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Straton E, Bryant BL, Kang L, Wang C, Barber J, Perkins A, Gallant L, Marks B, Agarwal S, Majidi S, Monaghan M, Streisand R. ROUTE-T1D: A behavioral intervention to promote optimal continuous glucose monitor use among racially minoritized youth with type 1 diabetes: Design and development. Contemp Clin Trials 2024; 140:107493. [PMID: 38460913 PMCID: PMC11065587 DOI: 10.1016/j.cct.2024.107493] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/27/2023] [Revised: 02/13/2024] [Accepted: 03/05/2024] [Indexed: 03/11/2024]
Abstract
BACKGROUND Type 1 diabetes management is often challenging during adolescence, and many youth with type 1 diabetes struggle with sustained and optimal continuous glucose monitor (CGM) use. Due to racial oppression and racially discriminatory policies leading to inequitable access to quality healthcare and life necessities, racially minoritized youth are significantly less likely to use CGM. METHODS ROUTE-T1D: Research on Optimizing the Use of Technology with Education is a pilot behavioral intervention designed to promote optimal CGM use among racially minoritized youth with type 1 diabetes. Intervention strategies include problem solving CGM challenges and promoting positive caregiver-youth communication related to CGM data. RESULTS This randomized waitlist intervention provides participants with access to three telemedicine sessions with a Certified Diabetes Care and Education Specialist. Caregiver participants are also connected with a peer-parent coach. CONCLUSION Hypothesized findings and anticipated challenges are discussed. Future directions regarding sustaining and optimizing the use of diabetes technology among racially minoritized pediatric populations are reviewed.
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Affiliation(s)
- Emma Straton
- Children's National Hospital, Washington DC, United States of America
| | - Breana L Bryant
- Children's National Hospital, Washington DC, United States of America
| | - Leyi Kang
- Children's National Hospital, Washington DC, United States of America
| | - Christine Wang
- Children's National Hospital, Washington DC, United States of America
| | - John Barber
- Children's National Hospital, Washington DC, United States of America
| | - Amanda Perkins
- Children's National Hospital, Washington DC, United States of America
| | - Letitia Gallant
- Children's National Hospital, Washington DC, United States of America
| | - Brynn Marks
- Children's Hospital of Philadelphia, Philadelphia, PA, United States of America
| | - Shivani Agarwal
- Albert Einstein College of Medicine, Bronx, NY, United States of America
| | - Shideh Majidi
- Children's National Hospital, Washington DC, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America
| | - Maureen Monaghan
- National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD, United States of America
| | - Randi Streisand
- Children's National Hospital, Washington DC, United States of America; The George Washington University School of Medicine, Washington, DC, United States of America.
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Harrod JC, Cheung YMM, Buckley L, Cromwell GE, Fowler KM, Hughes ME, Lin NU, Tolaney SM, Min L, McDonnell ME. Impact of personalized diabetes care on distress and treatment satisfaction in people with breast cancer. Diabet Med 2024; 41:e15292. [PMID: 38291604 DOI: 10.1111/dme.15292] [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: 07/20/2023] [Revised: 01/12/2024] [Accepted: 01/17/2024] [Indexed: 02/01/2024]
Abstract
AIMS In patients with breast cancer (BCa) and diabetes (DM), diabetes distress (DD) and treatment satisfaction (DTS) can influence BCa management and outcomes. We assessed the impact of implementing a personalized diabetes care model in patients with BCa. METHODS Patients in active treatment or surveillance for BCa with an HbA1c > 53 mmol/mol (7%) or random blood glucose >11.1 mmol/L were included. Participants were offered continuous glucose monitoring (CGM), virtual care and a dedicated diabetes provider for 6 months. Primary outcomes included DD measured by the Diabetes Distress Survey (DDS) and DTS measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Questionnaires were conducted at 0, 3 and 6 months. RESULTS Thirty-one women were enrolled (median age 61, IQR 49.0-69.0). Compared to baseline, the mean DDS score was lower at both 3 months (2.2 vs. 1.8 [n = 27], p = 0.004, SD = 0.70) and 6 months (2.3 vs. 1.8 [n = 23], p = 0.002, SD = 0.70). The mean DTSQ score was higher at 3 months (baseline: 20.5 vs. 3 months: 28.7 [n = 28], p < 0.001, SD = 9.2) and 6 months (baseline: 20.4 vs. 6 months: 30.0 [n = 26], p < 0.001, SD = 9.7). CONCLUSIONS Personalized diabetes care models that emphasize remote management and optimize access for those with BCa may lower DD and improve DTS.
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Affiliation(s)
- Julia C Harrod
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Yee-Ming M Cheung
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
- Division of Endocrinology, Diabetes and Metabolism, Northwell Health, Manhasset, New York, USA
| | - Lauren Buckley
- Division of Breast Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
| | - Grace E Cromwell
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Kristen M Fowler
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Melissa E Hughes
- Division of Breast Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
| | - Nancy U Lin
- Division of Breast Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
| | - Sara M Tolaney
- Division of Breast Oncology, Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
| | - Le Min
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
| | - Marie E McDonnell
- Division of Endocrinology, Diabetes, and Hypertension, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA
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Garretson S, Parmar A, Streisand R, Jaser S, Datye K. Updating Our Understanding of Device Use in Adolescents: Demographic Factors and Preferences in a Group of Adolescents With Type 1 Diabetes. Sci Diabetes Self Manag Care 2024; 50:9-18. [PMID: 38240246 PMCID: PMC10851623 DOI: 10.1177/26350106231220023] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/08/2024]
Abstract
PURPOSE The purpose of the study was to identify demographic factors associated with continuous glucose monitor (CGM) and automated insulin delivery (AID) use among adolescents with type 1 diabetes and to explore why adolescents may start and stop using CGMs. METHODS Adolescents ages 13 to 17 and caregivers completed demographic and device use surveys at baseline for a randomized trial of a behavioral intervention conducted at 2 large medical centers in the United States. This study is a secondary analysis of the demographic and device use data. RESULTS The study sample consisted of 198 participants ages 13 to 17, 58% female, 57% non-Hispanic White, 24% non-Hispanic Black, 19% other race and ethnicity. Eighty-one percent of adolescents were using CGM, and 10% reported past use. Forty percent of adolescents reported taking CGM breaks ranging hours to weeks. Higher CGM use was found in higher income families (>$90 000). No difference in CGM use was observed related to race or ethnicity. CONCLUSIONS These findings suggest CGM use is increasing even among adolescents, a group that historically has had the lowest device use. However, adolescents often take CGM breaks, and it is not clear if they adjust their diabetes management during these times. It is important for providers to understand when and why patients may take CGM breaks so education about diabetes management while off CGM can occur. Further investigation into management during CGM breaks, particularly in those using an AID system, is needed.
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Affiliation(s)
| | - Angelee Parmar
- Vanderbilt University Medical Center, Nashville, Tennessee
| | - Randi Streisand
- The George Washington University School of Medicine, Washington, District of Columbia
- Children's National Hospital, Washington, District of Columbia
| | - Sarah Jaser
- Vanderbilt University Medical Center, Nashville, Tennessee
| | - Karishma Datye
- Vanderbilt University Medical Center, Nashville, Tennessee
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González-Pacheco H, Rivero-Santana A, Ramallo-Fariña Y, Valcárcel-Nazco C, Álvarez-Pérez Y, García-Pérez L, García-Bello MA, Perestelo-Pérez L, Serrano-Aguilar P. Effectiveness, safety and costs of the FreeStyle Libre glucose monitoring system for children and adolescents with type 1 diabetes in Spain: a prospective, uncontrolled, pre-post study. BMJ Open 2023; 13:e071334. [PMID: 38097245 PMCID: PMC10729222 DOI: 10.1136/bmjopen-2022-071334] [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: 01/26/2023] [Accepted: 11/09/2023] [Indexed: 12/18/2023] Open
Abstract
OBJECTIVES This study aimed to evaluate the effectiveness, safety and costs of FreeStyle Libre (FSL) glucose monitoring system for children and adolescents with type 1 diabetes mellitus (T1DM) in Spain. DESIGN Prospective, multicentre pre-post study. SETTING Thirteen Spanish public hospitals recruited patients from January 2019 to March 2020, with a 12-month follow-up. PARTICIPANTS 156 patients were included. PRIMARY AND SECONDARY OUTCOME MEASURES Primary: glycated haemoglobin (HbA1c) change. Secondary: severe hypoglycaemic events (self-reported and clinical records), quality of life, diabetes treatment knowledge, treatment satisfaction, adverse events, adherence, sensor usage time and scans. Healthcare resource utilisation was assessed for cost analysis from the National Health System perspective, incorporating direct healthcare costs. Data analysis used mixed regression models with repeated measures. The intervention's total cost was estimated by multiplying health resource usage with unit costs. RESULTS In the whole sample, HbA1c increased significantly (0.32%; 95% CI 0.10% to 0.55%). In the subgroup with baseline HbA1c≥7.5% (n=88), there was a significant reduction at 3 months (-0.46%; 95% CI -0.69% to -0.23%), 6 months (-0.49%; 95% CI -0.73% to -0.25%) and 12 months (-0.43%; 95% CI -0.68% to -0.19%). Well-controlled patients had a significant 12-month worsening (0.32%; 95% CI 0.18% to 0.47%). Self-reported severe hypoglycaemia significantly decreased compared with the previous year for the whole sample (-0.37; 95% CI -0.62 to -0.11). Quality of life and diabetes treatment knowledge showed no significant differences, but satisfaction increased. Adolescents had lower sensor usage time and scans than children. Reduction in HbA1c was significantly associated with device adherence. No serious adverse effects were observed. Data suggest that use of FSL could reduce healthcare resource use (strips and lancets) and costs related to productivity loss. CONCLUSIONS The use of FSL in young patients with T1DM was associated with a significant reduction in severe hypoglycaemia, and improved HbA1c levels were seen in patients with poor baseline control. Findings suggest cost savings and productivity gains for caregivers. Causal evidence is limited due to the study design. Further research is needed to confirm results and assess risks, especially for patients with lower baseline HbA1c.
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Affiliation(s)
- Himar González-Pacheco
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Amado Rivero-Santana
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Yolanda Ramallo-Fariña
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Cristina Valcárcel-Nazco
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Yolanda Álvarez-Pérez
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Lidia García-Pérez
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Miguel Angel García-Bello
- Canary Islands Health Research Institute Foundation (FIISC), Tenerife, Spain
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
| | - Lilisbeth Perestelo-Pérez
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
- Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain
| | - Pedro Serrano-Aguilar
- Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS), Tenerife, Spain
- Institute of Biomedical Technologies (ITB), Tenerife, Spain
- Network for Research on Chronicity, Primary Care, and Health Promotion (RICAPPS), Tenerife, Spain
- Evaluation Unit (SESCS), Canary Islands Health Services (SCS), Tenerife, Spain
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Weinstein JM, Berkowitz SA, Pratley RE, Shah KS, Kahkoska AR. Statistically Adjusting for Wear Time in Randomized Trials of Continuous Glucose Monitors as a Complement to Intent-to-Treat and As-Treated Analyses: Application and Evaluation in Two Trials. Diabetes Technol Ther 2023; 25:457-466. [PMID: 36999890 PMCID: PMC10398732 DOI: 10.1089/dia.2023.0029] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 04/01/2023]
Abstract
Background: Randomized trials of continuous glucose monitoring (CGM) often estimate treatment effects using standard intent-to-treat (ITT) analyses. We explored how adjusting for CGM-measured wear time could complement existing analyses by estimating the effect of receiving and using CGM 100% of the time. Methods: We analyzed data from two 6-month CGM trials spanning diverse ages, the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) and CGM Intervention in Teens and Young Adults with Type 1 Diabetes (CITY) Studies. To adjust the ITT estimates for CGM use, as measured by wear time, we used an instrumental variable (IV) approach with the treatment assignment as an instrument. Outcomes included (1) time in range ([TIR] 70-180 mg/dL), time below range ([TBR] ≤70 mg/dL), and time above range ([TAR] ≥250 mg/dL). We estimated outcomes based on CGM use in the last 28 days of the trial and the full trial. Findings: In the WISDM study, the wear time rates over the 28-day window and full trial period were 93.1% (standard deviation [SD]: 20.4) and 94.5% (SD: 11.9), respectively. In the CITY study, the wear time rates over the 28-day window and full trial period were 82.2% (SD: 26.5) and 83.1% (SD: 21.5), respectively. IV-based estimates for the effect of CGM on TIR, TBR, and TAR suggested greater improvements in glycemic management than the ITT counterparts. The magnitude of the differences was proportional to the level of wear time observed in the trials. Interpretation: In trials of CGM use, the effect of variable wear time is non-negligible. By providing adherence-adjusted estimates, the IV approach may have additional utility for individual clinical decision-making.
