Controlling glycemic variability in people living with type 1 diabetes receiving insulin glargine 300 U/mL (Gla-300).

Short-term glycemic variability is associated with the risk of hypoglycemia and hyperglycemia in people living with type 1 diabetes and can potentially affect clinical outcomes. Continuous glucose monitoring (CGM) is of increasing importance to evaluate glycemic variability in greater detail. Specific metrics for assessing glycemic variability were proposed, such as the SD of mean glucose level and associated coefficient of variation, and time in target glucose range to guide study designs, therapy and allow people with diabetes more transparency in interpreting their own CGM data. Randomized controlled trials (RCT) and real-world evidence provide complementary information about the efficacy/effectiveness and safety of interventions. Insulin glargine 300 U/mL (Gla-300) has a longer lasting and less variable action than insulin glargine U100 (Gla-100) with a lower risk of hypoglycemia. While insulin degludec U100 (iDeg-100) was associated with lower glucose values but more time below range in one randomized study compared with Gla-300, Gla-300 was associated with a higher per cent time in range, but also above the therapeutic range. However, a real-world study did not find differences during the day between Gla-300 and iDeg-100. The upcoming InRange RCT is the first head-to-head comparison of Gla-300 with iDeg-100 using CGM in an international population using CGM metrics as the primary endpoint. The non-interventional COMET-T real-world study will determine the real-world effectiveness of Gla-300 using CGM metrics and cover a broad spectrum of clinical practice decisions irrespective of the prior basal insulin.

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Competing interests: JKM is a member of the advisory board of Abbott Diabetes Care, Boehringer Ingelheim, Becton-Dickinson, Eli Lilly, Medtronic, Novo Nordisk, Prediktor, Roche Diabetes Care, and Sanofi-Aventis and received speaker honoraria from Abbott Diabetes Care, AstraZeneca, Becton-Dickinson, DexCom, Eli Lilly, MSD, Novo Nordisk, Roche Diabetes Care, Sanofi, and Servier. JKM is a shareholder of decide Clinical Software. TD has received speaker’s honoraria and research support from or has consulted for Abbott, AstraZeneca, Boehringer, DexCom, Lilly, Medtronic, Novo Nordisk, Roche, Sanofi and Ypsomed and is a shareholder of DreaMed Ltd. SG has received speaker’s honoraria from Sanofi, Eli Lilly, Novo Nordisk, Abbott Diabetes Care, AstraZeneca, DexCom, VitalAire, Berlin Chemie-Menarini, Pfizer, MSD, Ascensia, and Amgen and has consulted for Abbott Diabetes Care, Roche, Medtronic, Berlin Chemie-Menarini and EvivaMed. SG has volunteered for the German Diabetes Society (Deutsche Diabetes Gesellschaft) and Diabetology Working Group Baden-Württemberg (Arbeitsgemeinschaft Diabetologie Baden-Württemberg). SB is a member of the advisory board of Amgen, Novartis, Sanofi, Novo Nordisk, and Daiichi Sankyo and has received speaker’s honoraria from Amgen, AstraZeneca, Boehringer Ingelheim, Daiichi Sankyo, Novartis, Novo Nordisk, and Sanofi. PB has received research funding and honoraria for consultancy from a number of companies including AstraZeneca, Bayer, Boehringer, Roche, and Sanofi.