The Association Between HbA1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4) (original) (raw)
Clinical Care / Education / Nutrition / Psychosocial Research| July 08 2020
1Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden
2Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
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1Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden
2Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
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3Statistiska Konsultgruppen, Gothenburg, Sweden
4Department of Ophthalmology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
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1Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden
2Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
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1Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden
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5Division of Metabolism, Endocrinology, and Nutrition, University of Washington, Seattle, WA
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6Department of Medical Sciences, Uppsala University, Uppsala, Sweden
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7Type 1 Diabetes & Functional Insulins, Novo Nordisk A/S, Søborg, Denmark
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9Department of Medicine, University of California, San Diego, La Jolla, CA
10Behavioral Diabetes Institute, San Diego, CA
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11Department of Internal Medicine and Department of Health, Medicine and Caring Sciences, Linköping University, Norrköping, Sweden
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12Department of Medicine, Örebro University Hospital, Örebro, Sweden
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1Department of Medicine, NU-Hospital Group, Trollhättan/Uddevalla, Sweden
2Department of Molecular and Clinical Medicine, University of Gothenburg, Gothenburg, Sweden
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Diabetes Care 2020;43(9):2017–2024
Citation
Shilan Seyed Ahmadi, Klara Westman, Aldina Pivodic, Arndís F. Ólafsdóttir, Sofia Dahlqvist, Irl B. Hirsch, Jarl Hellman, Magnus Ekelund, Tim Heise, William Polonsky, Magnus Wijkman, Erik Schwarcz, Marcus Lind; The Association Between HbA1c and Time in Hypoglycemia During CGM and Self-Monitoring of Blood Glucose in People With Type 1 Diabetes and Multiple Daily Insulin Injections: A Randomized Clinical Trial (GOLD-4). _Diabetes Care 1 September 2020; 43 (9): 2017–2024. https://doi.org/10.2337/dc19-2606
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OBJECTIVE
According to recent guidelines, individuals with type 1 diabetes should spend <4.0% of time per day with glucose levels <3.9 mmol/L (<70 mg/dL) and <1.0% per day with glucose levels <3.0 mmol/L (<54 mg/dL).
RESEARCH DESIGN AND METHODS
In the GOLD randomized crossover trial, 161 individuals with type 1 diabetes treated with multiple daily insulin injections (MDI) were randomized to continuous glucose monitoring (CGM) or conventional therapy with self-monitoring of blood glucose (SMBG) and evaluated over 16 months. We estimated the association between time spent in hypoglycemia and various mean glucose and HbA1c levels.
RESULTS
Time spent in hypoglycemia (<3.9 mmol/L and <3.0 mmol/L) increased significantly with lower mean HbA1c and mean glucose levels during both CGM and conventional therapy. During CGM, 24 (57.1%) individuals with HbA1c <7.5% (<58 mmol/mol) had <1.0% time spent in hypoglycemia <3.0 mmol/L and 23 (54.8%) had <4.0% time spent in hypoglycemia <3.9 mmol/L. During CGM, mean time spent in hypoglycemia for individuals with mean HbA1c 7.0% (52 mmol/mol) was estimated to be 5.4% for <3.9 mmol/L and 1.5% for <3.0 mmol/L. The corresponding values during SMBG were 9.2% and 3.5%, respectively. Individuals with mean glucose levels of 8 mmol/L spent 4.9% units more time with glucose levels <3.9 mmol/L and 2.8% units more time <3.0 mmol/L during SMBG compared with CGM.
CONCLUSIONS
Reaching current targets for time in hypoglycemia while at the same time reaching HbA1c targets is challenging for patients with type 1 diabetes treated with MDI both with CGM and SMBG monitoring. However, CGM is associated with considerably less time in hypoglycemia than SMBG at a broad range of HbA1c levels and is crucial for patients with MDI treatment if they are to have a chance to approach hypoglycemia targets.
© 2020 by the American Diabetes Association
2020
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