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Søholm U, Broadley M, Zaremba N, Divilly P, Baumann PM, Mahmoudi Z, Martine-Edith G, Mader JK, Cigler M, Brøsen JMB, Vaag A, Heller S, Pedersen-Bjergaard U, McCrimmon RJ, Renard E, Evans M, de Galan B, Abbink E, Amiel SA, Hendrieckx C, Speight J, Choudhary P, Pouwer F. The impact of hypoglycaemia on daily functioning among adults with diabetes: a prospective observational study using the Hypo-METRICS app. Diabetologia 2024; 67:2160-2174. [PMID: 39080044 PMCID: PMC11447150 DOI: 10.1007/s00125-024-06233-1] [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: 02/22/2024] [Accepted: 04/29/2024] [Indexed: 10/03/2024]
Abstract
AIMS/HYPOTHESIS The aim of this work was to examine the impact of hypoglycaemia on daily functioning among adults with type 1 diabetes or insulin-treated type 2 diabetes, using the novel Hypo-METRICS app. METHODS For 70 consecutive days, 594 adults (type 1 diabetes, n=274; type 2 diabetes, n=320) completed brief morning and evening Hypo-METRICS 'check-ins' about their experienced hypoglycaemia and daily functioning. Participants wore a blinded glucose sensor (i.e. data unavailable to the participants) for the study duration. Days and nights with or without person-reported hypoglycaemia (PRH) and/or sensor-detected hypoglycaemia (SDH) were compared using multilevel regression models. RESULTS Participants submitted a mean ± SD of 86.3±12.5% morning and 90.8±10.7% evening check-ins. For both types of diabetes, SDH alone had no significant associations with the changes in daily functioning scores. However, daytime and night-time PRH (with or without SDH) were significantly associated with worsening of energy levels, mood, cognitive functioning, negative affect and fear of hypoglycaemia later that day or while asleep. In addition, night-time PRH (with or without SDH) was significantly associated with worsening of sleep quality (type 1 and type 2 diabetes) and memory (type 2 diabetes). Further, daytime PRH (with or without SDH), was associated with worsening of fear of hyperglycaemia while asleep (type 1 diabetes), memory (type 1 and type 2 diabetes) and social functioning (type 2 diabetes). CONCLUSIONS/INTERPRETATION This prospective, real-world study reveals impact on several domains of daily functioning following PRH but not following SDH alone. These data suggest that the observed negative impact is mainly driven by subjective awareness of hypoglycaemia (i.e. PRH), through either symptoms or sensor alerts/readings and/or the need to take action to prevent or treat episodes.
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Affiliation(s)
- Uffe Søholm
- Medical & Science, Patient Focused Drug Development, Novo Nordisk A/S, Søborg, Denmark.
- Department of Psychology, University of Southern Denmark, Odense, Denmark.
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK.
| | - Melanie Broadley
- Department of Psychology, University of Southern Denmark, Odense, Denmark
| | - Natalie Zaremba
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
| | - Patrick Divilly
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
| | | | - Zeinab Mahmoudi
- Data Science, Department of Pharmacometrics, Novo Nordisk A/S, Søborg, Denmark
| | - Gilberte Martine-Edith
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
| | - Julia K Mader
- Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | - Monika Cigler
- Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria
| | | | - Allan Vaag
- Steno Diabetes Center Copenhagen, Herlev, Denmark
- Lund University Diabetes Center, Lund University, Malmö, Sweden
- Department of Endocrinology, Skåne University Hospital, Malmö, Sweden
| | - Simon Heller
- Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
| | - Ulrik Pedersen-Bjergaard
- Department of Endocrinology and Nephrology, Nordsjællands Hospital Hillerød, Hillerød, Denmark
- Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
| | - Rory J McCrimmon
- Systems Medicine, School of Medicine, University of Dundee, Dundee, UK
| | - Eric Renard
- Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France
- Institute of Functional Genomics, University of Montpellier, CNRS, Inserm, Montpellier, France
| | - Mark Evans
- Welcome MRC Institute of Metabolic Science and Department of Medicine, University of Cambridge, Cambridge, UK
| | - Bastiaan de Galan
- Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands
- Department of Internal Medicine, Division of Endocrinology and Metabolic Disease, Maastricht University Medical Centre, Maastricht, the Netherlands
- CARIM School for Cardiovascular Diseases, Maastricht University, Maastricht, the Netherlands
| | - Evertine Abbink
- Department of Internal Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands
| | - Stephanie A Amiel
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
| | - Christel Hendrieckx
- Institute for Health Transformation, School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, VIC, Australia
| | - Jane Speight
- Department of Psychology, University of Southern Denmark, Odense, Denmark
- Institute for Health Transformation, School of Psychology, Deakin University, Geelong, VIC, Australia
- The Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Carlton, VIC, Australia
| | - Pratik Choudhary
- Department of Diabetes, School of Cardiovascular and Metabolic Medicine and Sciences, Faculty of Life Sciences and Medicine, King's College London, London, UK
- Diabetes Research Centre, University of Leicester, Leicester, UK
| | - Frans Pouwer
- Department of Psychology, University of Southern Denmark, Odense, Denmark
- Steno Diabetes Center Odense (SDCO), Odense, Denmark
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Alsahli MA, Alalwan A, Aburisheh KH, Alarifi FF, Alshaya HM, Alkholaif AF, Shadid AM, Alsahli SA, Alsahly AA, Alkhalifah MK. Assessing satisfaction, quality of life, and HbA1c changes in type 1 diabetes patients who are using freestyle libre glucose monitoring. J Family Med Prim Care 2024; 13:2367-2374. [PMID: 39027821 PMCID: PMC11254085 DOI: 10.4103/jfmpc.jfmpc_1630_23] [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: 10/04/2023] [Revised: 12/21/2023] [Accepted: 01/02/2024] [Indexed: 07/20/2024] Open
Abstract
Introduction Type 1 diabetes mellitus (T1DM) is a chronic auto-immune disease in which loss of pancreatic islet β-cells leads to the deficiency of insulin in the body thus resulting in enhanced blood sugar levels. Effective blood glucose monitoring is crucial in T1DM management to prevent complications, particularly hypoglycemia. Method The study adopted a cross-sectional survey to assess satisfaction and quality of life among T1DM patients using the freestyle libre continuous glucose monitoring (FSL-CGM), and a retrospective cohort study design to evaluate changes in HbA1c over a year. Result The study involved 98 Saudi subjects, with 46.9% (n = 46) being male. The results indicated a high level of user satisfaction, with more than 85% of the participants responding positively, yielding a total satisfaction score of 30.86. User satisfaction with FSL-CGM was found to be significantly associated with the level of education. The use of FSL-CGM was also found to significantly improve the patients' quality of life. However, the levels of HbA1c had an impact on both satisfaction and quality of life. Before using the FSL-CGM system, the mean HbA1c was 9.83%, which significantly decreased to 8.63% after using the system (P-value <0.001). Conclusion The study's findings align with previous literature on satisfaction and quality of life, but there are conflicting results regarding the reduction of HbA1c levels using FSL-CGM. Given the limited sample size, future research could explore the topic more comprehensively, potentially utilizing a longitudinal study design to better measure changes in HbA1c level.
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Affiliation(s)
| | - Abdulaziz Alalwan
- University Family Medicine Center, Department of Family and Community Medicine, College of Medicine, King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia
| | - Khaled H. Aburisheh
- University Diabetes Center, King Saud University Medical City, King Saud University, Riyadh, Saudi Arabia
| | | | | | | | | | - Saud A. Alsahli
- College of Medicine, Al-Imam Mohammad Ibn Saud Islamic University, Riyadh, Saudi Arabia
| | - Abdullaziz A. Alsahly
- College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia
| | - Mohammed K. Alkhalifah
- University Family Medicine Center, Department of Family and Community Medicine, College of Medicine, King Saud University Medical City, Riyadh, Kingdom of Saudi Arabia
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Battelino T, Brosius F, Ceriello A, Cosentino F, Green J, Kellerer M, Koob S, Kosiborod M, Lalic N, Marx N, Nedungadi TP, Rydén L, Rodbard HW, Ji L, Sheu WHH, Standl E, Parkin CG, Schnell O. Guideline Development for Medical Device Technology: Issues for Consideration. J Diabetes Sci Technol 2023; 17:1698-1710. [PMID: 35531901 PMCID: PMC10658688 DOI: 10.1177/19322968221093355] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.
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Affiliation(s)
- Tadej Battelino
- University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia
| | - Frank Brosius
- University of Arizona College of Medicine–Tucson, AZ, USA
| | | | - Francesco Cosentino
- Cardiology Unit, Department of Medicine, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden
| | - Jennifer Green
- Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA
| | | | | | - Mikhail Kosiborod
- Saint Luke’s Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA
- The George Institute for Global Health, University of New South Wales, Sydney, Australia
| | - Nebojsa Lalic
- Clinic for Endocrinology, Diabetes and Metabolic Diseases, University Clinical Center of Serbia, University of Belgrade, Belgrade, Serbia
| | - Nikolaus Marx
- Department of Internal Medicine I, University Hospital Aachen, RWTH Aachen University, Aachen, Germany
| | | | - Lars Rydén
- Department of Medicine K2, Karolinska Institute, Stockholm, Sweden
| | | | - Linong Ji
- Peking University People’s Hospital, Beijing, China
| | - Wayne Huey-Herng Sheu
- Division of Endocrinology and Metabolism, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung City
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Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Muñoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. ENDOCRINOL DIAB NUTR 2023; 70:389-395. [PMID: 37356876 DOI: 10.1016/j.endien.2021.12.012] [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: 09/17/2021] [Accepted: 12/22/2021] [Indexed: 06/27/2023]
Abstract
AIM To evaluate the effect of faster aspart over glycaemic variability in type 1 diabetes (T1D) patients treated with sensor-augmented pump (SAP) in a real-world scenario. METHODS Observational study with SAP-treated adult T1D patients treated with faster aspart for three months. The primary endpoint was the mean amplitude of glucose excursions (MAGE). RESULTS Fifty patients were treated with faster aspart. Eleven patients (23%) withdrew during the follow-up mainly due to worsening of diabetes control (9 patients). Mean age was 41.2 yrs. (range 21-59) and T1D duration 22.4±10.0 yrs. Mean SAP treatment duration was 3.6±3.1 yrs. We detected a reduction of -7.0 (95% CI -1.1, -12.9; p=0.021) in MAGE at the end of the study. Other glycemic variability indices were also improved: standard deviation of mean interstitial glucose (-3mg/dl; 95% CI, -1, -5; p=0.01), CONGA4 (-2.2; 95% CI -0.3, -4.2; p=0.029), CONGA6 (-2.6; 95% CI -0.6, -4.6; p=0.011), GRADE (-0.5; 95% CI -0.1, -0.9; p=0.022), HBGI (-0.7; 95% CI -0.2, -1.3; p=0.013), J-index (-2.9; 95% CI -0.7, -5.0; p=0.011) and MODD (-5.7; 95% CI -1.7, -9.7; p=0.006). A slight reduction in mean glucose management indicator was also detected (-0.14%; 95% CI, -0.02, -0.27; -1.4mmol/mol; 95% CI -0.1, -3.3; p=0.03). CONCLUSIONS In SAP-treated T1D patients, faster aspart insulin was associated with reduced glycaemic variability, but also a high percentage of dropouts due to worsened glycaemic control. NCT04233203.
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Affiliation(s)
- Jesus Moreno-Fernandez
- Endocrinology and Nutrition Department, Ciudad Real General University Hospital, Ciudad Real, Spain.
| | - Jose Alberto Garcia-Seco
- Endocrinology and Nutrition Department, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - Rita Virlaboa-Cebrian
- Endocrinology and Nutrition Department, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - Angela Maria Seco
- Endocrinology and Nutrition Department, Ciudad Real General University Hospital, Ciudad Real, Spain
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Ware J, Hovorka R. Closed-loop insulin delivery: update on the state of the field and emerging technologies. Expert Rev Med Devices 2022; 19:859-875. [PMID: 36331211 PMCID: PMC9780196 DOI: 10.1080/17434440.2022.2142556] [Citation(s) in RCA: 13] [Impact Index Per Article: 4.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/01/2022] [Accepted: 10/28/2022] [Indexed: 11/06/2022]
Abstract
INTRODUCTION Over the last five years, closed-loop insulin delivery systems have transitioned from research-only to real-life use. A number of systems have been commercialized and are increasingly used in clinical practice. Given the rapidity of new developments in the field, understanding the capabilities and key similarities and differences of current systems can be challenging. This review aims to provide an update on the state of the field of closed-loop insulin delivery systems, including emerging technologies. AREAS COVERED We summarize key clinical safety and efficacy evidence of commercial and emerging insulin-only hybrid closed-loop systems for type 1 diabetes. A literature search was conducted and clinical trials using closed-loop systems during free-living conditions were identified to report on safety and efficacy data. We comment on emerging technologies and adjuncts for closed-loop systems, as well as non-technological priorities in closed-loop insulin delivery. EXPERT OPINION Commercial hybrid closed-loop insulin delivery systems are efficacious, consistently improving glycemic control when compared to standard therapy. Challenges remain in widespread adoption due to clinical inertia and the lack of resources to embrace technological developments by health care professionals.