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Affiliation(s)
- Joshua M. Weinstein
- Department of Health Policy and Management, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Seth A. Berkowitz
- Division of General Medicine and Clinical Epidemiology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | | | - Kushal S. Shah
- Department of Biostatistics, and Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
| | - Anna R. Kahkoska
- Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Center for Aging and Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA
- Division of Endocrinology and Metabolism, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA
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6
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Pemberton JS, Wilmot EG, Barnard-Kelly K, Leelarathna L, Oliver N, Randell T, Taplin CE, Choudhary P, Adolfsson P. CGM accuracy: Contrasting CE marking with the governmental controls of the USA (FDA) and Australia (TGA): A narrative review. Diabetes Obes Metab 2023; 25:916-939. [PMID: 36585365 DOI: 10.1111/dom.14962] [Citation(s) in RCA: 10] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/05/2022] [Revised: 12/12/2022] [Accepted: 12/23/2022] [Indexed: 01/01/2023]
Abstract
The National Institute for Clinical Excellence updated guidance for continuous glucose monitoring (CGM) in 2022, recommending that CGM be available to all people living with type 1 diabetes. Manufacturers can trade in the UK with Conformité Européenne (CE) marking without an initial national assessment. The regulatory process for CGM CE marking, in contrast to the Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) process, is described. Manufacturers operating in the UK provided clinical accuracy studies submitted for CE marking. Critical appraisal of the studies shows several CGM devices have CE marking for wide-ranging indications beyond available data, unlike FDA and TGA approval. The FDA and TGA use tighter controls, requiring comprehensive product-specific clinical data evaluation. In 2018, the FDA published the integrated CGM (iCGM) criteria permitting interoperability. Applying the iCGM criteria to clinical data provided by manufacturers trading in the UK identified several study protocols that minimized glucose variability, thereby improving CGM accuracy on all metrics. These results do not translate into real-life performance. Furthermore, for many CGM devices available in the UK, accuracy reported in the hypoglycaemic range is below iCGM standards, or measurement is absent. We offer a framework to evaluate CGM accuracy studies critically. The review concludes that FDA- and TGA-approved indications match the available clinical data, whereas CE marking indications can have discrepancies. The UK can bolster regulation with UK Conformity Assessed marking from January 2025. However, balanced regulation is needed to ensure innovation and timely technological access are not hindered.
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Affiliation(s)
- John S Pemberton
- Department of Endocrinology and Diabetes, Birmingham Children's Hospital, Birmingham Women's, and Children's NHS Foundation Trust, Birmingham, UK
| | - Emma G Wilmot
- University Hospitals of Derby and Burton NHS Foundation Trust, Derby, UK
- University of Nottingham, Nottingham, UK
| | | | - Lalantha Leelarathna
- Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
- Division of Diabetes, Endocrinology and Gastroenterology, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK
| | - Nick Oliver
- Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK
| | | | - Craig E Taplin
- Department of Endocrinology and Diabetes, Perth Children's Hospital, Perth, Australia
- Telethon Kids Institute, University of Western Australia, Perth, Australia
- Centre for Child Health Research, University of Western Australia, Perth, Australia
| | - Pratik Choudhary
- Leicester Diabetes Center, University of Leicester, Leicester, UK
| | - Peter Adolfsson
- Department of Paediatrics, Kungsbacka Hospital; Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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Cameron FJ, Arnold M, Gregory JW. Adolescent ambivalence about diabetes technology-The Janus faces of automated care. Pediatr Diabetes 2022; 23:1717-1724. [PMID: 36183170 PMCID: PMC10091736 DOI: 10.1111/pedi.13423] [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: 08/25/2022] [Revised: 09/27/2022] [Accepted: 09/28/2022] [Indexed: 12/29/2022] Open
Abstract
The Janus face metaphor approach highlights that a technology may simultaneously have two opposite faces or properties with unforeseen paradoxes within human-technology interaction. Suboptimal acceptance and clinical outcomes are sometimes seen in adolescents who use diabetes-related technologies. A traditional linear techno-determinist model of technology use would ascribe these unintended outcomes to suboptimal technology, suboptimal patient behavior, or suboptimal outcome measures. This paradigm has demonstratively not been successful at universally improving clinical outcomes over the last two decades. Alternatively, the Janus face metaphor moves away from a linear techno-determinist model and focuses on the dynamic interaction of the human condition and technology. Specifically, it can be used to understand variance in adoption or successful use of diabetes-related technology and to retrospectively understand suboptimal outcomes. The Janus face metaphor also allows for a prospective exploration of potential impacts of diabetes-related technology by patients, families, and their doctors so as to anticipate and minimize potential subsequent tensions.
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Affiliation(s)
- Fergus J Cameron
- Department of Endocrinology and Diabetes, Murdoch Children's Research Institute, The Royal Children's Hospital, Melbourne, Australia.,Department of Paediatrics, The University of Melbourne, Melbourne, Australia
| | - Michael Arnold
- School of Historical and Philosophical Studies, The University of Melbourne, Melbourne, Australia
| | - John W Gregory
- Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK
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8
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Azri N, Norsa'adah B, Hassan NB, Naing NN. Insulin Adherence and Associated Factors in Patients with Type 2 Diabetes Mellitus Treated in Klang Primary Health Care Centres. Malays J Med Sci 2022; 28:76-87. [PMID: 35002492 PMCID: PMC8715880 DOI: 10.21315/mjms2021.28.6.8] [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: 02/22/2021] [Accepted: 06/10/2021] [Indexed: 11/05/2022] Open
Abstract
Background Insulin therapy is necessary for patients with type 2 diabetes mellitus (T2DM) to reach the targeted glycaemic level and prevent complications. This study aimed to determine the proportion of adherence to insulin therapy and the associated factors in patients with T2DM. Methods A cross-sectional study was conducted among 249 patients with T2DM who had been on insulin therapy for at least 2 months in primary care centres of the Ministry of Health in Klang, Malaysia. A validated insulin adherence questionnaire for diabetes mellitus (DM) was used to assess insulin adherence. Data on the sociodemographic characteristics, disease-related factors, treatment-related factors and clinical parameters were extracted from medical records and interviews with patients. Results The adherence to insulin therapy was 8.43%. The factors associated with insulin adherence were self-monitoring of blood glucose (SMBG) (adjusted odds ratio [AOR]: 5.39; 95% confidence interval (CI): 1.20, 24.13; P = 0.028), exercise (AOR: 3.38; 95% CI: 1.37, 10.03; P = 0.029) and the number of daily insulin injections (AOR: 1.63; 95% CI: 1.09, 2.44; P = 0.017). Conclusion The adherence to insulin therapy in primary health care centres in Malaysia was very poor. Patients who practiced SMBG, exercised and frequent daily insulin injections were significantly more adherent to insulin therapy.
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Affiliation(s)
- Nasruddin Azri
- Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.,National Pharmaceutical Regulatory Division, Ministry of Health Malaysia, Petaling Jaya, Selangor, Malaysia
| | - Bachok Norsa'adah
- Unit of Biostatistics and Research Methodology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
| | - Norul Badriah Hassan
- Department of Pharmacology, School of Medical Sciences, Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia
| | - Nyi Nyi Naing
- Faculty of Medicine, Universiti Sultan Zainal Abidin, Medical Campus, Kuala Terengganu, Terengganu, Malaysia
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Blissett DB, Attvall S, Hellmund RA. Analysis Estimating the Potential Cost Impact of Utilizing Flash Glucose Monitoring with Optional Alarms in Swedish Adults with Diabetes with Impaired Awareness of Hypoglycaemia, Using Intensive Insulin. Diabetes Ther 2021; 12:2179-2193. [PMID: 34232483 PMCID: PMC8342735 DOI: 10.1007/s13300-021-01099-7] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/26/2020] [Accepted: 06/10/2021] [Indexed: 11/26/2022] Open
Abstract
INTRODUCTION The objective of this analysis was to estimate the costs associated with using flash glucose monitoring with optional alarms as a replacement for either traditional continuous glucose monitoring (CGM) or routine self-monitoring of blood glucose (SMBG) in adults with diabetes and impaired awareness of hypoglycaemia (IAH) who use intensified insulin therapy, from a Swedish payer perspective, applying assumptions to simulate hypothetical scenarios. METHODS A simple two-state cohort Markov model was used to calculate the cost per patient treated over a 3-year period, capturing the risk of severe hypoglycaemic events requiring medical assistance and non-adherence using quarterly Markov cycles. The costs considered were those for glucose monitoring and resource use to treat severe hypoglycaemic events. Cost inputs were sourced from Swedish price lists, manufacturer data and resource use reported in the control arm of the HypoDE study. Targeted literature searches were run in PubMed to source the clinical inputs. Uncertainty in the model was considered through one-way sensitivity analysis and scenario analysis. RESULTS Over 3 years, flash monitoring with optional alarms resulted in potential cost-savings of Swedish krona (SEK) 7708 and SEK 69,908 per patient when compared to routine SMBG or CGM respectively. Sensitivity and scenario analyses were largely supportive of this conclusion with respect to SMBG, and large cost-savings were consistent across all sensitivity and scenario analyses with respect to CGM. CONCLUSION Utilizing flash monitoring with optional alarms is potentially a cost-saving treatment strategy compared to routine SMBG or traditional CGM in adults with diabetes using intensive insulin and IAH from a Swedish payer perspective. Future studies in the IAH population will help to assess more precisely the relative cost impact of flash glucose monitoring with optional alarms compared with SMBG and traditional CGM.
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Affiliation(s)
| | - Stig Attvall
- Diabetes, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden
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10
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Datye KA, Tilden DR, Parmar AM, Goethals ER, Jaser SS. Advances, Challenges, and Cost Associated with Continuous Glucose Monitor Use in Adolescents and Young Adults with Type 1 Diabetes. Curr Diab Rep 2021; 21:22. [PMID: 33991264 PMCID: PMC8575075 DOI: 10.1007/s11892-021-01389-1] [Citation(s) in RCA: 9] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 04/27/2021] [Indexed: 02/06/2023]
Abstract
PURPOSE OF REVIEW Continuous glucose monitors (CGM) are transforming diabetes management, yet adolescents and young adults (AYA) with type 1 diabetes (T1D) do not experience the same benefits seen with CGM use in adults. The purpose of this review is to explore advances, challenges, and the financial impact of CGM use in AYA with T1D. RECENT FINDINGS CGM studies in young adults highlight challenges and suggest unique barriers to CGM use in this population. Recent studies also demonstrate differences in CGM use related to race and ethnicity, raising questions about potential bias and emphasizing the importance of patient-provider communication. Cost of these devices remains a significant barrier, especially in countries without nationalized reimbursement of CGM. More research is needed to understand and address the differences in CGM utilization and to increase the accessibility of CGM therapy given the significant potential benefits of CGM in this high-risk group.
