:2-12. [PMID: 38913575 DOI: 10.1213/ane.0000000000007115] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 06/26/2024]
Abstract
The increasing prevalence of diabetes mellitus has been accompanied by a rapid expansion in wearable continuous glucose monitoring (CGM) devices and insulin pumps. Systems combining these components in a "closed loop," where interstitial glucose measurement guides automated insulin delivery (AID, or closed loop) based on sophisticated algorithms, are increasingly common. While these devices' efficacy in achieving near-normoglycemia is contributing to increasing usage among patients with diabetes, the management of these patients in operative and procedural environments remains understudied with limited published guidance available, particularly regarding AID systems. With their growing prevalence, practical management advice is needed for their utilization, or for the rational temporary substitution of alternative diabetes monitoring and treatments, during surgical care. CGM devices monitor interstitial glucose in real time; however, there are potential limitations to use and accuracy in the perioperative period, and, at the present time, their use should not replace regular point-of-care glucose monitoring. Avoiding perioperative removal of CGMs when possible is important, as removal of these prescribed devices can result in prolonged interruptions in CGM-informed treatments during and after procedures, particularly AID system use. Standalone insulin pumps provide continuous subcutaneous insulin delivery without automated adjustments for glucose concentrations and can be continued during some procedures. The safe intraoperative use of AID devices in their hybrid closed-loop mode (AID mode) requires the CGM component of the system to continue to communicate valid blood glucose data, and thus introduces the additional need to ensure this portion of the system is functioning appropriately to enable intraprocedural use. AID devices revert to non-AID insulin therapy modes when paired CGMs are disconnected or when the closed-loop mode is intentionally disabled. For patients using insulin pumps, we describe procedural factors that may compromise CGM, insulin pump, and AID use, necessitating a proactive transition to an alternative insulin regimen. Procedure duration and invasiveness is an important factor as longer procedures increase the risk of stress hyperglycemia, tissue malperfusion, and device malfunction. Whether insulin pumps should be continued through procedures, or substituted by alternative insulin delivery methods, is a complex decision that requires all parties to understand potential risks and contingency plans relating to patient and procedural factors. Currently available CGMs and insulin pumps are reviewed, and practical recommendations for safe glycemic management during the phases of perioperative care are provided.
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Affiliation(s)
- Paulina Cruz
- From the Division of Endocrinology, Metabolism & Lipid Research, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri
| | - Alexis M McKee
- From the Division of Endocrinology, Metabolism & Lipid Research, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri
| | - Hou-Hsien Chiang
- Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, University of Washington School of Medicine, University of Washington, Seattle, Washington
| | - Janet B McGill
- From the Division of Endocrinology, Metabolism & Lipid Research, Department of Medicine, Washington University in St Louis School of Medicine, St Louis, Missouri
| | - Irl B Hirsch
- Division of Metabolism, Endocrinology and Nutrition, Department of Medicine, University of Washington School of Medicine, University of Washington, Seattle, Washington
| | - Kyle Ringenberg
- Department of Anesthesiology, University of Nebraska Medical Center, Omaha, Nebraska
| | - Troy S Wildes
- Department of Anesthesiology, University of Nebraska Medical Center, Omaha, Nebraska
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Alqutub ST, Aljehani F. Impact of the KARAZ platform's behavioral interventions and incentives on diabetic glycemic control in Saudi Arabia. Digit Health 2025; 11:20552076251325987. [PMID: 40123886 PMCID: PMC11930475 DOI: 10.1177/20552076251325987] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2024] [Accepted: 02/18/2025] [Indexed: 03/25/2025] Open
Abstract
Introduction The glucose management indicator (GMI) and time-in-range (TIR) are important glycemic parameters calculated from continuous glucose monitoring (CGM) values. KARAZ, a hybrid Internet of things-artificial intelligence platform, was developed in Saudi Arabia to help manage diabetes mellitus. The complex nature of self-care and behavior changes associated with diabetes mellitus requires breaking large behaviors into achievable ones and related incentives. Aim This study explored how tiny habits as a behavioral intervention and incentive system affect glycemic control among KARAZ Platform users with diabetes mellitus in various age groups in Saudi Arabia. Methods This retrospective study included KARAZ Platform users and analyzed the effects of behavioral interventions and incentives on GMI and TIR as glycemic control parameters. Results Of 296 active users, 118 (40%) and 148 (50%) maintained a desirable TIR and GMI, respectively. Adult females aged ≥ 26 years who consistently followed tiny habits and behavior changes exhibited a significant reduction in the GMI (5%). Intrinsic motivation through behavioral modification was more effective than external incentives for maintaining glucose control. Conclusion The findings highlight how behavioral interventions can impact GMI, suggesting their effectiveness in promoting better health behaviors and improving glycemic control in the Saudi Arabian context. Further research should investigate how these habits and behaviors can be maintained sustainably without relying on external incentives. Recommendations discussed how children with Type 1 diabetes mellitus would benefit from CGM connection to KARAZ Platform iteration and the integration of a comprehensive diabetes care program within the Saudi health system.