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Affiliation(s)
- Julia Ware
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom
- Department of Pediatrics, University of Cambridge, Cambridge, United Kingdom
| | - Roman Hovorka
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, United Kingdom
- Department of Pediatrics, University of Cambridge, Cambridge, United Kingdom
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Muley A, Fernandez R, Green H, Muley P. Effect of thiamine supplementation on glycaemic outcomes in adults with type 2 diabetes: a systematic review and meta-analysis. BMJ Open 2022; 12:e059834. [PMID: 36008064 PMCID: PMC9422810 DOI: 10.1136/bmjopen-2021-059834] [Citation(s) in RCA: 7] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/21/2022] Open
Abstract
BACKGROUND Patients with type 2 diabetes mellitus (T2DM) have been shown to have thiamine deficiency. Dietary supplementation is an economic strategy to control blood glucose. Objective: To evaluate effectiveness of thiamine supplementation on glycaemic outcomes in patients with T2DM. METHODS Eligibility criteria: Studies that assessed effect of thiamine supplementation in adults with T2DM which measured glycaemic outcomes-HbA1c, fasting blood glucose (FBG) and/or postprandial blood glucose (PPG) were included. Information sources: PUBMED, Tripdatabase, the Cochrane Central Register, National Institute of Health Clinical Database and Google Scholar were searched until December 2021 for RCTs. Risk of bias: It was assessed using standardised critical appraisal instruments from the Joanna Briggs Institute for RCTs. Synthesis of results: Where possible, studies were pooled in a meta-analysis. Results were presented in a narrative format if statistical pooling was not possible. RESULTS Included studies: Six trials involving 364 participants. Synthesis of results: No significant beneficial effects were observed on glycaemic outcomes with 100-900 mg/day of thiamine or benfotiamine for up to 3 months (HbA1c: MD, -0.02%, 95% CI: -0.35 to 0.31; FBG: MD,-0.20 mmol/L; 95% CI: -0.69 to 0.29; PPG: MD, - 0.20 mmol/L, 95% CI: -2.05 to 1.65 (mean difference, MD)). There was a significant increase in high-density lipoprotein (HDL) (MD, 0.10; 95% CI: 0.10 to 0.20) at 3-month follow-up. Benfotiamine reduced triglyceride level (MD, -1.10; 95% CI: -1.90 to -0.30) in 120 mg/day dose as compared with placebo 150 mg/day, however this was not demonstrated in higher doses. DISCUSSION Limitations of evidence: Inclusion of single-centre trials published only in English, small sample sizes of included studies, lack of trials investigating outcomes for same comparisons and varying follow-up periods. Interpretation: Thiamine supplementation does not affect glycaemic outcomes, however reduces triglycerides while increasing HDL. Multicentre well-designed RCT with higher doses of thiamine and a follow-up period of 1-2 years will provide better evidence. PROSPERO REGISTRATION NUMBER CRD42020170520.
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Affiliation(s)
- Arti Muley
- Medicine, PIMSR, Parul University, Vadodara, Gujarat, India
| | - Ritin Fernandez
- Nursing, University of Wollongong Faculty of Science Medicine and Health, Wollongong, New South Wales, Australia
| | - Heidi Green
- Nursing, Centre for Research in Nursing and Health, St George Hospital, Sydney, New South Wales, Australia
| | - Prasad Muley
- Pediatrics, PIMSR, Parul University, Vadodara, Gujarat, India
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Elbalshy M, Haszard J, Smith H, Kuroko S, Galland B, Oliver N, Shah V, de Bock MI, Wheeler BJ. Effect of divergent continuous glucose monitoring technologies on glycaemic control in type 1 diabetes mellitus: A systematic review and meta-analysis of randomised controlled trials. Diabet Med 2022; 39:e14854. [PMID: 35441743 PMCID: PMC9542260 DOI: 10.1111/dme.14854] [Citation(s) in RCA: 45] [Impact Index Per Article: 15.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/26/2022] [Revised: 03/16/2022] [Accepted: 04/12/2022] [Indexed: 12/17/2022]
Abstract
AIMS We aimed to conduct a systematic review and meta-analysis of randomised controlled clinical trials (RCTs) assessing separately and together the effect of the three distinct categories of continuous glucose monitoring (CGM) systems (adjunctive, non-adjunctive and intermittently-scanned CGM [isCGM]), compared with traditional capillary glucose monitoring, on HbA1c and CGM metrics. METHODS PubMed, Web of Science, Scopus and Cochrane Central register of clinical trials were searched. Inclusion criteria were as follows: randomised controlled trials; participants with type 1 diabetes of any age and insulin regimen; investigating CGM and isCGM compared with traditional capillary glucose monitoring; and reporting glycaemic outcomes of HbA1c and/or time-in-range (TIR). Glycaemic outcomes were extracted post-intervention and expressed as mean differences and 95%CIs between treatment and comparator groups. Results were pooled using a random-effects meta-analysis. Risk of bias was assessed using the Cochrane Rob2 tool. RESULTS This systematic review was conducted between January and April 2021; it included 22 RCTs (15 adjunctive, 5 non-adjunctive, and 2 isCGM)). The overall analysis of the pooled three categories showed a statistically significant absolute improvement in HbA1c percentage points (mean difference (95% CI): -0.22% [-0.31 to -0.14], I2 = 79%) for intervention compared with comparator and was strongest for adjunctive CGM (-0.26% [-0.36, -0.16]). Overall TIR (absolute change) increased by 5.4% (3.5 to 7.2), I2 = 71% for CGM intervention compared with comparator and was strongest with non-adjunctive CGM (6.0% [2.3, 9.7]). CONCLUSIONS For individuals with T1D, use of CGM was beneficial for impacting glycaemic outcomes including HbA1c, TIR and time-below-range (TBR). Glycaemic improvement appeared greater for TIR for newer non-adjunctive CGM technology.
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Affiliation(s)
- Mona Elbalshy
- Department of Women’s and Children’s HealthDunedin School of MedicineUniversity of OtagoDunedinNew Zealand
| | - Jillian Haszard
- Division of SciencesUniversity of Otago, New ZealandDunedinNew Zealand
| | - Hazel Smith
- Department of Women’s and Children’s HealthDunedin School of MedicineUniversity of OtagoDunedinNew Zealand
| | - Sarahmarie Kuroko
- Department of Women’s and Children’s HealthDunedin School of MedicineUniversity of OtagoDunedinNew Zealand
| | - Barbara Galland
- Department of Women’s and Children’s HealthDunedin School of MedicineUniversity of OtagoDunedinNew Zealand
| | - Nick Oliver
- Department of Metabolism, Digestion and ReproductionFaculty of MedicineImperial CollegeLondonUK
| | - Viral Shah
- Barbara Davis Center for DiabetesUniversity of Colorado Anschutz Medical CampusAuroraColoradoUSA
| | | | - Benjamin J. Wheeler
- Department of Women’s and Children’s HealthDunedin School of MedicineUniversity of OtagoDunedinNew Zealand
- Paediatric EndocrinologySouthern District Health BoardDunedinNew Zealand
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Liang Y, Hou L, Wu W, Ye F, Zhang C, Luo X. History of pediatric type 1 diabetes in China. Pediatr Diabetes 2022; 23:551-555. [PMID: 34403181 DOI: 10.1111/pedi.13258] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/10/2021] [Accepted: 08/16/2021] [Indexed: 01/17/2023] Open
Abstract
The incidence of type 1 diabetes mellitus (T1DM) in children has been increasing worldwide. However, there is not much information about the situation of pediatric T1DM in China. In the past 60 years, the clinical management and research of pediatric T1DM in China have made tremendous progress. We introduced the history of pediatric diabetes in China. In addition to review the current situation of research in pediatric diabetes, we summarized the progress in the treatment and management of pediatric T1DM in China. Finally, we pointed out some shortcomings, which need to be improved in the future.
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Affiliation(s)
- Yan Liang
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Ling Hou
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Wei Wu
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Feng Ye
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Cai Zhang
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
| | - Xiaoping Luo
- Department of Pediatrics, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
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Moreno-Fernandez J, Garcia-Seco JA, Virlaboa-Cebrian R, Seco AM, Muñoz-Rodriguez JR, Gomez-Romero FJ. Faster-acting insulin aspart reduces glycaemic variability in sensor-augmented pump treated type 1 diabetes patients. ENDOCRINOL DIAB NUTR 2022. [DOI: 10.1016/j.endinu.2021.12.011] [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: 11/27/2022]
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Soni A, Wright N, Agwu JC, Timmis A, Drew J, Kershaw M, Moudiotis C, Regan F, Williams EC, Wan J, Ng SM. A practical approach to continuous glucose monitoring (rtCGM) and FreeStyle Libre systems (isCGM) in children and young people with Type 1 diabetes. Diabetes Res Clin Pract 2022; 184:109196. [PMID: 35033598 DOI: 10.1016/j.diabres.2022.109196] [Citation(s) in RCA: 6] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/12/2020] [Revised: 12/07/2021] [Accepted: 01/10/2022] [Indexed: 11/18/2022]
Abstract
Real-time continuous glucose monitoring (rtCGM) and FreeStyle Libre glucose monitoring systems (isCGM) are new evolving technologies used in the management of Type 1 diabetes. They offer potential to improve diabetes control and reduce hypoglycaemia. rtCGM can be linked to insulin pump providing hybrid closed loop therapy. Families of children and young people are keen to have the benefit from these technologies. These are relatively expensive so it is important that health care professionals, families of children and young people (CYP) with diabetes are adequately trained in the use of these devices. Health care professionals need to be able to make patient selection based on individual needs and preferences to achieve maximum benefit. Association of Children's Diabetes Clinicians (ACDC) developed a comprehensive guideline in 2017 to help identify which patients may be most likely to benefit and how these technologies may be practically implemented. Since then new technologies have been introduced and the use of GCM has expanded in routine clinical practice. This article, aims to provide a practical approach and help identify which patients may be most likely to benefit and how the technology may be implemented in order to maximise the clinical benefits.
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Affiliation(s)
- A Soni
- Sheffield Children's Hospital NHS Foundation Trust, Western Bank, Sheffield S10 2TH, United Kingdom.
| | - N Wright
- Sheffield Children's Hospital NHS Foundation Trust, Western Bank, Sheffield S10 2TH, United Kingdom
| | - J C Agwu
- Sandwell and west Birmingham Hospitals NHS Trust, United Kingdom
| | - A Timmis
- Countess of Chester Hospital NHS Foundation Trust, United Kingdom
| | - J Drew
- Nottingham University Hospitals NHS Trust, United Kingdom
| | - M Kershaw
- Birmingham Women's and Children's NHS Foundation Trust, United Kingdom
| | - C Moudiotis
- Royal Devon and Exeter NHS Foundation Trust, United Kingdom
| | - F Regan
- Frimley Health NHS Foundation Trust, United Kingdom
| | - E C Williams
- Hampshire Hospitals NHS Foundation Trust, United Kingdom
| | - Jessica Wan
- Sheffield Children's Hospital NHS Foundation Trust, Western Bank, Sheffield S10 2TH, United Kingdom
| | - S M Ng
- Southport and Ormskirk Hospital NHS Trust, United Kingdom
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Takagi S, Miura J, Shimura K, Hoshina S, Tsuchida Y, Takita M, Mochizuki S, Shen Z, Asanuma T, Takaike H, Babazono T. A sensor augmented pump may improve awareness of hypoglycemia and quality of life in Japanese patients with type 1 diabetes mellitus. Diabetol Int 2022; 13:280-287. [PMID: 35059264 PMCID: PMC8733106 DOI: 10.1007/s13340-021-00538-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: 04/30/2021] [Accepted: 08/23/2021] [Indexed: 10/20/2022]
Abstract
OBJECTIVE Sensor-augmented pump (SAP) therapy reportedly improves glycemic control and quality of life. However, there is limited information on changes in awareness of hypoglycemia and quality of life (QOL) after starting SAP therapy in Japanese patients with type 1 diabetes. The aim of this study was to evaluate glycemic control, awareness of hypoglycemia, and QOL after initiation of SAP therapy in these patients. METHODS The study included 20 patients with type 1 diabetes who started SAP therapy. HbA1c levels, values derived from continuous glucose monitoring [including percentages of time in target range (70-180 mg/dL), time below range (< 70 mg/dL), and time above range (> 180 mg/dL)], the Diabetes Treatment Satisfaction Questionnaire score, and the Clarke score were compared between baseline and after 3 and 6 months of SAP therapy. RESULTS There was a significant decrease in HbA1c at 3 and 6 months after starting on the SAP (p < 0.0001). There was also a significant decrease in time above range (> 180 mg/dL) at the two time points (p = 0.0069 and p = 0.0042, respectively). There was no significant change in time below range (< 70 mg/dL). There was a significant reduction in the Clarke score (p = 0.0347 and p = 0.0003, respectively) and a significant increase in the treatment satisfaction score (both p < 0.0001). There was no significant change in any of the three MOS 36-Item Short-Form Health Survey v2 component summary scores. CONCLUSION SAP therapy was associated with improvement of glycemic control, mainly by reducing hyperglycemia, and patients' satisfaction with treatment.
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Affiliation(s)
- Satoshi Takagi
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Junnosuke Miura
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Kanako Shimura
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Sari Hoshina
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Yukiko Tsuchida
- Department of Nursing, Tokyo Women’s Medical University Hospital, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Mikako Takita
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Shota Mochizuki
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Zhuo Shen
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Takuya Asanuma
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Hiroko Takaike
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
| | - Tetsuya Babazono
- Diabetes Center, Tokyo Women’s Medical University School of Medicine, 8-1 Kawada-cho Shinjuku, Tokyo, 162-8666 Japan
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Moreno-Fernandez J, Beato-Vibora P, Olvera P, Garcia-Seco JA, Gallego-Gamero F, Herrera MT, Muñoz-Rodriguez JR. Real-world outcomes of two different sensor-augmented insulin pumps with predictive low glucose suspend function in type 1 diabetes patients. Diabetes Res Clin Pract 2021; 181:109093. [PMID: 34653567 DOI: 10.1016/j.diabres.2021.109093] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/10/2021] [Revised: 09/27/2021] [Accepted: 09/29/2021] [Indexed: 11/15/2022]
Abstract
AIM To analyse the real-life outcomes of two sensor-augmented pumps (SAP) with predictive low glucose suspend (PLGS) function, Medtronic Minimed 640G™ with SmartGuard (MM640G) and Tandem T Slim X2™ with Basal-IQ™ (TTSX2), in Type 1 Diabetes Mellitus (T1DM) patients. METHODS Observational cross-sectional study using data obtained from computerized clinical records. All T1DM patients on TTSX2 therapy were compared (1:1) with MM640G treated patients selected through stratified sampling. Primary efficacy outcome was to describe time in rage (TIR, 70-180 mg/dL, 3.9-10 mmol/L) interstitial glucose differences according to a non-inferiority hypothesis with TTSX2 compared to MM640G. RESULTS Forty-four patients were analyzed (female 66%). Mean age was 38.9 yrs. (range 23-59 yrs.) and mean diabetes duration was 23.4 ± 9.2 yrs. Patients treated with TTSX2 showed a numerically slightly lower, but non-statistically significantly different, TIR from the MM640G pump group (64.9 ± 16.4% vs. 72.4 ± 17.0%, P = 0.108). Similarly, we did no find differences in HbA1c between T1D patients treated with TTSX2 and MM640G (6.8 ± 1.0% vs. 7.0 ± 0.9%, 51 ± 11 mmol/mol vs. 53 ± 10 mmol/mol, P = 0.312). Moreover, rest of evaluated glycemic outcomes were similar between both treatment groups. CONCLUSIONS Patients using two different SAP with PLGS automatic function showed similar glycaemic control in a real-world scenario. NCT04741685.