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Affiliation(s)
- Karishma A Datye
- Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Vanderbilt University Medical Center, 1500 21st Ave. South Suite 1514, Nashville, TN, 37212-3157, USA.
| | - Daniel R Tilden
- Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Vanderbilt University Medical Center, 1500 21st Ave. South Suite 1514, Nashville, TN, 37212-3157, USA
- Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA
| | - Angelee M Parmar
- Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Vanderbilt University Medical Center, 1500 21st Ave. South Suite 1514, Nashville, TN, 37212-3157, USA
| | - Eveline R Goethals
- Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Vanderbilt University Medical Center, 1500 21st Ave. South Suite 1514, Nashville, TN, 37212-3157, USA
| | - Sarah S Jaser
- Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Department of Pediatrics, Vanderbilt University Medical Center, 1500 21st Ave. South Suite 1514, Nashville, TN, 37212-3157, USA
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11
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Ziegler R, Heinemann L, Freckmann G, Schnell O, Hinzmann R, Kulzer B. Intermittent Use of Continuous Glucose Monitoring: Expanding the Clinical Value of CGM. J Diabetes Sci Technol 2021; 15:684-694. [PMID: 32064909 PMCID: PMC8120049 DOI: 10.1177/1932296820905577] [Citation(s) in RCA: 13] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/11/2022]
Abstract
In addition to the continuous use, the intermittent use of continuous glucose monitoring (CGM) is an application of CGM, expanding the typical medical use cases. There are a variety of reasons and occasions that speak in favor of using CGM only for a limited time. To date, these circumstances have not been sufficiently discussed. In this article, we define discontinuous or intermittent CGM use, provide reasons for using it, and expand on the benefits and possibilities of using CGM on a temporary basis. We aim to draw attention to this important topic in the discussion of CGM use and give examples for a different method of CGM use. As well, we would like to foster the allocation of CGM to the right patient groups and indications, especially in cases of limited resources. From a global point of view, intermittent CGM use is more likely to occur than continuous use, primarily for economic reasons.
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Affiliation(s)
- Ralph Ziegler
- Diabetes Clinic for Children and
Adolescents, Muenster, Germany
- Ralph Ziegler, MD, Diabetes Clinic
for Children and Adolescents Mondstr. 148, Muenster 48155, Germany.
| | | | - Guido Freckmann
- Institut für Diabetes-Technologie,
Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm,
Germany
| | - Oliver Schnell
- Forschergruppe Diabetes e.V.,
Helmholtz Zentrum, Munich, Germany
| | | | - Bernd Kulzer
- Diabetes Center Bad Mergentheim,
Research Institute of the Diabetes Academy, Bad Mergentheim, University
Bamberg, Germany
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12
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Lou G, Larramona G, Montaner T, Barbed S. Effect of CGM in the HbA1c and Coefficient of Variation of glucose in a pediatric sample. Prim Care Diabetes 2021; 15:289-292. [PMID: 33132064 DOI: 10.1016/j.pcd.2020.10.005] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/29/2020] [Revised: 10/08/2020] [Accepted: 10/10/2020] [Indexed: 11/22/2022]
Abstract
AIM OF THE STUDY Previous studies have found no significant improvements in glycated hemoglobin (HbA1c), while using Continuous Glucose Monitoring (CGM), with children and adolescents. The aim of this paper is to measure the change in HbA1c, and the Coefficient of Variation in glucose levels, when using CGM, once the effect of other relevant variables, such as gender, actual age, the years the patient has had diabetes, use of an insulin pump, the presence of autoimmune disease, other associated pathologies, and weekly hours of exercise, are controlled for. METHODS This is a retrospective study that uses a linear regression model. Data was collected from Type 1 Diabetes Mellitus (T1DM), children diagnosed between 2003 and 2017 in the Pediatric Unit for Diabetes in Zaragoza, Spain. We used a linear regression and the method of estimation is Ordinary Least Squares. RESULTS Results show that the use of CGM decreased the HbA1c value by 3.5% and the Coefficient of Variation by 14%. CONCLUSIONS The implication of these results is that this device helped in the management of diabetes, although more research is needed to distinguish between different devices in terms of their efficacy.
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Affiliation(s)
- Graciela Lou
- Unidad de Diabetes Pediatrica, Hospital Infantil Miguel Servet, Paseo Isabel la Católica, 1-3, 5009 Zaragoza, Spain; Centro de Salud de Binéfar, Calle Mariano de Pano, 34, 22500 Binéfar, Spain.
| | - Gemma Larramona
- Facultad de Economía y Empresa, Universidad de Zaragoza, Gran Vía, 2, 50005 Zaragoza, Spain.
| | - Teresa Montaner
- Facultad de Economía y Empresa, Universidad de Zaragoza, María de Luna, 50018 Zaragoza, Spain.
| | - Sara Barbed
- Unidad de Diabetes Pediatrica, Hospital Infantil Miguel Servet, Paseo Isabel la Católica, 1-3, 5009 Zaragoza, Spain; Centro de Salud de Ejea de los Caballeros, Paseo de la Constitución, 50600 Ejea de los Caballeros, Zaragoza, Spain.
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13
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Lind N, Lindqvist Hansen D, Sætre Rasmussen S, Nørgaard K. Real-time continuous glucose monitoring versus self-monitoring of blood glucose in adults with insulin-treated type 2 diabetes: a protocol for a randomised controlled single-centre trial. BMJ Open 2021; 11:e040648. [PMID: 33452188 PMCID: PMC7813336 DOI: 10.1136/bmjopen-2020-040648] [Citation(s) in RCA: 4] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022] Open
Abstract
INTRODUCTION Medical treatment options for type 2 diabetes (T2D) have increased over the last decade and enhance the possibility of individualised treatment strategies where insulin is still one of them. In spite of the advancements in treatment options, less than one-third of the population with T2D obtain their optimal glycaemic goal. In persons with type 1 diabetes, continuous glucose monitoring (CGM) has shown to be the most important driver for improvement in glycaemic control, even more than insulin-pump therapy. The use of technology in T2D has only been investigated in few studies.The overall objective of the research study is to examine the effectiveness of the use of CGM versus self-monitoring of blood glucose (SMBG) in persons with insulin-treated T2D on glycaemic variables and patient-reported outcomes on treatment satisfaction, health behaviour and well-being. The independent effect of peer support will also be studied. METHODS AND ANALYSIS The study is a single centre, prospective, randomised, open-labelled, three-armed study with the randomisation 2:1:2 in group A with CGM, group B with CGM and peer support, and group C as a control group with SMBG. The participants receive a training course unique for the allocation group. The study runs for 12 months and includes 100 adult participants with insulin-treated T2D, treated at the outpatient clinic at Steno Diabetes Center Copenhagen. Primary outcome is difference in change in time in range. Recruitment begins in August 2020 and ends in July 2021. Final 12-month follow-up is anticipated to be in August 2022. ETHICS AND DISSEMINATION The study will be carried out in accordance with the Helsinki Declaration and is approved by the Scientific Ethics Committee of the Capital Region (H-20000843). Data collection and handling will be performed in accordance with the General Data Protection Regulation and is approved by the Danish Data Protection Agency (J-2020-100). Dissemination will be in international peer-reviewed journals, conferences and a plain-language summary for participants. TRIAL REGISTRATION NUMBER ClinicalTrials.gov Registry (NCT04331444). PROTOCOL VERSION V.3, 11 December 2020.
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Affiliation(s)
- Nanna Lind
- Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark
| | | | | | - Kirsten Nørgaard
- Clinical Research, Steno Diabetes Center Copenhagen, Gentofte, Denmark
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14
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Dovc K, Battelino T. Time in range centered diabetes care. Clin Pediatr Endocrinol 2021; 30:1-10. [PMID: 33446946 PMCID: PMC7783127 DOI: 10.1297/cpe.30.1] [Citation(s) in RCA: 27] [Impact Index Per Article: 6.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/15/2020] [Accepted: 09/17/2020] [Indexed: 12/11/2022] Open
Abstract
Optimal glycemic control remains challenging and elusive for many people with diabetes. With the comprehensive clinical evidence on safety and efficiency in large populations, and with broader reimbursement, the adoption of continuous glucose monitoring (CGM) is rapidly increasing. Standardized visual reporting and interpretation of CGM data and clear and understandable clinical targets will help professionals and individuals with diabetes use diabetes technology more efficiently, and finally improve long-term outcomes with less everyday disease burden. For the majority of people with type 1 or type 2 diabetes, time in range (between 70 and 180 mg/dL, or 3.9 and 10 mmol/L) target of more than 70% is recommended, with each incremental increase of 5% towards this target being clinically meaningful. At the same time, the goal is to minimize glycemic excursions: a recommended target for a time below range (< 70 mg/dL or < 3.9 mmol/L) is less than 4%, and time above range (> 180 mg/dL or 10 mmol/L) less than 25%, with less stringent goals for older individuals or those at increased risk. These targets should be individualized: the personal use of CGM with the standardized data presentation provides all necessary means to accurately tailor diabetes management to the needs of each individual with diabetes.
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Affiliation(s)
- Klemen Dovc
- University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Tadej Battelino
- University Children's Hospital, University Medical Center Ljubljana, Ljubljana, Slovenia
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
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15
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Swaney EE, McCombe J, Coggan B, Donath S, O'Connell MA, Cameron FJ. Has subsidized continuous glucose monitoring improved outcomes in pediatric diabetes? Pediatr Diabetes 2020; 21:1292-1300. [PMID: 32829528 DOI: 10.1111/pedi.13106] [Citation(s) in RCA: 8] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/15/2020] [Revised: 08/13/2020] [Accepted: 08/17/2020] [Indexed: 12/27/2022] Open
Abstract
INTRODUCTION In 2017, the Australian Federal Government fully subsidized continuous glucose monitoring (CGM) devices for patients under 21 years of age with T1D with the aim of reducing rates of severe hypoglycaemia (SH) and improving metabolic control. The aim of this study was to reports on metabolic outcomes in youth from a single tertiary centre. METHODS The study design was observational. Data were obtained on youth who commenced CGM between May 2017 and December 2019. RESULTS Three hundred and forty one youth who commenced CGM and had clinical outcome data for a minimum of 4 months. 301, 261, 216, 172, and 125 had outcome data out to 8, 12, 16, 20, and 24 months, respectively. Cessation occurred between 27.9% and 32.8% of patients 12 to 24 months after CGM commencement. HbA1c did not change in patients who continued to use CGM. In the 12 months prior to starting CGM the rate of severe hypoglycaemia events were 5.0 per 100 patient years. The rates of severe hypoglycaemia in those continuing to use CGM at 4, 8, 12, 16, 20, and 24 months, were 5.2, 5.1, 1.6, 6.1, 2.4, and 0 per 100 patient years, respectively. DISCUSSION Our experience of patients either ceasing or underusing CGM is less than reported in other cohorts but is nonetheless still high. There may have been a reduction in rates of severe hypoglycaemia over the 24 months follow up period; however, the absolute numbers of events were so low as to preclude meaningful statistical analysis.