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Affiliation(s)
- Sulafa T Alqutub
- Department of Family and Community Medicine, College of Medicine, University of Jeddah, Jeddah, Kingdom of Saudi Arabia
| | - Faisal Aljehani
- Department of Internal Medicine, College of Medicine, University of Jeddah, Jeddah, Kingdom of Saudi Arabia
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Abadi RNS, Jazinaki MS, Bahari H, Rashidmayvan M, Amini MR, Aliakbarian M, Khodashahi R, Malekahmadi M. Impact of Melatonin Supplementation on Glycemic Parameters in Patients with Type 2 Diabetes: A Systematic Review and Meta-analysis. Curr Pharm Des 2025; 31:645-657. [PMID: 39428939 DOI: 10.2174/0113816128345623241004080849] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/20/2024] [Revised: 08/30/2024] [Accepted: 09/06/2024] [Indexed: 10/22/2024]
Abstract
BACKGROUND Several previous studies indicated that melatonin supplementation may positively affect glycemic control in patients with diabetes. However, research on the influence of melatonin supplementation on glycemic parameters remains inconclusive. Therefore, this study aimed to assess the impacts of melatonin supplementation on glycemic parameters in type 2 diabetes by conducting a meta-analysis. METHODS PubMed/Medline, Scopus, and Web of Science were comprehensively searched until July 2024 to find eligible randomized clinical trials (RCTs). The overall effect sizes were estimated by using the randomeffect model and presented as weighted mean differences (WMD) with a 95% confidence interval (CI). Furthermore, the heterogeneity among the included trials was assessed by performing the Cochran Q test and interpreted based on the I² statistic. RESULTS Of the 1361 papers, eight eligible RCTs were included in this meta-analysis. Our findings indicated that melatonin supplementation significantly decreased fasting blood glucose (WMD = -12.65 mg/dl; 95% CI: -20.38, -4.92; P = 0.001), insulin (WMD = -2.30 μU/ml; 95% CI: -3.20, -1.40; P < 0.001), hemoglobin A1c (WMD = -0.79 %; 95% CI: -1.28, -0.29; P = 0.002), and HOMA-IR (WMD, -0.83; 95% CI: -1.59 to - 0.07; P = 0.03). CONCLUSION According to the results of the current meta-analysis, persons with type 2 diabetes who supplement with melatonin had improved glycemic control. It looks that supplementing with melatonin at a dose exceeding 6 mg daily for over a period of 12 weeks may be more successful than other forms of intervention. Nevertheless, further research with larger sample sizes is necessary to draw definitive conclusions.
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Affiliation(s)
- Reza Nejad Shahrokh Abadi
- Clinical Research Development Unit, Faculty of Medicine, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
| | | | - Hossein Bahari
- Transplant Research Center, Clinical Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Mohammad Rashidmayvan
- Department of Nutrition, Food Sciences and Clinical Biochemistry, Social Determinants of Health Research Center, School of Medicine, Gonabad University of Medical Science, Gonabad, Iran
| | - Mohammad Reza Amini
- Student Research Committee, Department of Clinical Nutrition and Dietetics, Faculty of Nutrition Sciences and Food Technology, National Nutrition & Food Technology Research Institute, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- Nutrition and Food Security Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
| | - Mohsen Aliakbarian
- Transplant Research Center, Clinical Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Rozita Khodashahi
- Transplant Research Center, Clinical Research Institute, Mashhad University of Medical Sciences, Mashhad, Iran
- Clinical Research Development Unit, Faculty of Medicine, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
- Department of Infectious Diseases and Tropical Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
| | - Mahsa Malekahmadi
- Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran
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Lee MY, Ritter V, Shaw B, Ferstad JO, Johari R, Scheinker D, Bishop F, Desai M, Maahs DM, Prahalad P. Addressing Disparities Using Continuous Glucose Monitors and Remote Patient Monitoring for Youth With Type 1 Diabetes. J Diabetes Sci Technol 2024:19322968241305612. [PMID: 39711469 PMCID: PMC11664559 DOI: 10.1177/19322968241305612] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/24/2024]
Abstract