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Affiliation(s)
- J Moreno-Fernandez
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - P Beato-Vibora
- Endocrinology and Nutrition Service, Badajoz University Hospital, Badajoz, Spain
| | - P Olvera
- Endocrinology and Nutrition Service, Nuestra Señora de la Candelaria University Hospital, Tenerife, Spain
| | - J A Garcia-Seco
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - F Gallego-Gamero
- Endocrinology and Nutrition Service, Badajoz University Hospital, Badajoz, Spain
| | - M T Herrera
- Endocrinology and Nutrition Service, Nuestra Señora de la Candelaria University Hospital, Tenerife, Spain
| | - J R Muñoz-Rodriguez
- Translational Research Unit, Ciudad Real General University Hospital, Ciudad Real, Spain
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13
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Ray MK, McMichael A, Rivera-Santana M, Noel J, Hershey T. Technological Ecological Momentary Assessment Tools to Study Type 1 Diabetes in Youth: Viewpoint of Methodologies. JMIR Diabetes 2021; 6:e27027. [PMID: 34081017 PMCID: PMC8212634 DOI: 10.2196/27027] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/07/2021] [Revised: 03/26/2021] [Accepted: 04/03/2021] [Indexed: 11/13/2022] Open
Abstract
Type 1 diabetes (T1D) is one of the most common chronic childhood diseases, and its prevalence is rapidly increasing. The management of glucose in T1D is challenging, as youth must consider a myriad of factors when making diabetes care decisions. This task often leads to significant hyperglycemia, hypoglycemia, and glucose variability throughout the day, which have been associated with short- and long-term medical complications. At present, most of what is known about each of these complications and the health behaviors that may lead to them have been uncovered in the clinical setting or in laboratory-based research. However, the tools often used in these settings are limited in their ability to capture the dynamic behaviors, feelings, and physiological changes associated with T1D that fluctuate from moment to moment throughout the day. A better understanding of T1D in daily life could potentially aid in the development of interventions to improve diabetes care and mitigate the negative medical consequences associated with it. Therefore, there is a need to measure repeated, real-time, and real-world features of this disease in youth. This approach is known as ecological momentary assessment (EMA), and it has considerable advantages to in-lab research. Thus, this viewpoint aims to describe EMA tools that have been used to collect data in the daily lives of youth with T1D and discuss studies that explored the nuances of T1D in daily life using these methods. This viewpoint focuses on the following EMA methods: continuous glucose monitoring, actigraphy, ambulatory blood pressure monitoring, personal digital assistants, smartphones, and phone-based systems. The viewpoint also discusses the benefits of using EMA methods to collect important data that might not otherwise be collected in the laboratory and the limitations of each tool, future directions of the field, and possible clinical implications for their use.
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Affiliation(s)
- Mary Katherine Ray
- Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, United States
| | - Alana McMichael
- Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, United States
| | - Maria Rivera-Santana
- Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, United States
| | - Jacob Noel
- Department of Psychiatry, Washington University in St. Louis, St. Louis, MO, United States
| | - Tamara Hershey
- Department of Psychiatry, Mallinckrodt Institute of Radiology, Washington University in St. Louis, St. Louis, MO, United States
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Ulrich H, Bowen M. The clinical utility of professional continuous glucose monitoring by pharmacists for patients with type 2 diabetes. J Am Pharm Assoc (2003) 2021; 61:e76-e82. [PMID: 34154906 DOI: 10.1016/j.japh.2021.05.013] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/09/2021] [Revised: 05/25/2021] [Accepted: 05/25/2021] [Indexed: 10/21/2022]
Abstract
BACKGROUND There are limited data regarding the use of diabetes technologies, such as professional continuous glucose monitoring (CGM), as part of a pharmacist-managed diabetes service. OBJECTIVE To assess how professional CGM affected treatment decisions and glucose control as part of a pharmacist-managed service for patients with type 2 diabetes. PRACTICE DESCRIPTION Clinical Pharmacy Specialists (CPS's) within an outpatient diabetes management service provide comprehensive diabetes care under a scope of practice that includes prescriptive privileges. PRACTICE INNOVATION Insight into glucose patterns is paramount for pharmacists to use their medication expertise to its fullest capacity. CGM technology can provide detailed data on glucose trends, including percentage of time spent in a target range. Pharmacists involved in the provision of diabetes care have the opportunity to integrate professional CGM into their practice to acquire data for targeted therapeutic adjustments. EVALUATION METHODS A retrospective analysis was conducted of patients with type 2 diabetes who had professional CGM used as part of their routine diabetes care with the CPS from 2017-2019. The primary outcome was the percentage of patients meeting their individualized A1c goal at baseline versus 6 months post placement of the professional CGM. A McNemar's test was used to compare the percentage of patients achieving A1c goal pre and postintervention. A P value of <0.05 denoted the presence of a statistically significant difference. RESULTS Patients who implemented professional CGM had an average duration of diabetes of 15.6 years and an average A1c of 9.1%. The majority (76.7%) were not meeting their individualized A1c goal. Hypoglycemia was identified in 57% of the patients; almost half of patients evaluated had periods of nocturnal hypoglycemia. Hyperglycemia was present on the vast majority of reports (83%) with postprandial elevations being the most common trend identified overall. Mean A1c decreased from 9.11% ± 1.4 at baseline to 8.64% ± 1.3 at 3 months and 8.19% ± 0.8 at 6 months. Compared with baseline, more than 2 times the number of patients were within their A1c goal range at 3 and 6 months (23.3%, 53.6% and 69.6% respectively.) This represented a statistically significant difference at both time points (P = 0.008 at 3 months and P = 0.006 at 6 months.) CONCLUSION: The use of CGM technology may overcome treatment barriers, such as insufficient self-monitoring of blood glucose and lack of discernment of glucose trends with traditional A1c testing. Pharmacists employing professional CGM as part of a diabetes management service were able to achieve targets for significantly more patients with type 2 diabetes on a wide range of treatment regimens at 6 months compared with baseline. Widespread use of professional CGM in pharmacist-managed diabetes services may provide valuable care and improve outcomes more broadly. Larger randomized trials are warranted to examine ideal patient selection and optimal frequency of use.
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15
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Muley A, Fernandez R, Ellwood L, Muley P, Shah M. Effect of tree nuts on glycemic outcomes in adults with type 2 diabetes mellitus: a systematic review. JBI Evid Synth 2021; 19:966-1002. [PMID: 33141798 DOI: 10.11124/jbisrir-d-19-00397] [Citation(s) in RCA: 10] [Impact Index Per Article: 2.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
Abstract
OBJECTIVE The objective of this review was to synthesize the best available research evidence regarding the effectiveness of tree nuts on glycemic outcomes in adults with type 2 diabetes mellitus. INTRODUCTION There has been an increase in the use of complementary therapy, particularly botanical products, for management of type 2 diabetes mellitus. It has been reported that increasing mono- and polyunsaturated fatty acids in diet effectively lowers the risk of development of type 2 diabetes mellitus. Hence, it was hypothesized that consumption of nuts, which are high in polyunsaturated fatty acids and mono-unsaturated fatty acids, may aid in preventing diabetes and reducing levels of blood glucose by reducing glycemic load by displacing dietary carbohydrates present in diet. INCLUSION CRITERIA This systematic review included randomized controlled trials that compared the consumption of any type and form of tree nut with a placebo or any other intervention in adults with type 2 diabetes mellitus. Trials were included if they measured fasting blood glucose, postprandial blood glucose, and/or glycated hemoglobin. Trials that assessed triglyceride levels and weight postintervention were also considered for inclusion. Trials were restricted to the English language. METHODS A three step search of PubMed, CINAHL, Embase, Trip database, and Cochrane Central Register of Controlled Trials (CENTRAL) was done in July 2019. To find unpublished studies, ClinicalTrials.gov and Google Scholar were searched. Studies from the search were reviewed against the inclusion criteria by two reviewers. The JBI critical appraisal checklist for randomized controlled trials was used to assess the potential studies for methodological quality. A meta-analysis and subgroup analysis was conducted among trials with the same type of intervention and outcome measures. Results are presented in a narrative format where statistical pooling was not possible. RESULTS Fifteen trials were included with a total sample size of 667. Consumption of pistachios demonstrated a significant reduction in triglyceride levels (mmol/L) at three month or earlier follow-up (mean difference [MD] -0.28; confidence interval -0.33, -0.23; P <0.00001). The meta-analysis including all tree nuts combined showed reduction in both fasting blood glucose and glycated hemoglobin (MD -0.26 mmol/L and -0.11% respectively) at three month or earlier follow-up. The subgroup analysis demonstrated MD of -0.45, -0.16, and -0.90 mmol/L in fasting blood glucose following ingestion of walnuts, almonds, and hazelnuts, respectively, and -0.17% in glycated hemoglobin following ingestion of walnuts at three month or earlier follow-up. Although not clinically significant, these figures give an indication that further research with larger sample sizes and longer follow-up may show encouraging results. CONCLUSIONS The authors found that pistachio consumption for three months or less significantly reduced triglyceride levels. Other tree nuts (walnuts, almonds, and hazelnuts) reduced fasting blood glucose and glycated hemoglobin levels by varying degrees. Further robust randomized controlled trials with power calculation-based sample size, comparing same type, dose, and method of nut intervention, will provide more evidence. For now, clinical decisions should be based on standard practice local guidelines. SYSTEMATIC REVIEW REGISTRATION NUMBER PROSPERO CRD42019133558.
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Affiliation(s)
- Arti Muley
- Sumandeep Vidyapeeth Centre for Evidence Based Health Care: A JBI Affiliated Group, Vadodara, India
| | - Ritin Fernandez
- Centre for Evidence Based Initiatives in Health Care: A JBI Centre of Excellence, Wollongong, NSW, Australia.,Centre for Research in Nursing and Health, St George Hospital, Sydney, NSW, Australia.,School of Nursing, University of Wollongong, Sydney, NSW, Australia
| | - Laura Ellwood
- Centre for Evidence Based Initiatives in Health Care: A JBI Centre of Excellence, Wollongong, NSW, Australia.,Centre for Research in Nursing and Health, St George Hospital, Sydney, NSW, Australia
| | - Prasad Muley
- Sumandeep Vidyapeeth Centre for Evidence Based Health Care: A JBI Affiliated Group, Vadodara, India
| | - Monali Shah
- Sumandeep Vidyapeeth Centre for Evidence Based Health Care: A JBI Affiliated Group, Vadodara, India
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16
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Dicembrini I, Cosentino C, Monami M, Mannucci E, Pala L. Effects of real-time continuous glucose monitoring in type 1 diabetes: a meta-analysis of randomized controlled trials. Acta Diabetol 2021; 58:401-410. [PMID: 32789691 DOI: 10.1007/s00592-020-01589-3] [Citation(s) in RCA: 64] [Impact Index Per Article: 16.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/05/2020] [Accepted: 07/30/2020] [Indexed: 02/07/2023]
Abstract
AIMS Self-monitoring of blood glucose (SMBG) represented a major breakthrough in the treatment of type 1 diabetes. The aim of the present meta-analysis is to assess the effect of continues glucose monitoring (CGM) and flash glucose monitoring (FGM), on glycemic control in type 1 diabetes. MATERIALS AND METHODS The present analysis includes randomized clinical trials comparing CGM or FGM with SMBG, with a duration of at least 12 weeks, identified in Medline or clinicaltrials.gov. The principal endpoint was HbA1c at the end of the trial. A secondary endpoint was severe hypoglycemia. Mean and 95% confidence intervals for HbA1c and Mantel-Haenzel odds ratio [MH-OR] for severe hypoglycemia were calculated, using random effect models. A sensitivity analysis was performed using fixed effect models. In addition, the following secondary endpoints were explored, using the same methods: time in range, health-related quality of life, and treatment satisfaction. Separate analyses were performed for trials comparing CGM with SMBG, and those comparing CGM + CSII and SMBG + MDI and CGM-regulated insulin infusion system (CRIS) and CSII + SMBG. RESULTS CGM was associated with a significantly lower HbA1c at endpoint in comparison with SMBG (- 0.24 [- 0.34, - 0.13]%); CGM was associated with a significantly lower risk of severe hypoglycemia than SMBG. Treatment satisfaction and quality of life were not measured, or not reported, in the majority of studies. FGM showed a significant reduction in the incidence of mild hypoglycemia and an increased treatment satisfaction, but no significant results are shown in HbA1c. CGM + CSII in comparison with SMBG + MDI was associated with a significant reduction in HbA1c. Only two trials with a duration of at least 12 weeks compared a CRIS with SMBG + CSII; HbA1c between the two treatment arms was not statistically significant (difference in means: - 0.23 [- 0.91; 0.46]%; p = 0.52). CONCLUSION GCM compared to SMBG has showed a reduction in HbA1c and severe hypoglycemia in patient with type 1 diabetes. The comparison between CGM + CSII and SMBG + MDI showed a large reduction in HbA1c; it is conceivable that the effects of CSII + CGM on glycemic control additives. The only comparison available between FGM and SMBG was conducted in patients in good control.
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Affiliation(s)
- I Dicembrini
- Diabetology, Careggi Hospital, Florence, Italy
- University of Florence, Florence, Italy
| | - C Cosentino
- Diabetology, Careggi Hospital, Florence, Italy
| | - M Monami
- Diabetology, Careggi Hospital, Florence, Italy
| | - E Mannucci
- Diabetology, Careggi Hospital, Florence, Italy
- University of Florence, Florence, Italy
| | - L Pala
- Diabetology, Careggi Hospital, Florence, Italy.