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Affiliation(s)
- Ella Ek Swaney
- Diabetes Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia
| | - Julia McCombe
- Diabetes Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.,The Department of Endocrinology and Diabetes, Royal Children's Hospital, Parkville, Victoria, Australia
| | - Brenda Coggan
- The Department of Endocrinology and Diabetes, Royal Children's Hospital, Parkville, Victoria, Australia
| | - Susan Donath
- Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Parkville, Victoria, Australia
| | - Michele A O'Connell
- Diabetes Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.,The Department of Endocrinology and Diabetes, Royal Children's Hospital, Parkville, Victoria, Australia
| | - Fergus J Cameron
- Diabetes Research, Murdoch Children's Research Institute, Parkville, Victoria, Australia.,The Department of Endocrinology and Diabetes, Royal Children's Hospital, Parkville, Victoria, Australia.,The Department of Paediatrics, University of Melbourne, Parkville, Victoria, Australia
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16
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Abstract
Optimal glycemic control remains challenging in individuals with type 1 diabetes. With the comprehensive clinical evidence on safety and efficiency, the adoption of continuous glucose monitoring (CGM), insulin pumps, and control algorithms merging the two into closed-loop systems is rapidly increasing. Particularly the CGM and intermittently scanned CGM improved diabetes management outcomes in large populations. A meaningful translation from clinical trials in highly controlled settings to numerous evaluations of closed-loop technology in the unrestricted home environment ended with its commercialization and use in routine clinical practice. Although it is still not a cure, the closed-loop currently seems to be the most promising advancement in the treatment of diabetes, with promising results also reported from routine clinical practice in children and adults with type 1 diabetes. We summarize different aspects of a technological approach to diabetes care, list currently available devices and systems in the pipeline, and the key supporting clinical evidence for their use. We consider human factors associated with technology use and the importance of health economics to support implementation and reimbursement.
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Affiliation(s)
- Klemen Dovc
- Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, Ljubljana, Slovenia.,Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Tadej Battelino
- Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, Ljubljana, Slovenia - .,Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
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17
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Farfel A, Liberman A, Yackobovitch-Gavan M, Phillip M, Nimri R. Executive Functions and Adherence to Continuous Glucose Monitoring in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther 2020; 22:265-270. [PMID: 31789577 DOI: 10.1089/dia.2019.0341] [Citation(s) in RCA: 5] [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: 01/17/2023]
Abstract
Background: Continuous glucose monitoring (CGM) has a beneficial impact on diabetes control; however, its utilization within people with diabetes remains low. The success of CGM requires cluster of cognitive skills and executive functions (EF). We speculated that participants with high EF would be more adherent to CGM use. Materials and Methods: The study population included 85 children and adolescents between 5 and 18 years old being followed for type 1 diabetes. Participants and their parents completed three questionnaires-"Behavior Rating Inventory of Executive Function" (BRIEF), CGM satisfaction, and a questionnaire assessing reasons for discontinuing CGM use. Results: Sixty-one participants used CGM on a regular basis and 24 discontinued use. Adherent participants were significantly younger than participants with nonadherence to CGM (P = 0.011). No significant differences were found between gender, diabetes duration, or HbA1c. Females adhering to CGM had a significantly higher "organization of environment" skill than those with nonadherence to CGM (P = 0.023). Also, adherent participants older than 14 years had a higher "organization of environment" skill than participants with nonadherence to CGM (P = 0.032). No difference was found between the groups in other EF domains. Alarm fatigue was found to be the main reason for discontinuing CGM. Conclusions: Given the interplay between CGM adherence and EF, it is recommended that people with diabetes should receive training by a multidisciplinary team, including psychological counseling, before CGM use and thus preparing them to cope with the demands of CGM and to avoid false expectations.
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Affiliation(s)
- Alon Farfel
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
- Department of Pediatrics Assuta, Ashdod University Hospital, Ashdod, Israel
- Faculty of Health Sciences, Ben Gurion University, Beer Sheva, Israel
| | - Alon Liberman
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
- Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Michal Yackobovitch-Gavan
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
| | - Moshe Phillip
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
- Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Revital Nimri
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel, Petah Tikva, Israel
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18
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Abstract
Technological innovations have fundamentally changed diabetes care. Insulin pump use and continuous glucose monitoring are associated with improved glycemic control along with a better quality of life; automated insulin-dosing advisors facilitate and improve decision making. Glucose-responsive automated insulin delivery enables the highest targets for time in range, lowest rate and duration of hypoglycemia, and favorable quality of life. Clear targets for time in ranges and a standard visualization of the data will help the diabetes technology to be used more efficiently. Decision support systems within and integrated cloud environment will further simplify, unify, and improve modern routine diabetes care.
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Affiliation(s)
- Klemen Dovc
- Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, University Medical Centre Ljubljana, Bohoriceva 20, Ljubljana SI-1000, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Tadej Battelino
- Department of Paediatric Endocrinology, Diabetes and Metabolic Diseases, UMC - University Children's Hospital, University Medical Centre Ljubljana, Bohoriceva 20, Ljubljana SI-1000, Slovenia; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia.
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19
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Guzmán G, Martínez V, Yara JD, Mina MA, Solarte JS, Victoria AM, Fériz K. Glycemic Control and Hypoglycemia in Patients Treated with Insulin Pump Therapy: An Observational Study. J Diabetes Res 2020; 2020:1581726. [PMID: 32832557 PMCID: PMC7426788 DOI: 10.1155/2020/1581726] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/27/2019] [Revised: 06/24/2020] [Accepted: 07/11/2020] [Indexed: 11/25/2022] Open
Abstract
INTRODUCTION Diabetes mellitus (DM) is a highly prevalent disease worldwide. It has been associated with an important morbimortality due to its complications and sometimes as a result of adverse events related to treatment. Insulin pump therapy (IPT) is one of the options used to control this disease and reduces one of the most frequent complication associated with treatment: hypoglycemia, which has also a great impact on life quality and clinical status of patients. MATERIALS AND METHODS A descriptive and retrospective study was performed including patients treated and followed by the department of endocrinology from a high-complexity university hospital in Cali, Colombia, between 2012 and 2017. Patients were on IPT and continuous glucose monitoring (CGM): MiniMed Paradigm® Veo™ Insulin Pump (Medtronic®) and MiniMed 640G Insulin Pump-Enlite™ Sensor (Medtronic®). Presentation of hypoglycemia and variables associated with its development were evaluated. RESULTS 51 patients were included. The main indication for IPT initiation was the report of hypoglycemic episodes and inappropriate metabolic control. Initiation of IPT was related with a decrease in glycosylated hemoglobin (HbA1c) and also a decrease in severe hypoglycemic events and hospitalization due to hypoglycemia. The risk factors linked with clinically significant hypoglycemia were male gender, and standard deviation of glucose measures calculated by CGM. A diminished glomerular filtration rate (GFR) (<60 mL/min/1.73 m2) was correlated with higher risk of severe hypoglycemia. CONCLUSION IPT with CGM is a useful strategy in the management of patients with DM; it is associated with a reduction of adverse hypoglycemic events and hospitalizations due to hypoglycemia.
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Affiliation(s)
- Guillermo Guzmán
- Fundación Valle del Lili, Departamento de Endocrinología, Cra 98 No. 18-49, Cali 760032, Colombia
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
| | - Veline Martínez
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
- Fundación Valle del Lili, Departamento de Medicina Interna, Cra 98 No. 18-49, Cali 760032, Colombia
| | - Julián David Yara
- Fundación Valle del Lili, Departamento de Medicina Interna, Cra 98 No. 18-49, Cali 760032, Colombia
| | - Miguel Angel Mina
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
| | - Juan Sebastian Solarte
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
| | - Angela María Victoria
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
| | - Karen Fériz
- Fundación Valle del Lili, Departamento de Endocrinología, Cra 98 No. 18-49, Cali 760032, Colombia
- Universidad Icesi, Facultad de Ciencias de la Salud, Calle 18 No. 122-135, Cali, Colombia
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20
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Eleftheriadou I, Didangelos T, Pappas AC, Anastasiou E, Vasilopoulos C, Zoupas C, Manes C, Tsatsoulis A, Benroubi M, Pangalos E, Thomakos P, Gerasimidi-Vazeou A, Tentolouris N. Improvement of metabolic control after 3-month use of real-time continuous glucose monitoring in patients with type 1 diabetes: a multicenter study in Greece. Hormones (Athens) 2019; 18:443-450. [PMID: 31721132 DOI: 10.1007/s42000-019-00153-1] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/23/2019] [Accepted: 10/24/2019] [Indexed: 10/25/2022]
Abstract
PURPOSE To assess the efficacy of a real-time continuous glucose monitoring (RT-CGM) system added to insulin pump therapy for 3 months, in sub-optimally controlled adults with type 1 diabetes mellitus (T1D). METHODS This was a prospective, multicenter, non-randomized, post-market release study. A total of 43 adult patients with T1D on insulin pump therapy and inadequate glycemic control (HbA1c > 7.0%) participated in the study. The primary endpoint was the change from baseline HbA1c levels. Secondary objectives were to evaluate the impact of the RT-CGM system on glucose variability, daily insulin requirements, and the frequency of hypoglycemic and ketoacidosis events. RESULTS At 3 months, the baseline HbA1c values decreased from 8.0 (7.6, 8.7) to 7.1 (6.7, 8.0) % (p < 0.001). Nineteen participants (44.2%) had a posttreatment HbA1c level ≤ 7%. Average total daily insulin requirements, as well as the average number of insulin boluses per day, increased significantly after the use of the RT-CGM system. The number of hypoglycemic events recorded did not differ between the first week and last week of RT-CGM usage, while no severe hypoglycemic episodes, ketoacidosis events, or hospitalizations related to diabetes occurred during the 3-month follow-up period. CONCLUSION Addition of a RT-CGM system to insulin pump therapy for 3 months in inadequately controlled patients with T1D resulted in improved HbA1c levels, without increasing the risk of hypoglycemic events.
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Affiliation(s)
- Ioanna Eleftheriadou
- Diabetes Center, First Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece
| | - Triantafyllos Didangelos
- Diabetes Center, First Department of Internal Medicine, Medical School, AHEPA Hospital, Aristotle University, Thessaloniki, Greece
| | | | - Eleni Anastasiou
- Endocrinology Clinic, Alexandra General Hospital, Athens, Greece
| | | | | | - Christos Manes
- Second Department of Internal Medicine, Papageorgiou General Hospital, Thessaloniki, Greece
| | | | | | | | | | | | - Nikolaos Tentolouris
- Diabetes Center, First Department of Propaedeutic Internal Medicine, Medical School, Laiko General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
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21
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Onisie O, Crocket H, de Bock M. The CGM grey market: a reflection of global access inequity. Lancet Diabetes Endocrinol 2019; 7:823-825. [PMID: 31427219 DOI: 10.1016/s2213-8587(19)30263-3] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 05/27/2019] [Revised: 07/28/2019] [Accepted: 07/29/2019] [Indexed: 12/27/2022]
Affiliation(s)
- Oana Onisie
- Department of Paediatrics, University of Otago, Christchurch 8140, New Zealand
| | - Hamish Crocket
- School of Health, Sport & Human Performance, University of Waikato, Hamilton, New Zealand
| | - Martin de Bock
- Department of Paediatrics, University of Otago, Christchurch 8140, New Zealand; Department of Paediatrics, Canterbury District Health Board, Christchurch, New Zealand.