BACKGROUND Youth with type 1 diabetes (T1D) and public insurance have lower diabetes technology use. This pilot study assessed the feasibility of a program to support continuous glucose monitor (CGM) use with remote patient monitoring (RPM) to improve glycemia for youth with established T1D and public insurance. METHODS From August 2020 to June 2023, we provided CGM with RPM support via patient portal messaging for youth with established T1D on public insurance with challenges obtaining consistent CGM supplies. We prospectively collected hemoglobin A1c (HbA1c), standard CGM metrics, and diabetes technology use over 12 months. RESULTS The cohort included 91 youths with median age at enrollment 14.7 years, duration of diabetes 4.4 years, 33% non-English speakers, and 44% Hispanic. Continuous glucose monitor data were consistently available (≥70%) in 23% of the participants. For the 64% of participants with paired HbA1c values at enrollment and study end, the median HbA1c decreased from 9.8% to 9.0% (P < .001). Insulin pump users increased from 31 to 48 and automated insulin delivery users increased from 11 to 38. CONCLUSIONS We established a program to support CGM use in youth with T1D and barriers to consistent CGM supplies, offering lessons for other clinics to address disparities with team-based, algorithm-enabled, remote T1D care. This real-world pilot and feasibility study noted challenges with low levels of protocol adherence and obtaining complete data in this cohort. Future iterations of the program should explore RPM communication methods that better align with this population's preferences to increase participant engagement.
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Affiliation(s)
- Ming Yeh Lee
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA
| | - Victor Ritter
- Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA, USA
| | - Blake Shaw
- Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA, USA
| | - Johannes O. Ferstad
- Department of Management Science and Engineering, Stanford University, Stanford, CA, USA
| | - Ramesh Johari
- Department of Management Science and Engineering, Stanford University, Stanford, CA, USA
| | - David Scheinker
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA
- Department of Management Science and Engineering, Stanford University, Stanford, CA, USA
- Stanford Diabetes Research Center, Stanford University, Stanford, CA, USA
- Clinical Excellence Research Center, Stanford University, Stanford, CA, USA
| | - Franziska Bishop
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA
| | - Manisha Desai
- Division of Biomedical Informatics Research, Department of Medicine, Stanford University, Stanford, CA, USA
| | - David M. Maahs
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA
- Stanford Diabetes Research Center, Stanford University, Stanford, CA, USA
- Department of Epidemiology and Population Health, Stanford University, Stanford, CA, USA
| | - Priya Prahalad
- Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Stanford University, Stanford, CA, USA
- Stanford Diabetes Research Center, Stanford University, Stanford, CA, USA
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Asgharzadeh A, Patel M, Connock M, Damery S, Ghosh I, Jordan M, Freeman K, Brown A, Court R, Baldwin S, Ogunlayi F, Stinton C, Cummins E, Al-Khudairy L. Hybrid closed-loop systems for managing blood glucose levels in type 1 diabetes: a systematic review and economic modelling. Health Technol Assess 2024; 28:1-190. [PMID: 39673446 DOI: 10.3310/jypl3536] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2024] Open
Abstract
Background Hybrid closed-loop systems are a new class of technology to manage type 1 diabetes mellitus. The system includes a combination of real-time continuous glucose monitoring from a continuous glucose monitoring device and a control algorithm to direct insulin delivery through an insulin pump. Evidence suggests that such technologies have the potential to improve the lives of people with type 1 diabetes mellitus and their families. Aim The aim of this appraisal was to assess the clinical effectiveness and cost-effectiveness of hybrid closed-loop systems for managing glucose in people who have type 1 diabetes mellitus and are having difficulty managing their condition despite prior use of at least one of the following technologies: continuous subcutaneous insulin infusion, real-time continuous glucose monitoring or flash glucose monitoring (intermittently scanned continuous glucose monitoring). Methods A systematic review of clinical effectiveness and cost-effectiveness evidence following predefined inclusion criteria informed by the aim of this review. An independent economic assessment using iQVIA CDM to model cost-effectiveness. Results The clinical evidence identified 12 randomised controlled trials that compared hybrid closed loop with continuous subcutaneous insulin infusion + continuous glucose monitoring. Hybrid closed-loop arm of randomised controlled trials achieved improvement in glycated haemoglobin per cent [hybrid closed loop decreased glycated haemoglobin per cent by 0.28 (95% confidence interval -0.34 to -0.21), increased per cent of time in range (between 3.9 and 10.0 mmol/l) with a MD of 8.6 (95% confidence interval 7.03 to 10.22), and significantly decreased time in range (per cent above 10.0 mmol/l) with a MD of -7.2 (95% confidence interval -8.89 to -5.51), but did not significantly affect per cent of time below range (< 3.9 mmol/l)]. Comparator arms showed improvements, but these were smaller than in the hybrid closed-loop arm. Outcomes were superior in the hybrid closed-loop arm compared with the comparator arm. The cost-effectiveness search identified six studies that were included in the systematic review. Studies