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17
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Lawson ML, Verbeeten KC, Courtney JM, Bradley BJ, McAssey K, Clarson C, Kirsch S, Curtis JR, Mahmud FH, Richardson C, Cooper T, Chan J, Tang K. Timing of CGM initiation in pediatric diabetes: The CGM TIME Trial. Pediatr Diabetes 2021; 22:279-287. [PMID: 33098212 PMCID: PMC7984035 DOI: 10.1111/pedi.13144] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/07/2020] [Accepted: 10/18/2020] [Indexed: 01/07/2023] Open
Abstract
OBJECTIVE To determine whether timing of CGM initiation offering low glucose suspend (LGS) affects CGM adherence in children and youth starting insulin pump therapy. METHODS A 5-site RCT of pump-naïve subjects (aged 5-18 years) with type 1 diabetes (T1D) for at least 1 year compared simultaneous pump and CGM initiation offering LGS vs standard pump therapy with CGM initiation delayed for 6 months. Primary outcome was CGM adherence (hours per 28 days) (MiniMed™ Paradigm™ Veo™ system; CareLink Pro™ software) over 6 months after CGM initiation. Secondary outcome HbA1c was measured centrally. Linear mixed-models and ordinary least squares models were fitted to estimate effect of intervention, and covariates baseline age, T1D duration, HbA1c, gender, ethnicity, hypoglycemia history, clinical site, and association between CGM adherence and HbA1c. RESULTS The trial randomized 144/152 (95%) eligible subjects. Baseline mean age was 11.5 ± 3.3(SD) years, T1D duration 3.4 ± 3.1 years, and HbA1c 7.9 ± 0.9%. Six months after CGM initiation, adjusted mean difference in CGM adherence was 62.4 hours per 28 days greater in the Simultaneous Group compared to Delayed Group (P = .007). There was no difference in mean HbA1c at 6 months. However, for each 100 hours of CGM use per 28-day period, HbA1c was 0.39% (95% CI 0.10%-0.69%) lower. Higher CGM adherence was associated with reduced time with glucose >10 mmol/L (P < .001). CONCLUSION CGM adherence was higher after 6 months when initiated at same time as pump therapy compared to starting CGM 6 months after pump therapy. Greater CGM adherence was associated with improved HbA1c.
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Affiliation(s)
- Margaret L. Lawson
- Division of Endocrinology and Metabolism, Department of PediatricsChildren's Hospital of Eastern OntarioOttawaOntarioCanada,Clinical Research UnitCHEO Research InstituteOttawaOntarioCanada
| | - Kate C. Verbeeten
- Division of Endocrinology and Metabolism, Department of PediatricsChildren's Hospital of Eastern OntarioOttawaOntarioCanada,Clinical Research UnitCHEO Research InstituteOttawaOntarioCanada
| | | | | | - Karen McAssey
- Department of PediatricsMcMaster Children's HospitalHamiltonOntarioCanada
| | - Cheril Clarson
- Department of Pediatrics, Children's Hospital, London Health Sciences CentreLawson Health Research InstituteLondonOntarioCanada
| | - Susan Kirsch
- Department of PediatricsMarkham‐Stouffville HospitalMarkhamOntarioCanada
| | - Jacqueline R Curtis
- Division of Endocrinology, Department of PediatricsHospital for Sick ChildrenTorontoOntarioCanada
| | - Farid H Mahmud
- Division of Endocrinology, Department of PediatricsHospital for Sick ChildrenTorontoOntarioCanada
| | - Christine Richardson
- Division of Endocrinology and Metabolism, Department of PediatricsChildren's Hospital of Eastern OntarioOttawaOntarioCanada
| | - Tammy Cooper
- Division of Endocrinology and Metabolism, Department of PediatricsChildren's Hospital of Eastern OntarioOttawaOntarioCanada
| | - Jason Chan
- Clinical Research UnitCHEO Research InstituteOttawaOntarioCanada
| | - Ken Tang
- Clinical Research UnitCHEO Research InstituteOttawaOntarioCanada
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18
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Methoden der Stoffwechselkontrolle – HbA1c versus „time in range“. DIABETOLOGE 2021. [DOI: 10.1007/s11428-021-00730-2] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 10/22/2022]
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19
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Schlüter S, Freckmann G, Heinemann L, Wintergerst P, Lange K. Evaluation of the SPECTRUM training programme for real-time continuous glucose monitoring: A real-world multicentre prospective study in 120 adults with type 1 diabetes. Diabet Med 2021; 38:e14467. [PMID: 33230860 DOI: 10.1111/dme.14467] [Citation(s) in RCA: 22] [Impact Index Per Article: 5.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/08/2020] [Revised: 11/12/2020] [Accepted: 11/14/2020] [Indexed: 12/14/2022]
Abstract
AIMS Comprehensive knowledge, specific skills and data-analysis competences are prerequisites for the successful use of continuous glucose monitoring (CGM) systems. SPECTRUM is a structured training programme for real-time CGM (rtCGM) consisting of a web-based introduction and six group sessions of 90 min each. The 'CGM-TRAIN study' evaluated the efficacy and acceptance of SPECTRUM and rtCGM systems among adults with insulin therapy. METHODS Participants (n = 120) were recruited from 10 German diabetes centres in which they were treated under usual care conditions. Outcome measures were rtCGM knowledge, practical skills, satisfaction with the training programme, satisfaction and acceptance of rtCGM system and glycaemic control. Data were collected at study entry, after training completion and at 6-month follow-up. RESULTS All participants were diagnosed with type 1 diabetes (56% women, mean age 42.4 ± 13.4 years, diabetes duration 21.6 ± 11.6 years), 110 participants completed the course. After training completion, rtCGM-specific knowledge had improved by 43% (scale: 0-40 points) from 21.2 ± 7.6 to 30.4 ± 4.5 points; p < 0.001. The knowledge-level persisted until follow-up (29.4 ± 4.5). Participants were able to master nearly all the practical requirements of the technology. In addition, rtCGM was highly accepted, and participants were motivated to use their systems continuously. HbA1c improved slightly from 61 ± 14 mmol/mol (7.7 ± 1.3%) before training to 60 ± 14 mmol/mol (7.6 ± 1.3%) at follow-up (p = 0.04). The training programme itself was favourably rated by participants. CONCLUSIONS Under usual out-patient daily care conditions, the training programme SPECTRUM improved knowledge and skills about rtCGM in adults with type 1 diabetes. This was associated with a reduced HbA1c , high satisfaction and acceptance of rtCGM (Clinical Trials Registry no.: DRKS00014380).
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Affiliation(s)
- Sandra Schlüter
- Diabetesschwerpunktpraxis Northeim, Northeim, Germany
- Hannover Medical School - Medical Psychology, Hannover, Germany
| | - Guido Freckmann
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | | | - Peter Wintergerst
- Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany
| | - Karin Lange
- Hannover Medical School - Medical Psychology, Hannover, Germany
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20
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Moorman JM. Part I: Continuous glucose monitoring systems. JOURNAL OF THE AMERICAN COLLEGE OF CLINICAL PHARMACY 2020. [DOI: 10.1002/jac5.1260] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
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21
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Grando MA, Bayuk M, Karway G, Corrette K, Groat D, Cook CB, Thompson B. Patient Perception and Satisfaction With Insulin Pump System: Pilot User Experience Survey. J Diabetes Sci Technol 2019; 13:1142-1148. [PMID: 31055947 PMCID: PMC6835185 DOI: 10.1177/1932296819843146] [Citation(s) in RCA: 13] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
BACKGROUND The goal of this study was to assess patient perspectives and satisfaction with the MiniMed 670G insulin pump. Those participants who used the pump as part of a hybrid closed loop were also asked to provide their views on the automatic feature (auto mode). METHODS Adults with type 1 diabetes mellitus using the Medtronic™ 670G pump were asked about their experience with the device using a semi-structured survey developed by the research team. Responses were quantified to identify emergent themes. RESULTS Seventeen participants used the pump as part of a hybrid closed loop system, while four participants used the pump in combination with a nonintegrated continuous glucose monitoring system. Overall, participants indicated a high level of satisfaction with the pump (14/21) mostly because of improvements in blood glucose (BG) control (15/21). Least liked features were physical design and structure (6/21), frequency of user input (5/21), alert frequency (4/21), and difficulty of use (3/21). Those using the hybrid closed loop were satisfied with the auto mode feature (11/17), mostly because of improvements in BG control (9/17). The least liked features of the auto mode technology were that blood glucose levels remained elevated (5/17) and the frequency of alerts (4/17). CONCLUSION Participants indicated a high level of satisfaction with the pump and its auto mode featured mostly because of improvements in BG control. They also pointed out some key aspects of the device that are of potential clinical or commercial relevance. Additional research is needed to further evaluate users' perspectives on this new device.
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Affiliation(s)
- Maria Adela Grando
- Biomedical Informatics, College of Health Solutions, Arizona State University, Scottsdale, AZ, USA
- Maria Adela Grando, PhD, Biomedical Informatics, College of Health Solutions, Arizona State University, 13212 E Shea Blvd, Scottsdale, AZ 85259, USA.
| | - Mike Bayuk
- Biomedical Informatics, College of Health Solutions, Arizona State University, Scottsdale, AZ, USA
| | - George Karway
- Biomedical Informatics, College of Health Solutions, Arizona State University, Scottsdale, AZ, USA
| | - Krystal Corrette
- Biomedical Informatics, College of Health Solutions, Arizona State University, Scottsdale, AZ, USA
| | - Danielle Groat
- Biomedical Informatics, College of Health Solutions, Arizona State University, Scottsdale, AZ, USA
- Department of Biomedical Informatics, University of Utah, Salt Lake City, UT, USA
| | - Curtiss B. Cook
- Department of Endocrinology, Arizona Mayo Clinic, Scottsdale, AZ, USA
| | - Bithika Thompson
- Department of Endocrinology, Arizona Mayo Clinic, Scottsdale, AZ, USA
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22
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Zhang ZY, Miao LF, Qian LL, Wang N, Qi MM, Zhang YM, Dang SP, Wu Y, Wang RX. Molecular Mechanisms of Glucose Fluctuations on Diabetic Complications. Front Endocrinol (Lausanne) 2019; 10:640. [PMID: 31620092 PMCID: PMC6759481 DOI: 10.3389/fendo.2019.00640] [Citation(s) in RCA: 62] [Impact Index Per Article: 10.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/06/2018] [Accepted: 09/03/2019] [Indexed: 12/11/2022] Open
Abstract
Accumulating evidence indicates the occurrence and development of diabetic complications relates to not only constant high plasma glucose, but also glucose fluctuations which affect various kinds of molecular mechanisms in various target cells and tissues. In this review, we detail reactive oxygen species and their potentially damaging effects upon glucose fluctuations and resultant downstream regulation of protein signaling pathways, including protein kinase C, protein kinase B, nuclear factor-κB, and the mitogen-activated protein kinase signaling pathway. A deeper understanding of glucose-fluctuation-related molecular mechanisms in the development of diabetic complications may enable more potential target therapies in future.
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Affiliation(s)
| | | | | | | | | | | | | | | | - Ru-Xing Wang
- Department of Cardiology, Wuxi People's Hospital Affiliated to Nanjing Medical University, Wuxi, China
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23
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Sandy JL, Nyunt O, Woodhead HJ, Youde LS, Ramjan KA, Jack MM, Lim L, Shepherd M, Marshall A, Townsend N, Wilson S, Duke SA, Slavich E, Hameed S. Sydney Diabetes centre's experience of the Australian Government's roll out of subsidised continuous glucose monitoring for children with type 1 diabetes mellitus. J Paediatr Child Health 2019; 55:1056-1062. [PMID: 30565355 DOI: 10.1111/jpc.14340] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/02/2018] [Revised: 11/17/2018] [Accepted: 11/26/2018] [Indexed: 11/28/2022]
Abstract
AIM To determine patient/carer expectations of continuous glucose monitoring (CGM) and short-term satisfaction, to assess the efficacy of CGM in improving: fear of hypoglycaemia and glycaemic control (HbA1c , ketosis, hypoglycaemia) and to determine time requirements of diabetes clinic staff in commencing and administering CGM. METHODS We assessed CGM-naïve patients starting on CGM at a Sydney Diabetes Centre following the introduction of a nationwide government subsidy for CGM. A standardised questionnaire was administered collecting demographic and glycaemic information in addition to Likert scale assessment of expectations and satisfaction. Clinic staff reported time dedicated to CGM education, commencement and follow-up. RESULTS A total of 55 patients or parents/carers completed baseline questionnaires, with 37 completing a 3-month follow-up questionnaire. There were high expectations of CGM prior to commencement and high satisfaction ratings on follow-up. CGM improved fear of hypoglycaemia, and total daily insulin dose increased after commencement of CGM. There was a trend towards lower HbA1c that was not statistically significant and no statistically significant reduction in ketosis or hypoglycaemia. Comments were mostly positive, with some concern raised regarding technical issues and a lack of subsidy after 21 years of age. Staff time requirements were substantial, with an estimated average of 7.7 h per patient per year. CONCLUSIONS Patients and families have high expectations of CGM, and satisfaction levels are high in the short term. Total insulin delivery increased after CGM commencement. Time requirements by staff are substantial but are worthwhile if families' overall satisfaction levels are high.