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22
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Smith MB, Albanese-O'Neill A, Macieira TGR, Yao Y, Abbatematteo JM, Lyon D, Wilkie DJ, Haller MJ, Keenan GM. Human Factors Associated with Continuous Glucose Monitor Use in Patients with Diabetes: A Systematic Review. Diabetes Technol Ther 2019; 21:589-601. [PMID: 31335196 DOI: 10.1089/dia.2019.0136] [Citation(s) in RCA: 20] [Impact Index Per Article: 3.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/23/2022]
Abstract
Consistent continuous glucose monitor (CGM) use is associated with substantial improvements in glycemic control, yet the uptake and continued use of these technologies remains low. This systematic review aims to identify and summarize the state of science on human factors and their association with CGM use to inform training methods and best practices that support adherence to CGM use and automated insulin delivery systems. A literature search was conducted in PubMed, CINAHL, The Cochrane Library, and PsychInfo databases using PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines to identify studies that reported psychological human factors related to CGM or sensor-augmented pump use in patients with type 1 diabetes. In total, 389 records were identified through our database search and 26 studies published between 2010 and 2017 were included. Articles underwent quality appraisal using the Effective Public Health Practice Project Quality Assessment Tool and were categorized according to study outcomes. Identified human factors with a potential association with CGM use were treatment satisfaction, quality of life, emotional distress, and self-efficacy. Eight patient-reported barriers to CGM use were identified as a subcomponent of satisfaction. To date, studies of human factors associated with CGM use generally lack standardized measures and sufficient methodological rigor necessary to establish causation. A more robust understanding of how identified human factors influence CGM use is necessary. Future studies should test interventions that target human factors to improve consistency of use and establish best practices for enhancing patients' experience and acceptance of these technologies, especially within adolescents and young adults.
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Affiliation(s)
- Madison B Smith
- PhD Program, College of Nursing, University of Florida, Gainesville, Florida
| | | | - Tamara G R Macieira
- PhD Program, College of Nursing, University of Florida, Gainesville, Florida
| | - Yingwei Yao
- Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida
| | | | - Debra Lyon
- Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida
| | - Diana J Wilkie
- Department of Biobehavioral Nursing Science, College of Nursing, University of Florida, Gainesville, Florida
| | - Michael J Haller
- Division of Pediatric Endocrinology, College of Medicine, University of Florida, Gainesville, Florida
| | - Gail M Keenan
- Department of Family, Community, and Health System Science, College of Nursing, University of Florida, Gainesville, Florida
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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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Choudhary P, de Portu S, Arrieta A, Castañeda J, Campbell FM. Use of sensor-integrated pump therapy to reduce hypoglycaemia in people with Type 1 diabetes: a real-world study in the UK. Diabet Med 2019; 36:1100-1108. [PMID: 31134668 DOI: 10.1111/dme.14043] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 05/25/2019] [Indexed: 01/04/2023]
Abstract
AIMS To assess the efficacy of insulin pumps with automated insulin suspension systems in a real-world setting. METHODS We analysed anonymized data uploaded to CareLink™ by people (n=920) with Type 1 diabetes using the MiniMed Paradigm Veo system and the MiniMed 640G system (Medtronic International Trading Sàrl, Tolochanez, Switzerland) with SmartGuard technology, with or without automated insulin suspension enabled, between February 2016 and June 2018. Users with ≥15 days of sensor data and ≥70% sensor-wear time were classified as sensor-augmented pump alone, sensor-integrated pump with low glucose suspend enabled or sensor-integrated pump with predictive low glucose management enabled. RESULTS The median (25th -75th percentile) system use was 161 (58-348) days. The median time spent with sensor glucose values ≤3 mmol/l was 0.8 (0.3-1.7)% in the sensor-augmented pump group, 0.3 (0.1-0.7)% in the sensor-integrated pump with low glucose suspend group, and 0.3 (0.1-0.5)% in the sensor-integrated pump with predictive low glucose management group. In individuals switching from sensor-augmented pump to sensor-integrated pump with low glucose suspend (n=31), there were significant reductions in the monthly rate of hypoglycaemic events <3 mmol/l (rate ratio 0.63, 95% CI 0.45-0.89; P=0.009) and in the percentage of time with glucose values ≤3 mmol/l [sensor-augmented pump: 0.63% (95% CI 0.34-1.29), sensor-integrated pump with low glucose suspend: 0.33% (95% CI 0.16-0.64); P=0.001]. The monthly rate of hypoglycaemic events decreased further in individuals (n=139) switching from sensor-integrated pump with low glucose suspend to sensor-integrated pump with predictive low glucose management [rate ratio 0.82 (95% CI 0.69-0.98); P<0.0274]. Similar results were seen for events <3.9 mmol/l. There was no difference in median time spent in target glucose range. CONCLUSION Real-world UK data show that increasing automation of insulin suspension reduces hypoglycaemia exposure in people with Type 1 diabetes.
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Affiliation(s)
- P Choudhary
- King's College London, School of Life Course Sciences, London, UK
| | - S de Portu
- Medtronic International Trading Sàrl, Tolochenaz, Switzerland
| | - A Arrieta
- Medtronic, Bakken Research Centre, Maastricht, The Netherlands
| | - J Castañeda
- Medtronic, Bakken Research Centre, Maastricht, The Netherlands
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25
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Sørgård B, Iversen MM, Mårtensson J. Continuous glucose monitoring in adults with type 1 diabetes: A balance between benefits and barriers: A critical incident study. J Clin Nurs 2019; 28:3318-3329. [PMID: 31090960 DOI: 10.1111/jocn.14911] [Citation(s) in RCA: 6] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/15/2018] [Revised: 03/12/2019] [Accepted: 04/14/2019] [Indexed: 01/22/2023]
Abstract
AIMS AND OBJECTIVES To describe positively and negatively perceived situations experienced by adults with type 1 diabetes using continuous glucose monitoring and the actions they take to deal with these situations. BACKGROUND Real-time continuous glucose monitoring has been shown to improve glycaemic control and reduce hypoglycaemia. Although many patients with type 1 diabetes report great benefits when using continuous glucose monitoring, a substantial number discontinue using the device. Little is known about the different situations and experiences with the daily use of continuous glucose monitoring that contribute to such differences. DESIGN A descriptive design based on the critical incident technique was used. The study complied with the Consolidated Criteria for Reporting Qualitative Research (COREQ) (see File S1). METHODS Individual interviews were conducted with a purposive sample of 23 adults with type 1 diabetes, including current and former users of continuous glucose monitoring from four different outpatient clinics. RESULTS The participants described that they felt that the use of continuous glucose monitoring was a balance between benefits and barriers, and how, through their actions, they tried to adapt their use of continuous glucose monitoring to fit their lifestyles. Various life events affected and altered the balance between benefits and barriers and thus affected their use of continuous glucose monitoring. CONCLUSIONS Continuous glucose monitoring is perceived as an effective and important tool in the self-management of diabetes type 1. It enables a better everyday life and increased satisfaction with treatment. At the same time, the use of continuous glucose monitoring can be both demanding and challenging. RELEVANCE TO CLINICAL PRACTICE Understanding the complex interplay between perceived benefits, treatment burden and adherence to continuous glucose monitoring use is important for nurses engaged in diabetes care. Education and support regarding the use of continuous glucose monitoring must be based on the understanding and perspectives of the patient to alleviate stress and barriers and enhance self-efficacy. As the use of continuous glucose monitoring can change over time, this must be a continuous process beyond initial training.
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Affiliation(s)
- Beate Sørgård
- Department of Health and Caring Sciences, Faculty of Health and Social Science, Western University of Applied Sciences, Bergen, Norway.,Department of Medicine, Vestre Viken, Baerum Hospital, Oslo, Norway
| | - Marjolein M Iversen
- Department of Health and Caring Sciences, Faculty of Health and Social Science, Western University of Applied Sciences, Bergen, Norway
| | - Jan Mårtensson
- Department of Health and Caring Sciences, Faculty of Health and Social Science, Western University of Applied Sciences, Bergen, Norway.,Department of Nursing, School of Health and Welfare, Western Norway University of Applied Sciences, Bergen, Norway
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Viñals C, Quirós C, Giménez M, Conget I. Real-Life Management and Effectiveness of Insulin Pump with or Without Continuous Glucose Monitoring in Adults with Type 1 Diabetes. Diabetes Ther 2019; 10:929-936. [PMID: 30900146 PMCID: PMC6531534 DOI: 10.1007/s13300-019-0599-1] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/29/2018] [Indexed: 11/03/2022] Open
Abstract
INTRODUCTION To describe and compare the routine use of continuous subcutaneous insulin infusion (CSII) in type 1 diabetes (T1D) patients with and without continuous glucose monitoring (CGM) in routine clinical practice and its relationship with glycemic outcomes. METHODS Retrospective observational case-control study collecting routine use of CSII and CGM in T1D patients between January 2016 and December 2016. Patients with T1D using sensor augmented pump (SAP) were matched by sex and disease duration in a 1:3 ratio with those treated only with CSII. Patients used a Paradigm Veo or 640G Medtronic-Minimed® insulin pump with or without a glucose sensor (Enlite, Medtronic-Minimed®) for at least 12 months. RESULTS A total of 160 subjects with T1D were included, 40 using SAP and 120 on CSII (age 47 ± 12 years, 88 women, diabetes duration 29 ± 9.0 years, 10 ± 4.7 years on CSII, HbA1C 7.6 ± 0.8%). Those in SAP therapy used the sensor 63% of time, performed less self-monitored blood glucose (SMBG)/day (3.3 ± 1.9 vs. 4.5 ± 2.0; p < 0.01), more bolus/day (6.2 ± 3.6 vs. 4.8 ± 1.6; p < 0.05), more basal insulin segment/day (6.5 ± 2.1 vs. 5.9 ± 1.5; p < 0.05), and more suspension time of the pump (97 ± 93 vs. 9.6 ± 20 min/day; p < 0.0001). Regarding metabolic control, SAP therapy patients had lower HbA1c (7.4 ± 0.7 vs. 7.7 ± 0.9%; p = 0.068), lower average SMBG value (151 ± 32 vs. 163 ± 30 mg/dL; p < 0.05), a lower percentage of SMBG values greater than 180 mg/dL (30 ± 19 vs. 37 ± 16%; p < 0.05) with no differences in SMBG values less than 70 mg/dL (12 ± 8.0 vs. 9.8 ± 9.8%; p = 0.33) compared with patients on CSII. There were no differences in bolus wizard targets or in insulin/carbohydrate ratios per day. CONCLUSION In a real-world setting, SAP therapy is associated with more self-adjustments of insulin therapy when compared to CSII alone. This could result in an improvement in glucose control.
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Affiliation(s)
- Clara Viñals
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic, Barcelona, Spain
| | - Carmen Quirós
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic, Barcelona, Spain
- Endocrinology and Nutrition Department, Hospital Universitari Mútua de Tarrasa, Tarrasa, Spain
| | - Marga Giménez
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic, Barcelona, Spain
- IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Barcelona, Spain
- CIBERDEM (CIBER in Diabetes and Associated Metabolic Disorders), Barcelona, Spain
| | - Ignacio Conget
- Diabetes Unit, Endocrinology and Nutrition Department, Hospital Clínic, Barcelona, Spain.
- IDIBAPS (Institut d'Investigacions Biomèdiques August Pi i Sunyer), Barcelona, Spain.
- CIBERDEM (CIBER in Diabetes and Associated Metabolic Disorders), Barcelona, Spain.