reported subjective cost-effectiveness that was influenced by the willingness-to-pay thresholds. Economic evaluation showed that the published model validation papers suggest that an earlier version of the iQVIA CDM tended to overestimate the incidences of the complications of diabetes, this being particularly important for severe visual loss and end-stage renal disease. Overall survival's medium-term modelling appeared good, but there was uncertainty about its longer-term modelling. Costs provided by the National Health Service Supply Chain suggest that hybrid closed loop is around an annual average of £1500 more expensive than continuous subcutaneous insulin infusion + continuous glucose monitoring, this being a pooled comparator of 90% continuous subcutaneous insulin infusion + intermittently scanned continuous glucose monitoring and 10% continuous subcutaneous insulin infusion + real-time continuous glucose monitoring due to clinical effectiveness estimates not being differentiated by continuous glucose monitoring type. This net cost may increase by around a further £500 for some systems. The Evidence Assessment Group base case applies the estimate of -0.29% glycated haemoglobin for hybrid closed loop relative to continuous subcutaneous insulin infusion + continuous glucose monitoring. There was no direct evidence of an effect on symptomatic or severe hypoglycaemia events, and therefore the Evidence Assessment Group does not include these in its base case. The change in glycated haemoglobin results in a gain in undiscounted life expectancy of 0.458 years and a gain of 0.160 quality-adjusted life-years. Net lifetime treatment costs are £31,185, with reduced complications leading to a net total cost of £28,628. The cost-effectiveness estimate is £179,000 per quality-adjusted life-year. Conclusions Randomised controlled trials of hybrid closed-loop interventions in comparison with continuous subcutaneous insulin infusion + continuous glucose monitoring achieved a statistically significant improvement in glycated haemoglobin per cent in time in range between 3.9 and 10 mmol/l, and in hyperglycaemic levels. Study registration This study is registered as PROSPERO CRD42021248512. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Evidence Synthesis programme (NIHR award ref: NIHR133547) and is published in full in Health Technology Assessment; Vol. 28, No. 80. See the NIHR Funding and Awards website for further award information.
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Affiliation(s)
- Asra Asgharzadeh
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Mubarak Patel
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Martin Connock
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Sara Damery
- Murray Learning Centre, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK
| | - Iman Ghosh
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Mary Jordan
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Karoline Freeman
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Anna Brown
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Rachel Court
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Sharin Baldwin
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Fatai Ogunlayi
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | - Chris Stinton
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
| | | | - Lena Al-Khudairy
- Warwick Evidence, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK
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Oliver N, Reddy M, Leelarathna L. Continuous glucose sensor accuracy: beyond the headline metric. Lancet Diabetes Endocrinol 2024; 12:934-938. [PMID: 39419044 DOI: 10.1016/s2213-8587(24)00245-6] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/07/2024] [Revised: 07/31/2024] [Accepted: 07/31/2024] [Indexed: 10/19/2024]
Abstract
The promotion of continuous glucose monitoring (CGM) to standard of care for type 1 diabetes and insulin-treated type 2 diabetes reflects a robust and wide evidence base for the technology's effectiveness supported by real-world efficacy data. Multiple CGM devices are available worldwide and are marketed, in part, based on accuracy data. In this Viewpoint, we argue that accuracy metrics are no longer a point of difference between CGM devices as almost all exceed an acceptable threshold. We also argue that domains of standardisation, clinical outcomes, and sustainability should now be given primacy as CGM devices seek to be implemented for new indications. These domains are key for the success of the next generation of CGM devices. Additionally, we discuss the need to address inequalities in accessing clinically impactful technologies.
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Affiliation(s)
- Nick Oliver
- Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK.
| | - Monika Reddy
- Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK
| | - Lala Leelarathna
- Department of Metabolism, Digestion and Reproduction, Faculty of Medicine, Imperial College London, London, UK
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