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Affiliation(s)
- Jessica L Sandy
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Faculty of Medicine, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia
| | - Ohn Nyunt
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Faculty of Medicine, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.,Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia
| | - Helen J Woodhead
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Faculty of Medicine, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia
| | - Lesley S Youde
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Kim A Ramjan
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Discipline of Child and Adolescent Health, Faculty of Medicine and Health, University of Sydney, Sydney, New South Wales, Australia.,School of Medicine, Western Sydney University, Sydney, New South Wales, Australia
| | - Michelle M Jack
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia
| | - Lena Lim
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Margaret Shepherd
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Ailsa Marshall
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Nicky Townsend
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Suzi Wilson
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Sally-Anne Duke
- Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia.,Department of Diabetes and Endocrinology, Royal North Shore Hospital, Sydney, New South Wales, Australia
| | - Eve Slavich
- Stats Central, Mark Wainwright Analytical Centre, University of New South Wales, Sydney, New South Wales, Australia
| | - Shihab Hameed
- Department of Paediatric Diabetes and Endocrinology, Clinical Services Building, Royal North Shore Hospital, Sydney, New South Wales, Australia.,Faculty of Medicine, School of Women's and Children's Health, University of New South Wales, Sydney, New South Wales, Australia.,Northern Clinical School, University of Sydney, Sydney, New South Wales, Australia
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24
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Guilmin-Crépon S, Carel JC, Schroedt J, Sulmont V, Salmon AS, Le Tallec C, Coutant R, Dalla-Vale F, Stuckens C, Bony-Trifunovic H, Crosnier H, Kurtz F, Kaguelidou F, Le Jeannic A, Durand-Zaleski I, Couque N, Alberti C, Tubiana-Rufi N. Is there an optimal strategy for real-time continuous glucose monitoring in pediatrics? A 12-month French multi-center, prospective, controlled randomized trial (Start-In!). Pediatr Diabetes 2019; 20:304-313. [PMID: 30663187 DOI: 10.1111/pedi.12820] [Citation(s) in RCA: 10] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/09/2018] [Revised: 11/14/2018] [Accepted: 01/02/2019] [Indexed: 02/06/2023] Open
Abstract
AIM To compare the efficacy of three strategies for real-time continuous glucose monitoring (RT-CGM) over 12 months in children and adolescents with type 1 diabetes. METHODS A French multicenter trial (NCT00949221) with a randomized, controlled, prospective, open, and parallel-group design was conducted. After 3 months of RT-CGM, patients were allocated to one of three groups: return to self-monitoring of blood glucose, continuous CGM (80% of the time), or discontinuous CGM (40% of the time). The primary outcome was hemoglobin A1c (HbA1c) levels from 3 to 12 months. The secondary outcomes were acute metabolic events, hypoglycemia, satisfaction with CGM and cost. RESULTS We included 151 subjects, aged 2 to 17 years, with a mean HbA1c level of 8.5% (SD0.7; 69 mmol/mol). The longitudinal change in HbA1c levels was similar in all three groups, at 3, 6, 9 and 12 months. The medical secondary endpoints did not differ between groups. The rate of severe hypoglycemia was significantly lower than that for the pretreatment year for the entire study population. Subjects reported consistent use and good tolerance of the device, regardless of age or insulin treatment. The use of full-time RT-CGM for 3 months costs the national medical insurance system €2629 per patient. CONCLUSION None of the three long-term RT-CGM strategies evaluated in pediatric type 1 diabetes was superior to the others in terms of HbA1c levels. CGM-use for 3 months decreased rates of severe hypoglycemia. Our results confirm the feasibility of long-term RT-CGM-use and the need to improve educational support for patients and caregivers.
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Affiliation(s)
- Sophie Guilmin-Crépon
- Pediatric Endocrinology and Diabetology Department and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, CHU Robert Debré, AP-HP, Paris, France.,Unit of Clinical Epidemiology, CHU Robert Debré, APHP, Paris, France.,Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France.,University Paris Diderot, Sorbonne Paris Cité, Paris, France
| | - Jean-Claude Carel
- Pediatric Endocrinology and Diabetology Department and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, CHU Robert Debré, AP-HP, Paris, France.,Inserm, PROTECT, Université Paris Diderot, Paris, France.,University Paris Diderot, Sorbonne Paris Cité, Paris, France
| | - Julien Schroedt
- Unit of Clinical Epidemiology, CHU Robert Debré, APHP, Paris, France.,Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France
| | | | | | - Claire Le Tallec
- Pediatric Diabetology Unit, Children's Hospital, CHU Toulouse, Toulouse, France
| | - Régis Coutant
- Pediatric Endocrinology and Diabetology Department, CHU Angers, Angers, France
| | - Fabienne Dalla-Vale
- Pediatric Unit, Arnaud de Villeneuve Children's Hospital, CHU Montpellier, Montpellier, France
| | - Chantal Stuckens
- Pediatric Unit, Jeanne de Flandre Hospital, CHU Lille, Lille, France
| | | | - Hélène Crosnier
- Pediatric Unit, Poissy Saint-Germain-en-Laye Hospital, Poissy, France
| | - François Kurtz
- Pediatric Unit, Saint Avold Hospital, Saint-Avold, France
| | | | - Anaïs Le Jeannic
- Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France.,Health Economics Clinical Research Platform (URCEco), APHP, Paris, France
| | - Isabelle Durand-Zaleski
- Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France.,Health Economics Clinical Research Platform (URCEco), APHP, Paris, France
| | - Nathalie Couque
- Department of Molecular Biochemistry, CHU Robert Debré, APHP, Paris, France
| | - Corinne Alberti
- Unit of Clinical Epidemiology, CHU Robert Debré, APHP, Paris, France.,Inserm, UMR-S 1123 ECEVE and CIC-EC 1426, Paris, France.,University Paris Diderot, Sorbonne Paris Cité, Paris, France
| | - Nadia Tubiana-Rufi
- Pediatric Endocrinology and Diabetology Department and Centre de Référence des Maladies Endocriniennes Rares de la Croissance, CHU Robert Debré, AP-HP, Paris, France.,University Paris Diderot, Sorbonne Paris Cité, Paris, France
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25
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Picard S, Bonnemaison-Gilbert E, Leutenegger E, Barat P. Optimization of insulin regimen and glucose outcomes with short-term real-time continuous glucose monitoring (RT-CGM) in type 1 diabetic children with sub-optimal glucose control on multiple daily injections: The pediatric DIACCOR study. Arch Pediatr 2019; 26:95-101. [PMID: 30642746 DOI: 10.1016/j.arcped.2018.11.010] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/04/2018] [Revised: 10/27/2018] [Accepted: 11/17/2018] [Indexed: 02/07/2023]
Abstract
BACKGROUND The impact of 7-day real-time continuous glucose monitoring (RT-CGM) on type 1 diabetes (T1D) management remains unknown in youths with suboptimal control by multiple daily injections (MDI). The DIACCOR Study aimed to describe treatment decisions and glucose outcomes after a short-term RT-CGM sequence in real-life conditions. METHODS This French multicenter longitudinal observational study included T1D youths with HbA1c>7.5% or a history of severe hypoglycemia (SH) or recurrent documented hypoglycemia. A sensor was inserted at the study-inclusion visit, and one of three predefined treatment changes was proposed by the investigator within 7-15 days: INT=MDI intensification, CSII=switch to continuous insulin infusion, or ER=educational reinforcement with no change in insulin regimen and a 4-month follow-up visit (M4) was scheduled. RESULTS A total of 229 children (12.2±3.5 years old) were recruited by 74 pediatricians; 12.8% had a history of SH, 22.2% had recurrent hypoglycemia. Baseline HbA1c was 8.7±1.5% (>7.5% in 82.8%). Overall, 139 (79.4%), 19 (10.9%), and 17 patients (9.7%) were, respectively, included in the INT, CSII, and ER subgroups. At M4, the global incidence of SH and recurrent hypoglycemia dropped (3.4% vs. 12.8% and 6.0% vs. 22.2%, respectively) as well as the incidence of ketoacidosis (2.1% vs. 8.1%) or ketosis (6.9% vs. 11.4%). The HbA1c decrease was significant overall and in the INT subgroup (adjusted difference -0.29%, P=0.009). The satisfaction rate was≥93.0% among children. CONCLUSION In a real-life setting, a 1-week RT-CGM can promote treatment optimization in youths with uncontrolled T1D resulting mostly in less acute events. CGM acceptance may improve with new-generation sensors.
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Affiliation(s)
- S Picard
- Point Médical, Rond-Point de la Nation, 21000 Dijon, France
| | - E Bonnemaison-Gilbert
- Tours University Hospital, Clocheville Hospital (USP), 49, boulevard Béranger, 37000 Tours, France
| | | | - P Barat
- Unité endocrinologie et diabétologie pédiatrique, université Bordeaux, CHU Bordeaux, 33000 Bordeaux, France.
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26
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Piona C, Dovc K, Mutlu GY, Grad K, Gregorc P, Battelino T, Bratina N. Non-adjunctive flash glucose monitoring system use during summer-camp in children with type 1 diabetes: The free-summer study. Pediatr Diabetes 2018; 19:1285-1293. [PMID: 30022571 DOI: 10.1111/pedi.12729] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/07/2018] [Revised: 06/08/2018] [Accepted: 07/02/2018] [Indexed: 02/06/2023] Open
Abstract
BACKGROUND A factory-calibrated sensor for intermittently scanned continuous glucose monitoring (isCGM) is accurate and safe in children with type 1 diabetes (T1D). Data on isCGM effectiveness as a replacement for self-monitoring of blood glucose (SMBG) in this population is scarce. OBJECTIVE The aim of this study was to evaluate the non-adjunctive use of isCGM in children with T1D during 2 weeks in a challenging summer-camp setting. METHODS In this two-arm, parallel, randomized, outpatient clinical trial we enrolled 46 children (25 females, mean ± SD: age 11.1 ± 2.6 years, glycated hemoglobin (HbA1c) 7.4% ± 0.7%): 26 in the isCGM group were blinded for the SMBG and insulin dosing was isCGM-based, whereas 20 in the control group were blinded for isCGM and performed SMBG-based insulin dosing. The primary outcome of intention-to-treat analysis was between-group difference in the proportion of time within range 3.9 to 10 mmol/L (TIR). RESULTS There was no significant difference in TIR (3.9-10 mmol/L) between the two groups. In participants with suboptimal metabolic control (HbA1c > 7%) we observed a significant reduction in time spent above 10 mmol/L (P < 0.05) and an improvement in TIR (P = 0.05) in the isCGM group. No severe hypoglycemic events or serious adverse events occurred. Overall mean absolute relative difference (MARD) between isCGM and SMBG was 18.3%, with median absolute relative difference (ARD) of 8%. Consensus error grid analysis demonstrated 82.2% and 95.2% of results in zone A, and zone A + B, respectively. CONCLUSION The non-adjunctive use of isCGM was as safe and effective as SMBG, and reduced time spent in hyperglycemia in a sub-population of children with T1D with suboptimal glycemic control. TRIAL REGISTRATION NCT03182842.
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Affiliation(s)
- Claudia Piona
- Pediatric Diabetes and Metabolic Disorders Unit, Regional Center for Pediatric Diabetes, University City Hospital, Verona, Italy
| | - Klemen Dovc
- Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre, Ljubljana, Slovenia
| | - Gül Y Mutlu
- Department of Pediatrics, Koç University Hospital, İstanbul, Turkey
| | - Klara Grad
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Petra Gregorc
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Tadej Battelino
- Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre, Ljubljana, Slovenia.,Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Nataša Bratina
- Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, University Medical Centre, Ljubljana, Slovenia
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27
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Sherr JL, Tauschmann M, Battelino T, de Bock M, Forlenza G, Roman R, Hood KK, Maahs DM. ISPAD Clinical Practice Consensus Guidelines 2018: Diabetes technologies. Pediatr Diabetes 2018; 19 Suppl 27:302-325. [PMID: 30039513 DOI: 10.1111/pedi.12731] [Citation(s) in RCA: 133] [Impact Index Per Article: 19.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/01/2018] [Accepted: 07/10/2018] [Indexed: 12/12/2022] Open
Affiliation(s)
- Jennifer L Sherr
- Department of Pediatrics, Yale School of Medicine, Yale University, New Haven, Connecticut
| | - Martin Tauschmann
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK.,Department of Paediatrics, University of Cambridge, Cambridge, UK
| | - Tadej Battelino
- UMC-University Children's Hospital, Ljubljana, Slovenia.,Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Martin de Bock
- Department of Paediatrics, University of Otago, Christchurch, New Zealand
| | - Gregory Forlenza
- University of Colorado Denver, Barbara Davis Center, Aurora, Colorado
| | - Rossana Roman
- Medical Sciences Department, University of Antofagasta and Antofagasta Regional Hospital, Antofagasta, Chile
| | - Korey K Hood
- Department of Psychiatry & Behavioral Sciences, Stanford University School of Medicine, Palo Alto, California
| | - David M Maahs
- Department of Pediatrics, Stanford University School of Medicine, Palo Alto, California
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28
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Slover RH, Tryggestad JB, DiMeglio LA, Fox LA, Bode BW, Bailey TS, Brazg R, Christiansen MP, Sherr JL, Tsalikian E, Kaiserman KB, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Continuous Glucose Monitoring System in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther 2018; 20:576-584. [PMID: 30063162 DOI: 10.1089/dia.2018.0109] [Citation(s) in RCA: 21] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/13/2022]
Abstract
BACKGROUND This study evaluated the safety and performance of the Guardian™ continuous glucose monitoring (CGM) system in children and adolescents with type 1 diabetes (T1D). MATERIALS AND METHODS Subjects 2-18 years of age (mean ± standard deviation [SD] 13.1 ± 3.9 years) with T1D and duration of diagnosis ≥1 year were enrolled at 11 sites in the United States and wore two Guardian Sensor 3 sensors in the abdomen and/or buttock. Sensors were connected to a transmitter paired with either a Guardian Connect system (i.e., mobile device with software application allowing display of sensor glucose [SG] values) or a Guardian Link 3 transmitter used as a Glucose Sensor Recorder (GSR). There were 145 participants who underwent a 6-h in-clinic frequent sample testing (FST) on day 1 (n = 54), day 3 (n = 48), or day 7 (n = 43) postsensor insertion. During FST, SG values were compared with a Yellow Springs Instrument (YSI) plasma reference every 5-15 min (n = 124, 7-18 years of age; n = 2, 2-6 years of age), or to a self-monitoring of blood glucose (SMBG) reference every 5-30 min (n = 19, 2-6 years of age). RESULTS The overall mean absolute relative difference (ARD ± SD) between SG and reference values (YSI or SMBG) when calibrating approximately every 12 h, was 10.9% ± 10.7% (3102 paired points) for sensors communicating with the Guardian Connect system and 11.1% ± 10.6% (2624 paired points) for sensors connected to the GSR. The overall percentage of SG values within ±20% of reference values >80 mg/dL or within 20 mg/dL of reference values ≤80 mg/dL was 87.8% for the Guardian Connect system and 86.7% for the GSR, respectively. There was one device-related adverse event of contact dermatitis, but no serious device-related adverse events. CONCLUSIONS The Guardian CGM system demonstrated good accuracy in children and adolescents. These findings support its use in sensor-integrated insulin pump platforms, as well as a standalone technology, for managing diabetes in pediatric populations.
