Background: The trial aim was to compare the efficacy of real-time and intermittently-scanned continuous glucose monitoring (rtCGM and isCGM, respectively) in maintaining optimal glycemic control.
Methods: In this randomized study, adults with T1D and normal hypoglycemia awareness (GOLD score <4) used rtCGM (Guardian Connect Mobile) or isCGM (Freestyle Libre) during 4 days of physical activity (sport period) and in the subsequent 4 weeks (home period). Main endpoints were time in hypoglycemia (<3.9 mmol/l [<70 mg/dl]) and time in range (3.9-10.0 mmol/l [70-180 mg/dl]). To check for bias between the different sensors used by the rtCGM and isCGM systems, the isCGM group wore an additional blinded Enlite sensor (iPro2) for 6 days.
Results: Sixty adults with T1D (age 38±13 years, HbA1c 7.8±1.1% [62±12 mmol/mol]) were randomized to rtCGM (n=30) or isCGM (n=30). All participants completed the study. Time in hypoglycemia (<3.9 mmol/l) was lower among rtCGM participants in the sport period (6.8±5.5% vs. 11.4±8.6%, respectively; p=0.018) and the home period (5.3±2.5% vs. 7.3±4.4%, respectively; p=0.035). Hypoglycemia differences were significant and most notable during the night. rtCGM participants spent more time in range than isCGM participants throughout both the sport (78.5±10.2% vs. 69.7±16%, respectively; p=0.0149) and home (75.6±9.7% vs. 67.4±17.8%, respectively; p=0.0339) periods. The results were robust to the insignificant bias between rtCGM and isCGM sensors that blinded CGM found in the isCGM arm.
Conclusion: rtCGM was superior to isCGM in preventing hypoglycemia and improving time in range in T1D adults with normal hypoglycemia awareness, demonstrating the value of rtCGM alarms during exercise and in daily diabetes self-management.
J. Soupal: Advisory Panel; Self; Abbott. Consultant; Self; Medtronic, Roche Diabetes Care. Speaker’s Bureau; Self; Dexcom, Inc. A. Hásková: None. G. Grunberger: Research Support; Self; Medtronic. L. Petruzelkova: None. C. Parkin: Consultant; Self; Abbott, CeQur Corporation, Dexcom, Inc., DreaMed Diabetes, Novo Nordisk Inc., Onduo, Roche Diabetes Care, Valeritas, Inc. J. Skrha: Advisory Panel; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp. L. Radovnická: None. E. Horova: None. M. Prazny: Speaker’s Bureau; Self; Novartis Pharmaceuticals Corporation, Roche Diabetes Care. Other Relationship; Self; Abbott, Boehringer Ingelheim International GmbH, Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi, Teva Pharmaceutical Industries Ltd.
15-26705A (Program RVO-VFN00064165)