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Ida S, Kaneko R, Murata K. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. J Diabetes Res 2019; 2019:4684815. [PMID: 30775385 PMCID: PMC6350576 DOI: 10.1155/2019/4684815] [Citation(s) in RCA: 54] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/02/2018] [Revised: 10/23/2018] [Accepted: 10/28/2018] [Indexed: 11/17/2022] Open
Abstract
In the present study, we aimed to investigate the effects of continuous glucose monitoring (CGM) on blood glucose levels, body weight, blood pressure, and hypoglycaemia in patients with type 2 diabetes mellitus using a meta-analysis of randomized controlled trials (RCTs). A literature search was performed using MEDLINE, Cochrane Controlled Trials Registry, and ClinicalTrials.gov. RCTs using CGM in patients with type 2 diabetes mellitus were then selected. Statistical analysis included calculation of the standardized mean difference (SMD) or risk ratio and 95% confidence intervals (CIs) using a random effects model. After literature search, seven RCTs (669 patients) satisfied the eligibility criteria established herein and were included into the meta-analysis. Compared with the self-monitoring blood glucose group, the CGM group exhibited significantly lower HbA1c levels (SMD, -0.35; 95% CI, -0.59--0.10; P = 0.006) and shorter time spent with hypoglycaemia (SMD, -0.42; 95% CI, -0.70--0.13; P = 0.004). Conversely, no differences in body weight and blood pressure were observed between the groups. CGM in patients with type 2 diabetes mellitus could reduce HbA1c levels and time spent with hypoglycaemia. However, because few RCTs were included in this present study and heterogeneity was also noted, care should be taken when interpreting the results.
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Affiliation(s)
- Satoshi Ida
- Department of Diabetes and Metabolism, Ise Red Cross Hospital, Mie, Japan
| | - Ryutaro Kaneko
- Department of Diabetes and Metabolism, Ise Red Cross Hospital, Mie, Japan
| | - Kazuya Murata
- Department of Diabetes and Metabolism, Ise Red Cross Hospital, Mie, Japan
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28
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De Valk HW, Lablanche S, Bosi E, Choudhary P, Silva JD, Castaneda J, Vorrink L, De Portu S, Cohen O. Study of MiniMed 640G Insulin Pump with SmartGuard in Prevention of Low Glucose Events in Adults with Type 1 Diabetes (SMILE): Design of a Hypoglycemia Prevention Trial with Continuous Glucose Monitoring Data as Outcomes. Diabetes Technol Ther 2018; 20:758-766. [PMID: 30325656 DOI: 10.1089/dia.2018.0222] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
Abstract
BACKGROUND Sensor-integrated pump systems with low-glucose suspend (also known as threshold suspend) functions have markedly transformed the management of type 1 diabetes, but most studies to date have excluded patients at high risk of hypoglycemia. The SMILE study is investigating the efficacy of the MiniMed™ 640G insulin pump with the SmartGuard™ predictive low-glucose management (PLGM) feature in the prevention of hypoglycemia in adults with type 1 diabetes, who are at high risk of hypoglycemia. METHODS SMILE is a prospective, randomized, open-label, controlled trial being undertaken in four European countries and Canada. Following a 2-week run-in phase, eligible participants will be randomized to use either the MiniMed 640G system with continuous glucose monitoring (CGM) and the SmartGuard PLGM feature on continuously for 24 weeks (treatment arm), or the MiniMed 640G without CGM and with blinded continuous glucose measurements between weeks 10-12, 16-18, and 22-24 (control arm). The primary endpoint is the mean number of hypoglycemic events, defined as sensor glucose ≤55 mg/dL (≤3.0 mmol/L) for >20 consecutive minutes. Secondary endpoints include various glycemic indices in the hypoglycemic and hyperglycemic ranges, as well as glycated hemoglobin. Data on patient-reported outcomes such as hypoglycemia awareness and treatment satisfaction will also be collected. CONCLUSIONS It is anticipated that the SMILE study will provide important insights into the effectiveness of SmartGuard technology in adult patients with type 1 diabetes.
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Affiliation(s)
- Harold W De Valk
- 1 Department of Internal Medicine, University Medical Center Utrecht , Utrecht, The Netherlands
| | - Sandrine Lablanche
- 2 Department of Diabetology, Grenoble University Hospital , Grenoble, France
| | - Emanuele Bosi
- 3 Diabetes Research Institute, IRCCS San Raffaele Hospital and San Raffaele Vita Salute University , Milan, Italy
| | - Pratik Choudhary
- 4 Department of Internal Medicine, King's College Hospital , London, United Kingdom
| | - Julien Da Silva
- 5 Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland
| | | | - Linda Vorrink
- 5 Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland
| | - Simona De Portu
- 5 Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland
| | - Ohad Cohen
- 5 Medtronic Diabetes, International Trading Sàrl , Tolochenaz, Switzerland
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29
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Parkin CG. Response to Yu et al. Article "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; 20:635-637. [PMID: 30106604 DOI: 10.1089/dia.2018.0241] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
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Gill M, Zhu C, Shah M, Chhabra H. Health Care Costs, Hospital Admissions, and Glycemic Control Using a Standalone, Real-Time, Continuous Glucose Monitoring System in Commercially Insured Patients With Type 1 Diabetes. J Diabetes Sci Technol 2018; 12:800-807. [PMID: 29737202 PMCID: PMC6134311 DOI: 10.1177/1932296818777265] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/03/2023]
Abstract
BACKGROUND Studies comparing standalone real-time continuous glucose monitoring (rtCGM) to self-monitoring of blood glucose (SMBG) in patients with type 1 diabetes mellitus (T1DM) have found that rtCGM is associated with lower glycated hemoglobin (A1C) levels, yet does not increase the risk of severe hypoglycemia. However, little is known about the relationship between rtCGM and health care costs and utilization. The objective of this study was to compare health care spending, hospital admissions, and A1C levels of patients using rtCGM to that of patients not using rtCGM. METHODS This retrospective, cross-sectional analysis used a large repository of health plan administrative data to compare average health care costs (excluding durable medical equipment), hospital admissions, and A1C levels of those using rtCGM (N = 1027) versus not using rtCGM (N = 32 583). To control for potentially confounding variables, a propensity score method was used to match patients using rtCGM to those not using rtCGM, based on characteristics such as age, gender, and comorbidities. RESULTS Patients using rtCGM spent an average of approximately $4200 less in total health care costs, when compared to patients not using rtCGM ( P < .05). They also experienced fewer hospital admissions ( P < .05) and lower A1C ( P < .05) during the postindex year. CONCLUSIONS Use of rtCGM by patients with T1DM is associated with lower health care costs, fewer hospital admissions, and better glycemic control.
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Affiliation(s)
- Max Gill
- Medtronic–Diabetes, Northridge, CA,
USA
| | - Cyrus Zhu
- Medtronic–Diabetes, Northridge, CA,
USA
- Cyrus Zhu, Medtronic–Diabetes, 18000
Devonshire St, Northridge, CA 941325, USA.
| | - Mona Shah
- Medtronic–Diabetes, Northridge, CA,
USA
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Taylor PJ, Thompson CH, Brinkworth GD. Effectiveness and acceptability of continuous glucose monitoring for type 2 diabetes management: A narrative review. J Diabetes Investig 2018; 9:713-725. [PMID: 29380542 PMCID: PMC6031515 DOI: 10.1111/jdi.12807] [Citation(s) in RCA: 63] [Impact Index Per Article: 9.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/16/2017] [Revised: 01/07/2018] [Accepted: 01/21/2018] [Indexed: 01/05/2023] Open
Abstract
The present narrative review discusses the role of continuous glucose monitoring (CGM) in glycemic and weight control, and lifestyle behavior adherence in adults with type 2 diabetes. A literature search from January 2001 to November 2017 was carried out (MEDLINE, CINAHL, Web of Science and Scopus). Eligible studies were trials evaluating the use of CGM with the aim of achieving glucose control or lifestyle-related treatment adherence over a period of ≥8 weeks in adults with type 2 diabetes compared with usual care or another comparison intervention, or observational trials reporting CGM user experience. A total of 5,542 participants were recruited into 11 studies (eight randomized controlled trials [n = 5,346] and three observational studies [n = 196]). The sample size ranged 6-4,678 participants, the mean age was 51.7-60.0 years and diabetes duration was 2.1-19.2 years, with high heterogeneity between studies. Overall, the available evidence showed, compared with traditional self-monitoring of blood glucose levels, CGM promoted greater reductions in glycated hemoglobin, bodyweight and caloric intake; higher adherence rating to a personal eating plan; and increases in physical activity. High compliance to CGM wear-time and device calibration was reported (>90%). The addition of lifestyle and/or behavioral counseling to CGM appeared to further potentiate these improvements. Preliminary evidence suggests that CGM use promotes glycemic and weight control, and lifestyle behavior adherence in adults with type 2 diabetes. These benefits might be further enhanced with integration of diet, exercise, and glucose excursion education and counseling. However, specific attributes of effective interventions and the application of CGM information for promoting improved outcomes and healthier choices remain unclear.
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Affiliation(s)
- Pennie J Taylor
- CSIRO, Health and BiosecurityAdelaideSouth AustraliaAustralia
- Discipline of MedicineSchool of MedicineUniversity of AdelaideAdelaideSouth AustraliaAustralia
| | - Campbell H Thompson
- Discipline of MedicineSchool of MedicineUniversity of AdelaideAdelaideSouth AustraliaAustralia
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Welsh JB. Role of Continuous Glucose Monitoring in Insulin-Requiring Patients with Diabetes. Diabetes Technol Ther 2018; 20:S242-S249. [PMID: 29916736 DOI: 10.1089/dia.2018.0100] [Citation(s) in RCA: 7] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023]
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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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Gisin V, Chan A, Welsh JB. Manufacturing Process Changes and Reduced Skin Irritations of an Adhesive Patch Used for Continuous Glucose Monitoring Devices. J Diabetes Sci Technol 2018; 12:725-726. [PMID: 29076353 PMCID: PMC6154234 DOI: 10.1177/1932296817738076] [Citation(s) in RCA: 24] [Impact Index Per Article: 3.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/17/2022]
Abstract
Adhesives used for continuous glucose monitoring (CGM) devices can cause skin irritations, which sometimes lead to abandonment of the therapy. A previous sensor manufacturing process involved two separate adhesives-one applied to the skin-facing surface of the fabric patch, and a second, ethyl cyanoacrylate-based adhesive, which secured the plastic transmitter housing to the superficial side of the patch. Our current process for attaching the transmitter housing to the fabric patch uses heatstaking, wherein the housing is heated and pressed against the patch with a specialized assembly apparatus. Heatstaking simplifies the sensor assembly process and obviates the need for the second adhesive, which may lead to lower risk of skin irritation(s) in some patients.
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Affiliation(s)
| | | | - John B. Welsh
- Dexcom, Inc, San Diego, CA, USA
- John B. Welsh, MD, PhD, Dexcom, Inc, 6340 Sequence Dr, San Diego, CA 92121, USA.