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Affiliation(s)
- Robert H Slover
- 1 Barbara Davis Center for Childhood Diabetes , Aurora, Colorado
| | - Jeanie B Tryggestad
- 2 Oklahoma University Health Sciences Center , Department of Pediatrics, Oklahoma City, Oklahoma
| | | | - Larry A Fox
- 4 Nemours Children's Health System , Jacksonville, Florida
| | - Bruce W Bode
- 5 Atlanta Diabetes Associates , Atlanta, Georgia
| | | | - Ronald Brazg
- 7 Rainier Clinical Research Center , Renton, Washington
| | | | - Jennifer L Sherr
- 9 Yale University School of Medicine , Pediatric Endocrinology, New Haven, Connecticut
| | - Eva Tsalikian
- 10 University of Iowa , Department of Pediatrics, Iowa City, Iowa
| | | | | | | | - John Shin
- 12 Medtronic , Northridge, California
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29
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García-Lorenzo B, Rivero-Santana A, Vallejo-Torres L, Castilla-Rodríguez I, García-Pérez S, García-Pérez L, Perestelo-Pérez L. Cost-effectiveness analysis of real-time continuous monitoring glucose compared to self-monitoring of blood glucose for diabetes mellitus in Spain. J Eval Clin Pract 2018; 24:772-781. [PMID: 29971893 DOI: 10.1111/jep.12987] [Citation(s) in RCA: 20] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/24/2018] [Revised: 06/11/2018] [Accepted: 06/13/2018] [Indexed: 12/13/2022]
Abstract
RATIONALE, AIMS AND OBJECTIVES Self-monitoring of blood glucose (SMBG) is recommended to monitor glycaemic levels. The recent development of real-time continuous glucose monitoring (RT-CGM) enables continuous display of glucose concentration alerting patients in the event of relevant glucose fluctuations, potentially avoiding hypoglycaemic events and reducing long-term complications related to glycosylated haemoglobin (HbA1c) levels. This paper aims to evaluate the cost-effectiveness of RT-CGM compared to SMBG in patients with type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) which should support decision-making on public funding of RT-CGM in Spain. METHODS We performed a systematic review and meta-analyses on the effectiveness of RT-CGM in the reduction of HbA1c levels and severe hypoglycaemic events. A cost-effectiveness analysis was conducted using a Markov model which simulates the costs and health outcomes of individuals treated under these alternatives for a lifetime horizon from the perspective of the Spanish Health Service. The effectiveness measure was quality-adjusted life years (QALYs). We ran extensive sensitivity analyses, including a probabilistic sensitivity analysis. RESULTS Real-time continuous glucose monitoring provides a significant reduction of HbA1c for T1DM (13 studies; weighted mean difference (WMD) = -0.23%, 95% CI: -0.35, -0.11) and T2DM (5 studies; WMD = -0.48%, 95% CI: -0.79, -0.17). There were no statistically significant differences in the rate of severe hypoglycaemic events in T1DM (9 studies; OR = 1.16, 95% CI: 0.78, 1.72) or T2DM (no severe hypoglycaemic events were reported in any study). In the base case analysis, RT-CGM led to higher QALYs and health care costs with an estimated incremental cost-effectiveness ratio of €2 554 723 and €180 553 per QALY for T1DM and T2DM patients respectively. Sensitivity analyses revealed that the study results were robust. CONCLUSIONS Real-time continuous glucose monitoring is not a cost-effective technology when compared to SMBG in Spain.
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Affiliation(s)
- Borja García-Lorenzo
- Fundación Canaria de Investigación Sanitaria (FUNCANIS), Las Palmas de Gran Canaria, Spain.,Universitat Internacional de Catalunya (UIC), Barcelona, Spain.,Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, Spain
| | - Amado Rivero-Santana
- Fundación Canaria de Investigación Sanitaria (FUNCANIS), Las Palmas de Gran Canaria, Spain.,Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, Spain.,Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Santa Cruz de Tenerife, Spain
| | - Laura Vallejo-Torres
- Fundación Canaria de Investigación Sanitaria (FUNCANIS), Las Palmas de Gran Canaria, Spain.,Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, Spain.,Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Santa Cruz de Tenerife, Spain.,Departamento de Métodos Cuantitativo en Economía y Gestión, Universidad de Las Palmas de Gran Canaria, Spain
| | - Iván Castilla-Rodríguez
- Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Santa Cruz de Tenerife, Spain.,Departamento de Ingeniería Informática y de Sistemas, Universidad de La Laguna, San Cristóbal de La Laguna, Spain
| | - Sonia García-Pérez
- Agencia Española del Medicamento y Productos Sanitarios (AEMPS), Madrid, Spain.,Instituto Carlos III de la Salud, Madrid, Spain
| | - Lidia García-Pérez
- Fundación Canaria de Investigación Sanitaria (FUNCANIS), Las Palmas de Gran Canaria, Spain.,Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, Spain.,Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Santa Cruz de Tenerife, Spain
| | - Lilisbeth Perestelo-Pérez
- Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Santa Cruz de Tenerife, Spain.,Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Santa Cruz de Tenerife, Spain.,Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Santa Cruz de Tenerife, Spain
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30
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Majeed W, Thabit H. Closed-loop insulin delivery: current status of diabetes technologies and future prospects. Expert Rev Med Devices 2018; 15:579-590. [PMID: 30027775 DOI: 10.1080/17434440.2018.1503530] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
INTRODUCTION Type 1 diabetes is characterised by destruction of pancreatic beta cells, leading to insulin deficiency and hyperglycaemia. The mainstay of treatment remains lifelong insulin therapy as a sustainable cure has as yet proven elusive. The burden of daily management of type 1 diabetes has contributed to suboptimal outcomes for people living with the condition. Innovative technological approaches have been shown to improve glycaemic and patient-related outcomes. AREAS COVERED We discuss recent advances in technologies in type 1 diabetes including closed-loop systems, also known as the 'artificial pancreas. Its various components, technical aspects and limitations are reviewed. We also discuss its advent into clinical practice, and other systems in development. Evidence from clinical studies are summarised. EXPERT COMMENTARY The recent approval of a hybrid closed-loop system for clinical use highlights the significant progress made in this field. Results from clinical studies have shown safety and glycaemic benefit, however challenges remain around improving performance and acceptability. More data is required to establish long-term clinical efficacy and cost-effectiveness, to fulfil the expectations of people with type 1 diabetes.
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Affiliation(s)
- Waseem Majeed
- a Manchester Academic Health Science Centre , Manchester University Hospitals NHS Foundation Trust , Manchester , UK
| | - Hood Thabit
- a Manchester Academic Health Science Centre , Manchester University Hospitals NHS Foundation Trust , Manchester , UK.,b Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health , University of Manchester , Manchester , UK
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Matsuoka A, Hirota Y, Urai S, Hamaguchi T, Takeuchi T, Miura H, Suematsu N, So A, Nakamura T, Komada H, Okada Y, Sakaguchi K, Ogawa W. Effect of switching from conventional continuous subcutaneous insulin infusion to sensor augmented pump therapy on glycemic profile in Japanese patients with type 1 diabetes. Diabetol Int 2018; 9:201-207. [PMID: 30603368 PMCID: PMC6224909 DOI: 10.1007/s13340-018-0344-4] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/23/2017] [Accepted: 01/05/2018] [Indexed: 10/18/2022]
Abstract
AIMS Evidence suggests that sensor augmented pump (SAP) therapy is superior to conventional continuous subcutaneous insulin infusion (CSII) for achieving glycemic control in patients with type 1 diabetes. However, the clinical benefit of SAP therapy in East Asians has not yet been demonstrated. METHODS The effect of switching from conventional CSII to SAP therapy on glycemic profile was examined in 18 Japanese patients with type 1 diabetes. The glycemic profile of the patients was determined by retrospective continuous glucose monitoring (CGM) within 1 month before the treatment switch, whereas that at 6 and 12 months after the switch was evaluated with the CGM function of the SAP device. Hemoglobin A1c levels were also measured before and after the switch to SAP therapy. RESULTS The duration of hypoglycemia was significantly decreased at both 6 and 12 months after the change in treatment (6.6 ± 4.5, 3.2 ± 4.1, and 3.0 ± 2.8 min/h for before and 6 and 12 months, respectively), as was the HbA1c level at 12 months (7.8 ± 1.0 and 7.4 ± 0.9%, respectively). The duration of hyperglycemia did not differ between before and after the treatment switch. The decline in HbA1c level at 12 months after the switch to SAP was negatively correlated with age. CONCLUSION Switching from conventional CSII to SAP therapy was associated with a decrease in both the duration of hypoglycemia and the level of HbA1c in Japanese patients with type 1 diabetes.
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Affiliation(s)
- Atsuko Matsuoka
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Yushi Hirota
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Shin Urai
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Tetsushi Hamaguchi
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Takehito Takeuchi
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Hiroshi Miura
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Natsu Suematsu
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Anna So
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Tomoaki Nakamura
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Hisako Komada
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Yuko Okada
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Kazuhiko Sakaguchi
- Division of General Internal Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
| | - Wataru Ogawa
- Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, 650-0017 Japan
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Moreno-Fernandez J, Pazos-Couselo M, González-Rodriguez M, Rozas P, Delgado M, Aguirre M, Garcia-Lopez JM. Clinical value of Flash glucose monitoring in patients with type 1 diabetes treated with continuous subcutaneous insulin infusion. ACTA ACUST UNITED AC 2018; 65:556-563. [PMID: 29907546 DOI: 10.1016/j.endinu.2018.04.003] [Citation(s) in RCA: 14] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/25/2017] [Revised: 03/02/2018] [Accepted: 04/13/2018] [Indexed: 11/26/2022]
Abstract
AIM To analyze the clinical impact of the Flash glucose monitoring system in patients with type 1 diabetes mellitus (T1DM) treated with continuous subcutaneous insulin infusion (CSII). METHODS A 24-week retrospective cohort study in CSII-treated T1DM patients exposed (1:1) to the Flash glucose monitoring system vs. self-monitoring of capillary blood glucose (SMBG). The primary outcome was the difference in hemoglobin A1c (HbA1c) levels between both groups at the end of the study. RESULTS Thirty-six patients with a mean age of 38.2 years (range 22-55) and a mean T1DM duration of 20.9±7.8 years, treated with CSII for 7.1±5.4 years, were enrolled into the study. At the end of the study, mean HbA1c levels improved in patients in the Flash group (7.1±0.7 vs. 7.8±1.0, p=0.04). Only the Flash group showed a significant decrease in HbA1c levels of -0.4% (95% CI, -0.6, -0.2; p=0.004) during follow-up. Flash patients captured 93.9% of data through 17.8±9.9 scans daily. In fact, the Flash cohort showed a three-fold increase in daily self-monitoring of glucose, while daily frequency of SMBG decreased during the study (-1.8 tests/24h (95% CI -3, -0.7; p=0.01). No safety issues related to Flash use were recorded. CONCLUSIONS The Flash glucose monitoring system is a novel approach to improve blood glucose control in CSII-treated T1DM patients. Randomized controlled trials are needed to assess the effectiveness of this system in CSII-treated T1DM patients.
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Affiliation(s)
- Jesus Moreno-Fernandez
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain.
| | - Marcos Pazos-Couselo
- Endocrinology and Nutrition Service, Hospital Complex Santiago de Compostela, Santiago de Compostela, Spain
| | - Maria González-Rodriguez
- Endocrinology and Nutrition Service, Hospital Complex Santiago de Compostela, Santiago de Compostela, Spain
| | - Pedro Rozas
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - Manuel Delgado
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - Miguel Aguirre
- Endocrinology and Nutrition Service, Ciudad Real General University Hospital, Ciudad Real, Spain
| | - Jose Manuel Garcia-Lopez
- Endocrinology and Nutrition Service, Hospital Complex Santiago de Compostela, Santiago de Compostela, Spain
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Yu S, Varughese B, Li Z, Kushner PR. Healthcare Resource Waste Associated with Patient Nonadherence and Early Discontinuation of Traditional Continuous Glucose Monitoring in Real-World Settings: A Multicountry Analysis. Diabetes Technol Ther 2018; 20:420-427. [PMID: 29923774 PMCID: PMC6014049 DOI: 10.1089/dia.2017.0435] [Citation(s) in RCA: 16] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
Abstract
BACKGROUND Traditional continuous glucose monitoring (CGM) provides detailed information on glucose patterns and trends to inform daily diabetes management decisions, which is particularly beneficial for patients with a history of hypoglycemia unawareness. However, a high level of patient adherence (≥70%) is required to achieve clinical benefits. The aim of this study was to assess the impact of real-world patient nonadherence and early discontinuation on healthcare resource use. METHODS A cost calculator was designed to evaluate monthly healthcare resource waste within the first year of traditional CGM initiation by combining estimates of real-world nonadherence and early discontinuation from the literature with the wholesale acquisition costs of the current technology in the United States (for a commercial payer and for Medicare), or its equivalent in Sweden, Germany, or the Netherlands. RESULTS Based on an early discontinuation rate of 27% and nonadherence rates of 13.9%-31.1% over the 12 months following initiation, the healthcare resource waste associated with nonadherence and early discontinuation was $220,289 and $21,775, respectively, for every 100 patients initiating CGM in the U.S. commercial payer scenario. In the Medicare scenario, the corresponding figures were $72,648 and $5,675, respectively. In both scenarios, nonadherence and early discontinuation accounted for ∼24% of resources being wasted within the first year of CGM initiation. Similar results were observed using the local costs in the other countries analyzed. CONCLUSIONS The healthcare resource waste associated with traditional CGM nonadherence and early discontinuation warrants deliberate consideration when selecting suitable patients for this technology.
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Affiliation(s)
| | | | - Zhiyi Li
- Asclepius Analytics, New York, New York
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Ilany J, Bhandari H, Nabriski D, Toledano Y, Konvalina N, Cohen O. Effect of prandial treatment timing adjustment, based on continuous glucose monitoring, in patients with type 2 diabetes uncontrolled with once-daily basal insulin: A randomized, phase IV study. Diabetes Obes Metab 2018; 20:1186-1192. [PMID: 29316176 PMCID: PMC5947685 DOI: 10.1111/dom.13214] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/18/2017] [Revised: 12/25/2017] [Accepted: 12/25/2017] [Indexed: 12/16/2022]
Abstract
AIMS To evaluate the glycaemic control achieved by prandial once-daily insulin glulisine injection timing adjustment, based on a continuous glucose monitoring sensor, in comparison to once-daily insulin glulisine injection before breakfast in patients with type 2 diabetes who are uncontrolled with once-daily basal insulin glargine. MATERIALS AND METHODS This was a 24-week open-label, randomized, controlled, multicentre trial. At the end of an 8-week period of basal insulin optimization, patients with HbA1c ≥ 7.5% and FPG < 130 mg/dL were randomized (1:1) to either arm A (no sensor) or arm B (sensor) to receive 16-week intensified prandial glulisine treatment. Patients in arm A received pre-breakfast glulisine, and patients in arm B received glulisine before the meal with the highest glucose elevation based on sensor data. The primary outcome was mean HbA1c at week 24 and secondary outcomes included rates of hypoglycaemic events and insulin dosage. RESULTS A total of 121 patients were randomized to arm A (n = 61) or arm B (n = 60). There was no difference in mean HbA1c at week 24 between arms A and B (8.5% ± 1.2% vs 8.4% ± 1.0%; P = .66). The prandial insulin glulisine dosage for arm A and arm B was 9.3 and 10.1 units, respectively (P = .39). The frequency of hypoglycaemic events did not differ between study arms (36.1% vs 51.7%; P = .08). CONCLUSION Using a CGM sensor to identify the meal with the highest glucose excursion and adjusting the timing of prandial insulin treatment did not show any advantage in terms of glycaemic control or safety in our patients.
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Affiliation(s)
- Jacob Ilany
- Institute of Endocrinology, Sheba MCRamat‐GannIsrael
| | | | - Dan Nabriski
- Endocrine Unit, Meir MC, Clalit Health FundKfar‐SabaIsrael
| | | | - Noa Konvalina
- Institute of Endocrinology, Sheba MCRamat‐GannIsrael
| | - Ohad Cohen
- Institute of Endocrinology, Sheba MCRamat‐GannIsrael
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Choudhary P, Amiel SA. Hypoglycaemia in type 1 diabetes: technological treatments, their limitations and the place of psychology. Diabetologia 2018; 61:761-769. [PMID: 29423581 PMCID: PMC6448988 DOI: 10.1007/s00125-018-4566-6] [Citation(s) in RCA: 29] [Impact Index Per Article: 4.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/17/2017] [Accepted: 12/21/2017] [Indexed: 01/16/2023]
Abstract
Advances in technology allowing improved insulin delivery and glucose monitoring can significantly reduce the burden of hypoglycaemia when used appropriately. However, limitations of the current technology, and the skills, commitment and motivation required to use them, mean that it does not work for all people. Education and informed professional support are key to success. In the context of problematic hypoglycaemia, data suggest that newer technology has lower efficacy and uptake in those with most need. Identifying the causes of hypoglycaemia and understanding some of the underlying behavioural drivers may prove useful and psycho-educational strategies may be effective in selected individuals. Ultimately, as in many spheres of medicine, successful management of problematic hypoglycaemia depends upon matching the right treatment to the right individual.
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Affiliation(s)
- Pratik Choudhary
- Diabetes Research Group, School of Life Course Sciences, Weston Education Centre, King's College London, 10 Cutcombe Road, London, SE5 9RJ, UK
- Department of Diabetes, King's College Hospital Foundation Trust, London, UK
| | - Stephanie A Amiel
- Diabetes Research Group, School of Life Course Sciences, Weston Education Centre, King's College London, 10 Cutcombe Road, London, SE5 9RJ, UK.
- Department of Diabetes, King's College Hospital Foundation Trust, London, UK.
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Christiansen MP, Klaff LJ, Brazg R, Chang AR, Levy CJ, Lam D, Denham DS, Atiee G, Bode BW, Walters SJ, Kelley L, Bailey TS. A Prospective Multicenter Evaluation of the Accuracy of a Novel Implanted Continuous Glucose Sensor: PRECISE II. Diabetes Technol Ther 2018; 20:197-206. [PMID: 29381090 PMCID: PMC5867508 DOI: 10.1089/dia.2017.0142] [Citation(s) in RCA: 88] [Impact Index Per Article: 12.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/04/2023]
Abstract
BACKGROUND Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHODS PRECISE II was a nonrandomized, blinded, prospective, single-arm, multicenter study that evaluated the accuracy and safety of the implantable Eversense CGM system among adult participants with T1D and T2D (NCT02647905). The primary endpoint was the mean absolute relative difference (MARD) between paired Eversense and Yellow Springs Instrument (YSI) reference measurements through 90 days postinsertion for reference glucose values from 40 to 400 mg/dL. Additional endpoints included Clarke Error Grid analysis and sensor longevity. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related serious adverse events (SAEs) through 90 days postinsertion. RESULTS Ninety participants received the CGM system. The overall MARD value against reference glucose values was 8.8% (95% confidence interval: 8.1%-9.3%), which was significantly lower than the prespecified 20% performance goal for accuracy (P < 0.0001). Ninety-three percent of CGM values were within 20/20% of reference values over the total glucose range of 40-400 mg/dL. Clarke Error Grid analysis showed 99.3% of samples in the clinically acceptable error zones A (92.8%) and B (6.5%). Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. CONCLUSIONS The PRECISE II trial demonstrated that the Eversense CGM system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile.
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Affiliation(s)
| | | | - Ronald Brazg
- Rainier Clinical Research Center, Inc., Renton, Washington
| | - Anna R. Chang
- John Muir Physician Network Clinical Research Center, Concord, California
| | - Carol J. Levy
- Department of Medicine, Mount Sinai Diabetes Center, New York, New York
| | - David Lam
- Department of Medicine, Mount Sinai Diabetes Center, New York, New York
| | | | | | | | - Steven J. Walters
- Clinical Sciences and Medical Affairs, Senseonics, Inc., Germantown, Maryland
| | - Lynne Kelley
- Clinical Sciences and Medical Affairs, Senseonics, Inc., Germantown, Maryland
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Iqbal A, Novodvorsky P, Heller SR. Recent Updates on Type 1 Diabetes Mellitus Management for Clinicians. Diabetes Metab J 2018; 42:3-18. [PMID: 29504302 PMCID: PMC5842299 DOI: 10.4093/dmj.2018.42.1.3] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.7] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2018] [Accepted: 01/31/2018] [Indexed: 01/11/2023] Open
Abstract
Type 1 diabetes mellitus (T1DM) is a chronic autoimmune condition that requires life-long administration of insulin. Optimal management of T1DM entails a good knowledge and understanding of this condition both by the physician and the patient. Recent introduction of novel insulin preparations, technological advances in insulin delivery and glucose monitoring, such as continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring and improved understanding of the detrimental effects of hypoglycaemia and hyperglycaemia offer new opportunities and perspectives in T1DM management. Evidence from clinical trials suggests an important role of structured patient education. Our efforts should be aimed at improved metabolic control with concomitant reduction of hypoglycaemia. Despite recent advances, these goals are not easy to achieve and can put significant pressure on people with T1DM. The approach of physicians should therefore be maximally supportive. In this review, we provide an overview of the recent advances in T1DM management focusing on novel insulin preparations, ways of insulin administration and glucose monitoring and the role of metformin or sodium-glucose co-transporter 2 inhibitors in T1DM management. We then discuss our current understanding of the effects of hypoglycaemia on human body and strategies aimed at mitigating the risks associated with hypoglycaemia.
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Affiliation(s)
- Ahmed Iqbal
- Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
- Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK
| | - Peter Novodvorsky
- Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
| | - Simon R Heller
- Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK
- Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
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Sheikh K, Bartz SK, Lyons SK, DeSalvo DJ. Diabetes Device Use and Glycemic Control among Youth with Type 1 Diabetes: A Single-Center, Cross-Sectional Study. J Diabetes Res 2018; 2018:5162162. [PMID: 30151393 PMCID: PMC6087575 DOI: 10.1155/2018/5162162] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2018] [Accepted: 06/11/2018] [Indexed: 01/06/2023] Open
Abstract
AIM The purpose of this cross-sectional study was to determine the rates of diabetes device use (insulin pump and continuous glucose monitor (CGM)) and association with glycemic control in youth with type 1 diabetes in a large, diverse pediatric center. METHODS Demographic and clinical data were obtained from 1992 patients who met the eligibility criteria (age < 26 years, diabetes duration ≥ 1 year, and ≥1 clinic visit in the preceding 12 months). Statistical analyses assessed the likelihood of device use based on demographic characteristics and the association between device use and glycemic control based on most recent hemoglobin A1c (HbA1c). RESULTS Mean age was 13.8 ± 4.2 years, 50.7% were female, diabetes duration was 6.2 ± 4 years, and mean HbA1c was 8.7 ± 1.8%. Overall, 38.2% of patients were on pump therapy and 18.5% were on CGM. Patients who were non-Hispanic (NH) white, privately insured, and with primary English-speaking parent(s) had higher rates of insulin pump use, as well as CGM use (P < 0.001 for both). Female patients had higher rates of pump use only (P < 0.01). Private health insurance, NH white race/ethnicity, and CGM use were each associated with lower HbA1c (P = 0.03, <0.001, and <0.008, resp.). CONCLUSION At a large, diverse, pediatric diabetes center, disparities in diabetes device use were present across sex, race/ethnicity, health insurance coverage, and primary language of parent(s). CGM use was associated with lower HbA1c. Quality improvement efforts are underway to ensure improved access, education, and clinical programs for advanced diabetes devices for T1D patients.
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Affiliation(s)
| | - Sara K. Bartz
- Baylor College of Medicine/Texas Children's Hospital, Houston, TX, USA
| | - Sarah K. Lyons
- Baylor College of Medicine/Texas Children's Hospital, Houston, TX, USA
| | - Daniel J. DeSalvo
- Baylor College of Medicine/Texas Children's Hospital, Houston, TX, USA
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Rickels MR, Peleckis AJ, Dalton-Bakes C, Naji JR, Ran NA, Nguyen HL, O’Brien S, Chen S, Lee I, Schutta MH. Continuous Glucose Monitoring for Hypoglycemia Avoidance and Glucose Counterregulation in Long-Standing Type 1 Diabetes. J Clin Endocrinol Metab 2018; 103:105-114. [PMID: 29190340 PMCID: PMC6283439 DOI: 10.1210/jc.2017-01516] [Citation(s) in RCA: 48] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/06/2017] [Accepted: 10/10/2017] [Indexed: 11/19/2022]
Abstract
CONTEXT Patients with long-standing type 1 diabetes (T1D) are at increased risk for severe hypoglycemia because of defects in glucose counterregulation and recognition of hypoglycemia symptoms, in part mediated through exposure to hypoglycemia. OBJECTIVE To determine whether implementation of real-time continuous glucose monitoring (CGM) as a strategy for hypoglycemia avoidance could improve glucose counterregulation in patients with long-standing T1D and hypoglycemia unawareness. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTION Eleven patients with T1D disease duration of ∼31 years were studied longitudinally in the Clinical & Translational Research Center of the University of Pennsylvania before and 6 and 18 months after initiation of CGM and were compared with 12 nondiabetic control participants. MAIN OUTCOME MEASURE Endogenous glucose production response derived from paired hyperinsulinemic stepped-hypoglycemic and euglycemic clamps with infusion of 6,6-2H2-glucose. RESULTS In patients with T1D, hypoglycemia awareness (Clarke score) and severity (HYPO score and severe events) improved (P < 0.01 for all) without change in hemoglobin A1c (baseline, 7.2% ± 0.2%). In response to insulin-induced hypoglycemia, endogenous glucose production did not change from before to 6 months (0.42 ± 0.08 vs 0.54 ± 0.07 mg·kg-1·min-1) but improved after 18 months (0.84 ± 0.15 mg·kg-1·min-1; P < 0.05 vs before CGM), albeit remaining less than in controls (1.39 ± 0.11 mg·kg-1·min-1; P ≤ 0.01 vs all). CONCLUSIONS Real-time CGM can improve awareness and reduce the burden of problematic hypoglycemia in patients with long-standing T1D, but with only modest improvement in the endogenous glucose production response that is required to prevent or correct low blood glucose.
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Affiliation(s)
- Michael R Rickels
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
- Correspondence and Reprint Requests: Michael R. Rickels, MD, MS, Perelman School of Medicine at the University of Pennsylvania, 12-134 Translational Research Center, 3400 Civic Center Boulevard, Philadelphia, Pennsylvania 19104. E-mail:
| | - Amy J Peleckis
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Cornelia Dalton-Bakes
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Joseph R Naji
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Nina A Ran
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Huong-Lan Nguyen
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Shannon O’Brien
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Sanjian Chen
- Department of Computer and Information Science, School of Engineering and Applied Science, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Insup Lee
- Department of Computer and Information Science, School of Engineering and Applied Science, University of Pennsylvania, Philadelphia, Pennsylvania
| | - Mark H Schutta
- Department of Medicine, Division of Endocrinology, Diabetes & Metabolism, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania
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Cordero TL, Garg SK, Brazg R, Bailey TS, Shin J, Lee SW, Kaufman FR. The Effect of Prior Continuous Glucose Monitoring Use on Glycemic Outcomes in the Pivotal Trial of the MiniMed ™ 670G Hybrid Closed-Loop System. Diabetes Technol Ther 2017; 19:749-752. [PMID: 29148821 DOI: 10.1089/dia.2017.0208] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/12/2022]
Abstract
A 3-month pivotal trial using the MiniMed™ 670G hybrid closed-loop (HCL) system in adolescent and adult patients with type 1 diabetes (T1D), relative to a 2-week baseline run-in period, resulted in increased sensor glucose (SG) values in target range (71-180 mg/dL), reduced HbA1c levels, and no events of diabetic ketoacidosis or severe hypoglycemia ( Clinicaltrials.gov : NCT02463097). This brief report evaluated how prior continuous glucose monitoring (CGM) experience influenced glycemic outcomes, in the same pivotal trial. HbA1c levels and the percentage of SG values in low, high, and in-target ranges were analyzed from participants (n = 124) completing the Hybrid Closed-Loop Pivotal Trial in T1D. There were 78 individuals comprising the prior CGM group and 46 comprising the no prior CGM group. Compared to baseline, HbA1c was reduced from 7.4% ± 0.9% to 6.9% ± 0.7% for the prior CGM group and from 7.5% ± 0.9% to 6.8% ± 0.5% for the no prior CGM group. For those with prior CGM experience, the mean percentage of in-target SG values increased from 66.9% ± 12.5% to 72.6% ± 9.1%, and for those with no prior CGM experience it increased from 66.6% ± 11.7% to 71.5% ± 8.5%. Similar improvement in glucose values in the low and high ranges, relative to baseline, was observed for both groups. Resulting outcomes, from baseline to study end, did not differ between each group. These findings suggest that individuals without prior CGM experience, and those already using CGM, will benefit similarly with use of the FDA-approved MiniMed 670G HCL system therapy.