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Charleer S, Mathieu C, Nobels F, De Block C, Radermecker RP, Hermans MP, Taes Y, Vercammen C, T'Sjoen G, Crenier L, Fieuws S, Keymeulen B, Gillard P. Effect of Continuous Glucose Monitoring on Glycemic Control, Acute Admissions, and Quality of Life: A Real-World Study. J Clin Endocrinol Metab 2018; 103:1224-1232. [PMID: 29342264 DOI: 10.1210/jc.2017-02498] [Citation(s) in RCA: 128] [Impact Index Per Article: 18.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/18/2017] [Accepted: 01/09/2018] [Indexed: 02/04/2023]
Abstract
CONTEXT Randomized controlled trials evaluating real-time continuous glucose monitoring (RT-CGM) patients with type 1 diabetes (T1D) show improved glycemic control, but limited data are available on real-world use. OBJECTIVE To assess impact of RT-CGM in real-world settings on glycemic control, hospital admissions, work absenteeism, and quality of life (QOL). DESIGN Prospective, observational, multicenter, cohort study. PARTICIPANTS A total of 515 adults with T1D on continuous subcutaneous insulin infusion (CSII) therapy starting in the Belgian RT-CGM reimbursement program. INTERVENTION Initiation of RT-CGM reimbursement. MAIN OUTCOME MEASURE Hemoglobin A1c (HbA1c) evolution from baseline to 12 months. RESULTS Between September 1, 2014, and December 31, 2016, 515 adults entered the reimbursement system. Over this period, 417 (81%) patients used RT-CGM for at least 12 months. Baseline HbA1c was 7.7 ± 0.9% (61 ± 9.8 mmol/mol) and decreased to 7.4 ± 0.8% (57 ± 8.7 mmol/mol) at 12 months (P < 0.0001). Subjects who started RT-CGM because of insufficient glycemic control showed stronger decrease in HbA1c at 4, 8, and 12 months compared with patients who started because of hypoglycemia or pregnancy. In the year preceding reimbursement, 16% of patients were hospitalized for severe hypoglycemia or ketoacidosis in contrast to 4% (P < 0.0005) the following year, with decrease in admission days from 54 to 18 per 100 patient years (P < 0.0005). In the same period, work absenteeism decreased and QOL improved significantly, with strong decline in fear of hypoglycemia. CONCLUSION Sensor-augmented pump therapy in patients with T1D followed in specialized centers improves HbA1c, fear of hypoglycemia, and QOL, whereas work absenteeism and admissions for acute diabetes complications decreased.
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Affiliation(s)
- Sara Charleer
- Department of Endocrinology, University Hospitals Leuven-Katholieke Universiteit Leuven, Leuven, Belgium
- PhD Fellowship Strategic Basic Research of the Research Foundation-Flanders (Fonds Wetenschappelijk Onderzoek), Brussels, Belgium
| | - Chantal Mathieu
- Department of Endocrinology, University Hospitals Leuven-Katholieke Universiteit Leuven, Leuven, Belgium
| | - Frank Nobels
- Department of Endocrinology, Onze-Lieve-Vrouw Hospital Aalst, Aalst, Belgium
| | - Christophe De Block
- Department of Endocrinology, Diabetology and Metabolism, University of Antwerp-Antwerp University Hospital, Antwerp, Belgium
| | - Regis P Radermecker
- Department of Diabetes, Nutrition and Metabolic Disorders, Centre Hospitalier Universitaire Liege-Liege University, Liege, Belgium
| | - Michel P Hermans
- Department of Endocrinology and Nutrition, Cliniques Universitaires St-Luc-Université Catholique de Louvain, Brussels, Belgium
| | - Youri Taes
- Department of Endocrinology, Algemeen Ziekenhuis Sint-Jan Brugge AV, Bruges, Belgium
| | - Chris Vercammen
- Department of Endocrinology, Imelda Hospital Bonheiden, Bonheiden, Belgium
| | - Guy T'Sjoen
- Department of Endocrinology, Ghent University Hospital, Ghent, Belgium
| | - Laurent Crenier
- Department of Endocrinology, Université Libre de Bruxelles-Hôpital Erasme, Brussels, Belgium
| | - Steffen Fieuws
- Department of Public Health and Primary Care, I-BioStat, KU Leuven-University of Leuven and Universiteit Hasselt, Leuven, Belgium
| | - Bart Keymeulen
- Diabeteskliniek, University Hospital Brussels-Vrije Universiteit Brussel, Brussels, Belgium
| | - Pieter Gillard
- Department of Endocrinology, University Hospitals Leuven-Katholieke Universiteit Leuven, Leuven, Belgium
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Lawton J, Blackburn M, Allen J, Campbell F, Elleri D, Leelarathna L, Rankin D, Tauschmann M, Thabit H, Hovorka R. Patients' and caregivers' experiences of using continuous glucose monitoring to support diabetes self-management: qualitative study. BMC Endocr Disord 2018; 18:12. [PMID: 29458348 PMCID: PMC5819241 DOI: 10.1186/s12902-018-0239-1] [Citation(s) in RCA: 96] [Impact Index Per Article: 13.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/30/2017] [Accepted: 02/08/2018] [Indexed: 11/17/2022] Open
Abstract
BACKGROUND Continuous glucose monitoring (CGM) enables users to view real-time interstitial glucose readings and provides information on the direction and rate of change of blood glucose levels. Users can also access historical data to inform treatment decisions. While the clinical and psychological benefits of CGM are well established, little is known about how individuals use CGM to inform diabetes self-management. We explored participants' experiences of using CGM in order to provide recommendations for supporting individuals to make optimal use of this technology. METHODS In-depth interviews (n = 24) with adults, adolescents and parents who had used CGM for ≥4 weeks; data were analysed thematically. RESULTS Participants found CGM an empowering tool because they could access blood glucose data effortlessly, and trend arrows enabled them to see whether blood glucose was rising or dropping and at what speed. This predicative information aided short-term lifestyle planning and enabled individuals to take action to prevent hypoglycaemia and hyperglycaemia. Having easy access to blood glucose data on a continuous basis also allowed participants to develop a better understanding of how insulin, activity and food impacted on blood glucose. This understanding was described as motivating individuals to make dietary changes and break cycles of over-treating hypoglycaemia and hyperglycaemia. Participants also described how historical CGM data provided a more nuanced picture of blood glucose control than was possible with blood glucose self-monitoring and, hence, better information to inform changes to background insulin doses and mealtime ratios. However, while participants expressed confidence making immediate adjustments to insulin and lifestyle to address impending hypoglycaemia and hypoglycaemia, most described needing and expecting health professionals to interpret historical CGM data and determine changes to background insulin doses and mealtime ratios. While alarms could reinforce a sense of hypoglycaemic safety, some individuals expressed ambivalent views, especially those who perceived alarms as signalling personal failure to achieve optimal glycaemic control. CONCLUSIONS CGM can be an empowering and motivational tool which enables participants to fine-tune and optimize their blood glucose control. However, individuals may benefit from psycho-social education, training and/or technological support to make optimal use of CGM data and use alarms appropriately.
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Affiliation(s)
- J. Lawton
- Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
| | - M. Blackburn
- Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
| | - J. Allen
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
- Department of Paediatrics, University of Cambridge, Cambridge, UK
| | | | - D. Elleri
- Royal Hospital for Sick Children, Edinburgh, UK
| | - L. Leelarathna
- Manchester Diabetes Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
| | - D. Rankin
- Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, Edinburgh, UK
| | - M. Tauschmann
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
- Department of Paediatrics, University of Cambridge, Cambridge, UK
| | - H. Thabit
- Manchester Diabetes Centre, Central Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK
| | - R. Hovorka
- Wellcome Trust-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, UK
- Department of Paediatrics, University of Cambridge, Cambridge, UK
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Scaramuzza AE, Arnaldi C, Cherubini V, Piccinno E, Rabbone I, Toni S, Tumini S, Candela G, Cipriano P, Ferrito L, Lenzi L, Tinti D, Cohen O, Lombardo F. Recommendations for the use of sensor-augmented pumps with predictive low-glucose suspend features in children: The importance of education. Pediatr Diabetes 2017; 18:883-889. [PMID: 28101899 DOI: 10.1111/pedi.12503] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 09/21/2016] [Revised: 12/16/2016] [Accepted: 12/22/2016] [Indexed: 11/29/2022] Open
Abstract
Sensor-augmented pumps, which consist of a pump and a continuous glucose monitoring system, offer considerable therapeutic opportunities, despite requiring close attention in the early phase of their use. The aim of this paper is to provide recommendations on the use of a predictive low glucose management (PLGM) system (Minimed 640G™, Medtronic, Northridge, CA, USA) in adolescents with type 1 diabetes either at the start of therapy or during follow-up. Sound clinical recommendations on PLGM are of increasing importance since several recent papers have reported significant clinical improvements in patients with PLGM, especially in adults. These recommendations are based on the experience of a group of pediatric endocrinologists who collaborated to closely and intensively study the on-boarding of adolescent patients with type 1 diabetes on automated systems to gain first-hand experience and peer-to-peer insights in a unique free-living environment. The suggestions provided here are indicative, so can be adapted to the individual realities and experiences of different diabetes centers. However, we believe that close adherence to the proposed scheme is likely to increase the chances of improving the clinical and metabolic outcomes of patients treated with this therapy.
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Affiliation(s)
- Andrea E Scaramuzza
- Division of Pediatrics, ASST Cremona, "Ospedale Maggiore di Cremona,", Cremona, Italy
| | | | - Valentino Cherubini
- Division of Pediatric and Adolescent Diabetes, Department of Women's and Children's Health, AOU Salesi Hospital, Ancona, Italy
| | - Elvira Piccinno
- Division of Pediatric and Adolescent Endocrinology and Diabetes, Hospital Giovanni XXIII, Bari, Italy
| | - Ivana Rabbone
- Department of Pediatrics, University of Turin, Turin, Italy
| | - Sonia Toni
- Juvenile Diabetes Center, Anna Meyer Children's Hospital, Florence, Italy
| | - Stefano Tumini
- Center of Pediatric Diabetology, University of Chieti, Chieti, Italy
| | | | - Paola Cipriano
- Center of Pediatric Diabetology, University of Chieti, Chieti, Italy
| | - Lucia Ferrito
- Division of Pediatric and Adolescent Diabetes, Department of Women's and Children's Health, AOU Salesi Hospital, Ancona, Italy
| | - Lorenzo Lenzi
- Juvenile Diabetes Center, Anna Meyer Children's Hospital, Florence, Italy
| | - Davide Tinti
- Department of Pediatrics, University of Turin, Turin, Italy
| | - Ohad Cohen
- Institute of Endocrinology, Sheba Medical Center, Ramat Gan, Israel
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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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Forlenza GP, Pyle LL, Maahs DM, Dunn TC. Ambulatory glucose profile analysis of the juvenile diabetes research foundation continuous glucose monitoring dataset-Applications to the pediatric diabetes population. Pediatr Diabetes 2017; 18:622-628. [PMID: 27878929 PMCID: PMC7162536 DOI: 10.1111/pedi.12474] [Citation(s) in RCA: 17] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/27/2016] [Revised: 10/18/2016] [Accepted: 10/20/2016] [Indexed: 12/31/2022] Open
Abstract
BACKGROUND Increased continuous glucose monitor (CGM) use presents both the benefit and burden of increased data for clinicians to rapidly analyze. The ambulatory glucose profile (AGP) is an evolving a universal software report for CGM data analysis. OBJECTIVES/HYPOTHESES We utilized the Juvenile Diabetes Research Foundation-CGM dataset to evaluate the AGP across a broad spectrum of patients to show how AGP can be used clinically to assist with CGM-related decision making. We hypothesized that AGP metrics would be different across age and HbA1c strata. SUBJECTS AGPs were generated from the JDRF-CGM trial dataset for all periods during which there were ≥10 days of CGM coverage in the 2 weeks adjacent to an HbA1c measurement yielding 1101 AGPs for 393 unique subjects. METHODS AGPs were stratified by age group (8-14, 15-24, and ≥25 years) and HbA1c (within or above target for age) and compared for between group differences in AGP metrics via two-factor ANOVA. Glycemic differences between time periods were analyzed via segmented regression analysis. RESULTS Glucose exposure (average and estimated A1c) and variability (standard deviation and interquartile range) were different between the low and high HbA1c levels. Within a given HbA1c level all age groups were significantly different from each other with older patients having lower averages with less variability than younger patients. CONCLUSIONS AGP analysis of the JDRF-CGM data highlights significant differences in glycemic profiles between pediatric and adult age groups and between well and less well-controlled patient populations.
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Affiliation(s)
| | - Laura L. Pyle
- Department of Pediatrics, University of Colorado Denver, Denver, Colorado,Department of Biostatistics and Informatics, University of Colorado Denver, Denver, Colorado
| | - David M. Maahs
- Barbara Davis Center, University of Colorado Denver, Denver, Colorado
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Chaugule S, Graham C. Cost-effectiveness of G5 Mobile continuous glucose monitoring device compared to self-monitoring of blood glucose alone for people with type 1 diabetes from the Canadian societal perspective. J Med Econ 2017; 20:1128-1135. [PMID: 28745578 DOI: 10.1080/13696998.2017.1360312] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
Abstract
AIMS To evaluate the cost-effectiveness of real-time continuous glucose monitoring (CGM) compared to self-monitoring of blood glucose (SMBG) alone in people with type 1 diabetes (T1DM) using multiple daily injections (MDI) from the Canadian societal perspective. METHODS The IMS CORE Diabetes Model (v.9.0) was used to assess the long-term (50 years) cost-effectiveness of real-time CGM (G5 Mobile CGM System; Dexcom, Inc., San Diego, CA) compared with SMBG alone for a cohort of adults with poorly-controlled T1DM. Treatment effects and baseline characteristics of patients were derived from the DIAMOND randomized controlled clinical trial; all other assumptions and costs were sourced from published research. The accuracy and clinical effectiveness of G5 Mobile CGM is the same as the G4 Platinum CGM used in the DIAMOND randomized clinical trial. Base case assumptions included (a) baseline HbA1c of 8.6%, (b) change in HbA1c of -1.0% for CGM users vs -0.4% for SMBG users, and (c) disutilities of -0.0142 for non-severe hypoglycemic events (NSHEs) and severe hypoglycemic events (SHEs) not requiring medical intervention, and -0.047 for SHEs requiring medical resources. Treatment costs and outcomes were discounted at 1.5% per year. RESULTS The incremental cost-effectiveness ratio for the base case G5 Mobile CGM vs SMBG was $33,789 CAD/quality-adjusted life-year (QALY). Sensitivity analyses showed that base case results were most sensitive to changes in percentage reduction in hypoglycemic events and disutilities associated with hypoglycemic events. The base case results were minimally impacted by changes in baseline HbA1c level, incorporation of indirect costs, changes in the discount rate, and baseline utility of patients. CONCLUSIONS The results of this analysis demonstrate that G5 Mobile CGM is cost-effective within the population of adults with T1DM using MDI, assuming a Canadian willingness-to-pay threshold of $50,000 CAD per QALY.
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Battelino T, Nimri R, Dovc K, Phillip M, Bratina N. Prevention of Hypoglycemia With Predictive Low Glucose Insulin Suspension in Children With Type 1 Diabetes: A Randomized Controlled Trial. Diabetes Care 2017; 40:764-770. [PMID: 28351897 DOI: 10.2337/dc16-2584] [Citation(s) in RCA: 116] [Impact Index Per Article: 14.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/03/2016] [Accepted: 03/07/2017] [Indexed: 02/03/2023]
Abstract
OBJECTIVE To investigate whether predictive low glucose management (PLGM) of the MiniMed 640G system significantly reduces the rate of hypoglycemia compared with the sensor-augmented insulin pump in children with type 1 diabetes. RESEARCH DESIGN AND METHODS This randomized, two-arm, parallel, controlled, two-center open-label study included 100 children and adolescents with type 1 diabetes and glycated hemoglobin A1c ≤10% (≤86 mmol/mol) and using continuous subcutaneous insulin infusion. Patients were randomly assigned to either an intervention group with PLGM features enabled (PLGM ON) or a control group (PLGM OFF), in a 1:1 ratio, all using the same type of sensor-augmented insulin pump. The primary end point was the number of hypoglycemic events below 65 mg/dL (3.6 mmol/L), based on sensor glucose readings, during a 14-day study treatment. The analysis was performed by intention to treat for all randomized patients. RESULTS The number of hypoglycemic events below 65 mg/dL (3.6 mmol/L) was significantly smaller in the PLGM ON compared with the PLGM OFF group (mean ± SD 4.4 ± 4.5 and 7.4 ± 6.3, respectively; P = 0.008). This was also true when calculated separately for night (P = 0.025) and day (P = 0.022). No severe hypoglycemic events occurred; however, there was a significant increase in time spent above 140 mg/dL (7.8 mmol/L) in the PLGM ON group (P = 0.0165). CONCLUSIONS The PLGM insulin suspension was associated with a significantly reduced number of hypoglycemic events. Although this was achieved at the expense of increased time in moderate hyperglycemia, there were no serious adverse effects in young patients with type 1 diabetes.
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Affiliation(s)
- Tadej Battelino
- Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia .,Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - Revital Nimri
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel
| | - Klemen Dovc
- Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia
| | - Moshe Phillip
- The Jesse Z and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children's Medical Center, Petah Tikva, Israel.,Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
| | - Natasa Bratina
- Department of Pediatric Endocrinology, Diabetes and Metabolism, University Medical Centre-University Children's Hospital, Ljubljana, Slovenia
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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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Haviland N, Walsh J, Roberts R, Bailey TS. Update on Clinical Utility of Continuous Glucose Monitoring in Type 1 Diabetes. Curr Diab Rep 2016; 16:115. [PMID: 27718171 DOI: 10.1007/s11892-016-0808-5] [Citation(s) in RCA: 19] [Impact Index Per Article: 2.1] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
Since the early 2000s, continuous glucose monitoring (CGM) technology has advanced to become a standard of care in the treatment of type 1 diabetes. Unfortunately, CGM use is not commonly integrated into practice. This article will review the history, technology, and need for systematic training in CGM. Additionally, it will review recent clinical trial data demonstrating the benefits that CGM offers to all people with type 1 diabetes and the clinicians who care for them.
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Affiliation(s)
- Nalani Haviland
- Advanced Metabolic Care and Research, 625 W. Citracado Pkwy, Ste 108, Escondido, CA, 92025, USA
| | - John Walsh
- Advanced Metabolic Care and Research, 625 W. Citracado Pkwy, Ste 108, Escondido, CA, 92025, USA
| | - Ruth Roberts
- Diabetes Services, Inc., 1030 West Upas St., San Diego, CA, 92103, USA
| | - Timothy S Bailey
- AMCR Institute, 625 West Citracado Parkway Suite 112, Escondido, CA, 92025, USA.
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Jiang FX, Morahan G. Insulin-secreting β cells require a post-genomic concept. World J Diabetes 2016; 7:198-208. [PMID: 27226815 PMCID: PMC4873311 DOI: 10.4239/wjd.v7.i10.198] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/28/2015] [Accepted: 03/18/2016] [Indexed: 02/05/2023] Open
Abstract
Pancreatic insulin-secreting β cells are essential in maintaining normal glucose homeostasis accomplished by highly specialized transcription of insulin gene, of which occupies up to 40% their transcriptome. Deficiency of these cells causes diabetes mellitus, a global public health problem. Although tremendous endeavors have been made to generate insulin-secreting cells from human pluripotent stem cells (i.e., primitive cells capable of giving rise to all cell types in the body), a regenerative therapy to diabetes has not yet been established. Furthermore, the nomenclature of β cells has become inconsistent, confusing and controversial due to the lack of standardized positive controls of developmental stage-matched in vivo cells. In order to minimize this negative impact and facilitate critical research in this field, a post-genomic concept of pancreatic β cells might be helpful. In this review article, we will briefly describe how β cells were discovered and islet lineage is developed that may help understand the cause of nomenclatural controversy, suggest a post-genomic definition and finally provide a conclusive remark on future research of this pivotal cell.
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Affiliation(s)
- Tadej Battelino
- 1 UMC-University Children's Hospital, University of Ljubljana , Slovenia
- 2 Faculty of Medicine, University of Ljubljana , Slovenia
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Battelino T, Liabat S, Veeze HJ, Castañeda J, Arrieta A, Cohen O. Routine use of continuous glucose monitoring in 10 501 people with diabetes mellitus. Diabet Med 2015; 32:1568-74. [PMID: 26042926 PMCID: PMC4744771 DOI: 10.1111/dme.12825] [Citation(s) in RCA: 47] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 06/01/2015] [Indexed: 01/04/2023]
Abstract
AIMS To analyse blood glucose control according to continuous glucose monitoring use in data from the CareLink database, and to identify factors associated with continuation of sensor use during sensor-augmented pump therapy. METHODS The analysis used data from 10 501 people with Type 1 and 2 diabetes mellitus, of whom 7916 (61.7%) had used glucose sensors for ≥ 15 days during any 6-month period over a 2-year observation period. Data were analysed according to the extent of sensor use ( < 25%, 25-49%, 50-74% and ≥ 75% of the time). Time to discontinuation of sensor use was also analysed in new users of glucose sensors. RESULTS Compared with patients in the lowest sensor usage group and non-users, the highest glucose sensor usage group had significantly (P < 0.0001) lower mean blood glucose and blood glucose sd, were more likely to achieve a mean blood glucose concentration < 8.6 mmol/l, (odds ratio 1.5, 95% CI 1.3-1.7; P < 0.0001), and had 50% fewer hypoglycaemic (blood glucose concentration < 2.8 mmol/l) episodes. Among new users, sensor use during the first month of therapy was an important predictor of subsequent discontinuation. Lack of full reimbursement was also significantly associated with early discontinuation, whereas measures of glycaemic control were predictive of discontinuation during long-term treatment. CONCLUSIONS The use of continuous glucose monitoring was significantly associated with reductions in hypoglycaemia and improved metabolic control during insulin pump therapy. Sensor use during the first month was strongly associated with long-term adherence; patient education and training may be helpful in achieving this.
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MESH Headings
- Blood Glucose/analysis
- Canada
- Cohort Studies
- Diabetes Mellitus, Type 1/blood
- Diabetes Mellitus, Type 1/drug therapy
- Diabetes Mellitus, Type 1/economics
- Diabetes Mellitus, Type 2/blood
- Diabetes Mellitus, Type 2/drug therapy
- Diabetes Mellitus, Type 2/economics
- Drug Resistance
- Europe
- Health Information Exchange
- Humans
- Hyperglycemia/prevention & control
- Hypoglycemia/chemically induced
- Hypoglycemia/prevention & control
- Hypoglycemic Agents/administration & dosage
- Hypoglycemic Agents/adverse effects
- Hypoglycemic Agents/therapeutic use
- Insulin/administration & dosage
- Insulin/adverse effects
- Insulin/therapeutic use
- Insulin Infusion Systems/adverse effects
- Insurance, Health, Reimbursement
- Israel
- Monitoring, Ambulatory/economics
- Patient Compliance
- Practice Patterns, Physicians'
- Time Factors
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Affiliation(s)
- T Battelino
- University Medical Centre Ljubljana, Ljubljana, Slovenia
- Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
| | - S Liabat
- Medtronic International Trading Sàrl, Tolochenaz, Switzerland
| | - H J Veeze
- Diabeter, Centre for Pediatric and Adolescent Diabetes Care and Research, Rotterdam, The Netherlands
| | - J Castañeda
- Medtronic Bakken Research Center, Maastricht, The Netherlands
| | - A Arrieta
- Medtronic Bakken Research Center, Maastricht, The Netherlands
| | - O Cohen
- Chaim Sheba Medical Centre, Ramat Gan, Israel
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