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Affiliation(s)
| | - Satish K Garg
- 2 Barbara Davis Center for Diabetes , Aurora, Colorado
| | - Ronald Brazg
- 3 Rainier Clinical Research Center , Renton, Washington
| | | | - John Shin
- 1 Medtronic , Northridge, California
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Klonoff DC, Ahn D, Drincic A. Continuous glucose monitoring: A review of the technology and clinical use. Diabetes Res Clin Pract 2017; 133:178-192. [PMID: 28965029 DOI: 10.1016/j.diabres.2017.08.005] [Citation(s) in RCA: 150] [Impact Index Per Article: 18.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/14/2017] [Revised: 06/27/2017] [Accepted: 08/08/2017] [Indexed: 02/01/2023]
Abstract
Continuous glucose monitoring (CGM) is an increasingly adopted technology for insulin-requiring patients that provides insights into glycemic fluctuations. CGM can assist patients in managing their diabetes with lifestyle and medication adjustments. This article provides an overview of the technical and clinical features of CGM based on a review of articles in PubMed on CGM from 1999 through January 31, 2017. A detailed description is presented of three professional (retrospective), three personal (real-time) continuous glucose monitors, and three sensor integrated pumps (consisting of a sensor and pump that communicate with each other to determine an optimal insulin dose and adjust the delivery of insulin) that are currently available in United States. We have reviewed outpatient CGM outcomes, focusing on hemoglobin A1c (A1C), hypoglycemia, and quality of life. Issues affecting accuracy, detection of glycemic variability, strategies for optimal use, as well as cybersecurity and future directions for sensor design and use are discussed. In conclusion, CGM is an important tool for monitoring diabetes that has been shown to improve outcomes in patients with type 1 diabetes mellitus. Given currently available data and technological developments, we believe that with appropriate patient education, CGM can also be considered for other patient populations.
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Affiliation(s)
- David C Klonoff
- Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA.
| | - David Ahn
- University of California, Los Angeles, Los Angeles, CA, USA
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Gómez AM, Henao Carrillo DC, Muñoz Velandia OM. Devices for continuous monitoring of glucose: update in technology. MEDICAL DEVICES-EVIDENCE AND RESEARCH 2017; 10:215-224. [PMID: 28979168 PMCID: PMC5602456 DOI: 10.2147/mder.s110121] [Citation(s) in RCA: 13] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/14/2022] Open
Abstract
Continuous glucose monitoring (CGM) is a tool that allows constant evaluation of glycemic control, providing data such as the trend and fluctuation of interstitial glucose levels over time. In clinical practice, there are two modalities: the professional or retrospective and the personal or real-time CGM (RT-CGM). The latest-generation sensors are more accurate and sensitive for hypoglycemia, improving adherence to self-monitoring, which has allowed optimizing glycemic control. The development of algorithms that allow the suspension of the infusion of insulin during hypoglycemia gave rise to the integrated therapy or sensor-augmented insulin pump therapy with low glucose suspend, which has proven to be an effective and safe alternative in the treatment of diabetic patients with high risk of hypoglycemia. The objective of this review is to present the evidence of the advantages of RT-CGM, the clinical impact of integrated therapy, and cost-effectiveness of its implementation in the treatment of patients with diabetes mellitus.
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Affiliation(s)
- Ana María Gómez
- Endocrinology Unit, Hospital Universitario San Ignacio, Bogotá, Colombia
| | | | - Oscar Mauricio Muñoz Velandia
- Department of Internal Medicine, Hospital Universitario San Ignacio, Bogotá, Colombia.,Department of Clinical Epidemiology, Pontificia Universidad Javeriana, Faculty of Medicine, Bogotá, Colombia
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Christiansen MP, Garg SK, Brazg R, Bode BW, Bailey TS, Slover RH, Sullivan A, Huang S, Shin J, Lee SW, Kaufman FR. Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor. Diabetes Technol Ther 2017; 19:446-456. [PMID: 28700272 PMCID: PMC5567873 DOI: 10.1089/dia.2017.0087] [Citation(s) in RCA: 86] [Impact Index Per Article: 10.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/14/2022]
Abstract
BACKGROUND This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian™ Sensor 3) in the abdomen and arm. METHODS Eighty-eight subjects (14-75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensors in the abdomen that were paired with either a MiniMed™ 640G insulin pump, or an iPhone® or iPod® touch® running a glucose monitoring mobile application (Guardian Connect system) and a third sensor in the arm, which was connected to a glucose sensor recorder (GSR). Subjects were also asked to undergo in-clinic visits of 12-14 h on study days 1, 3, and 7 for frequent blood glucose sample testing using a Yellow Springs Instrument (YSI) reference. RESULTS The overall mean absolute relative difference (MARD ± SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% ± 9.0% and 9.4% ± 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% ± 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI >80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Mean functional sensor life, when calibrating 3-4 times/day, was 145.9 ± 39.3 h for sensors paired with the MiniMed 640G insulin pump, 146.1 ± 41.6 h for sensors paired with the Guardian Connect system, and 147.6 ± 40.4 h for sensors connected to the GSR. Responses to survey questions regarding sensor comfort and ease of use were favorable. CONCLUSIONS The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use. ClinicalTrials.gov : NCT02246582.
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Affiliation(s)
| | | | - Ronald Brazg
- Rainier Clinical Research Center, Renton, Washington
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Schnell O, Barnard K, Bergenstal R, Bosi E, Garg S, Guerci B, Haak T, Hirsch IB, Ji L, Joshi SR, Kamp M, Laffel L, Mathieu C, Polonsky WH, Snoek F, Home P. Role of Continuous Glucose Monitoring in Clinical Trials: Recommendations on Reporting. Diabetes Technol Ther 2017; 19:391-399. [PMID: 28530490 PMCID: PMC5695750 DOI: 10.1089/dia.2017.0054] [Citation(s) in RCA: 42] [Impact Index Per Article: 5.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/20/2023]
Abstract
Thanks to significant improvements in the precision, accuracy, and usability of continuous glucose monitoring (CGM), its relevance in both ambulatory diabetes care and clinical research is increasing. In this study, we address the latter perspective and derive provisional reporting recommendations. CGM systems have been available since around the year 2000 and used primarily in people with type 1 diabetes. In contrast to self-measured glucose, CGM can provide continuous real-time measurement of glucose levels, alerts for hypoglycemia and hyperglycemia, and a detailed assessment of glycemic variability. Through a broad spectrum of derived glucose data, CGM should be a useful tool for clinical evaluation of new glucose-lowering medications and strategies. It is the only technology that can measure hyperglycemic and hypoglycemic exposure in ambulatory care, or provide data for comprehensive assessment of glucose variability. Other advantages of current CGM systems include the opportunity for improved self-management of glycemic control, with particular relevance to those at higher risk of or from hypoglycemia. We therefore summarize the current status and limitations of CGM from the perspective of clinical trials and derive suggested recommendations for how these should facilitate optimal CGM use and reporting of data in clinical research.
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Affiliation(s)
- Oliver Schnell
- Forschergruppe Diabetes e.V., Helmholtz Zentrum, Munich, Germany
| | - Katharine Barnard
- Bournemouth University, Faculty of Health and Social Science, Bournemouth, United Kingdom
| | | | - Emanuele Bosi
- Vita-Salute San Raffaele University, Department of General Medicine-Diabetes & Endocrinology Unit, Milan, Italy
| | - Satish Garg
- Barbara Davis Center for Diabetes, University of Colorado Denver, Denver, Colorado
| | - Bruno Guerci
- Centre Hospitalier Universitaire Nancy, Vandoeuvre-Les-Nancy, France
| | - Thomas Haak
- Diabetes Center Mergentheim, Bad Mergentheim, Germany
| | - Irl B. Hirsch
- University of Washington School of Medicine, Division of Metabolism, Endocrinology and Nutrition, Seattle, Washington
| | - Linong Ji
- Department of Endocrinology and Metabolism, Peking University People's Hospital, Peking, China
| | | | - Maarten Kamp
- Queensland University of Technology, Faculty of Health, Brisbane, Australia
| | - Lori Laffel
- Joslin Diabetes Center, Section on Pediatric, Adolescent and Young Adult Diabetes, Boston, Massachusetts
| | - Chantal Mathieu
- University Hospital Gasthuisberg Leuven, Department of Clinical and Experimental Medicine, Leuven, Belgium
| | - William H. Polonsky
- Behavioral Diabetes Institute, University of California, San Diego, San Diego, California
| | - Frank Snoek
- Department of Medical Psychology, VU University Medical Center and Academic Medical Center, Amsterdam, The Netherlands
| | - Philip Home
- Institute of Cellular Medicine – Diabetes, Newcastle University, Newcastle upon Tyne, United Kingdom
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Fox LA, Balkman E, Englert K, Hossain J, Mauras N. Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly controlled type 1 diabetes mellitus: a pilot study. Pediatr Diabetes 2017; 18:271-276. [PMID: 27435145 PMCID: PMC5250611 DOI: 10.1111/pedi.12404] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/01/2016] [Revised: 04/15/2016] [Accepted: 05/30/2016] [Indexed: 12/20/2022] Open
Abstract
BACKGROUND This study explored the safety of using real-time sensor glucose (SG) data for treatment decisions in adolescents with poorly controlled type 1 diabetes. METHODS Ten adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center and a continuous glucose sensor was inserted. Plasma glucose was measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. Starting at dinner, SG rather than YSI was used for treatment decisions unless YSI was <70 mg/dL (<3.9 mmol/L) or specific criteria indicating SG and YSI were very discordant were met. Participants were discharged after lunch the next day. RESULTS Ten participants (seven males; 15.2-17.8 year old) completed the study. The range of differences between high glucose correction doses using SG vs YSI for calculations was -2 (SG < YSI dose) to +1 (SG > YSI dose); this difference was two units in only 2 of 23 correction doses given (all SG < YSI dose). There were five episodes of mild hypoglycemia in two patients, two of which occurred after using SG for dose calculations. There was no severe hypoglycemia and no YSI glucose >350 mg/dL (19.4 mmol/L). Mean (±SE) pre- and postmeal YSI glucose were 163 ± 11 and 183 ± 12 mg/dL (9.1 ± 0.6 and 10.2 ± 0.7 mmol/L), respectively. CONCLUSION Use of real-time continuous glucose monitoring for treatment decisions was safe and did not result in significant over- or undertreatment. Use of SG for treatment decisions under supervised inpatient conditions is a suitable alternative to repeated fingerstick glucose monitoring. Outpatient studies using SG in real-time are needed.
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Affiliation(s)
- Larry A. Fox
- Nemours Children’s Health System, Jacksonville, FL
| | | | - Kim Englert
- Nemours Children’s Health System, Jacksonville, FL
| | - Jobayer Hossain
- Biostatistics Core, Alfred I. duPont Hospital for Children, Wilmington, DE
| | - Nelly Mauras
- Nemours Children’s Health System, Jacksonville, FL
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Abstract
The glycemic goals of pregnancy are very narrow to reduce excess risks for numerous maternal and fetal complications. Continuous glucose monitors (CGMs) may help women achieve glucose goals and reduce hypoglycemia. CGM use has been found to be safe and effective in pregnancies associated with diabetes. CGM use can accurately identify glycemic patterns among women with and without diabetes in pregnancy. The data on the effects of CGM use on maternal and fetal outcomes are conflicting. Using CGMs in conjunction with continuous subcutaneous insulin infusion therapy in pregnancies complicated by diabetes may improve outcomes. There are limitations of CGM use that affect patients in and outside of pregnancy, as well as specific barriers that only affect pregnant women. Of importance, CGM use does not replace standard clinical care, but may be used an adjunctive tool in pregnancy. CGM remote monitoring in pregnancy is an understudied field. In this study, we review the studies on CGM use in pregnancy.
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Affiliation(s)
- Sarit Polsky
- Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado
| | - Rachel Garcetti
- Barbara Davis Center for Diabetes, University of Colorado Denver , Aurora, Colorado
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Abstract
Real-time continuous glucose monitoring has been available for a decade and reimbursement for the technology has been slowly growing. Reasons for the various rates of reimbursement and adoption are explored in this article and the status of country-wide reimbursement is discussed.
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Parkin CG, Graham C, Smolskis J. Continuous Glucose Monitoring Use in Type 1 Diabetes: Longitudinal Analysis Demonstrates Meaningful Improvements in HbA1c and Reductions in Health Care Utilization. J Diabetes Sci Technol 2017; 11:522-528. [PMID: 28745091 PMCID: PMC5505435 DOI: 10.1177/1932296817693253] [Citation(s) in RCA: 36] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Abstract
BACKGROUND Real-time continuous glucose monitoring (rtCGM) improves glycemic control in type 1 diabetes (T1D) patients treated with continuous subcutaneous insulin infusion (CSII). However, the benefits of rtCGM in T1D patients treated with multiple daily insulin injection (MDI) therapy has not been well studied. We explored the effects of rtCGM versus self-monitoring of blood glucose (SMBG) on clinical outcomes within a large T1D population treated with either CSII or MDI therapy. METHODS This retrospective, longitudinal analysis utilized datasets from T1D patients enrolled in a commercial health plan to assess changes in HbA1c in 187 naïve to rtCGM users and 6260 SMBG users. Propensity score modeling was used to assess inpatient admissions, emergency room (ER) visits in 1130 patients (565 rtCGM, 565 SMBG). Differences in HbA1c reduction (rtCGM+MDI vs rtCGM+CSII) were evaluated. RESULTS Larger, clinically meaningful HbA1c reductions were seen among rtCGM versus SMBG users: -0.5% ( P = .004) versus -0.2% ( P < .0001); 0.3% diff in diff, P = .03. All-cause inpatient admissions were lower for rtCGM users: -42%, P = .013. Emergency room visits coded for diabetic ketoacidosis (DKA) were four times higher for SMBG patients than rtCGM patients: 17 versus 4, P = .0318. HbA1c reductions were most notable with rtCGM+MDI versus rtCGM+CSII treatment: -0.6% ( P = .01) versus -0.3% ( P = .16). CONCLUSIONS Use of rtCGM in T1D patients facilitates greater HbA1c improvements and reduced health care system utilization compared with traditional SMBG use regardless of insulin administration method. Treatment with rtCGM in conjunction with MDI confers similar or greater glycemic benefits without the additional costs associated with CSII therapy.
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Affiliation(s)
- Christopher G. Parkin
- CGParkin Communications, Inc, Boulder City, NV, USA
- Christopher G. Parkin, MS, CGParkin Communications, Inc, 932 Vista Lago Way, Boulder City, NV 89005 USA.
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