1. 39-LB: A Comparison of Insulin Glargine U300 and Insulin Degludec around Spontaneous Exercise Sessions in People with Type 1 Diabetes—The ULTRAFLEXI-1 Study
- Author
-
OTHMAR MOSER, ALEXANDER MUELLER, FELIX ABERER, FAISAL AZIZ, HARALD KOJZAR, CAREN SOURIJ, ANNA M. OBERMAYER, FARAH M. ABBAS, PHILIPP BIRNBAUMER, MAX L. ECKSTEIN, LUKAS HÖNGER, JACQUELINE LENZ, INES MURSIC, CHRISTOPH STERNAD, MATTHIAS ZANKER, HARIS ZIKO, PETER N. PFERSCHY, NORBERT J. TRIPOLT, and HARALD SOURIJ
- Subjects
Endocrinology, Diabetes and Metabolism ,Internal Medicine - Abstract
Background and aims: Regular physical activity and exercise represent a corner stone in the treatment of type 1 diabetes (T1D) , however, exercise-induced hypoglycemia remains the major barrier to a physically active lifestyle. Therefore, the ULTRAFLEXI-1 study compared two basal insulin analogues, Glargine 300U/ml (IGlar U300) and Degludec (IDeg) , in two different doses (100% and 75% of the regular dose) when used around spontaneous exercise sessions in adults with T1D. Methods: We performed a randomized, single-center, four-period, cross-over trial (EudraCT: 2019-003209-89) and included adults with T1D treated with multiple daily insulin injections and an HbA1c ≤10% (≤86 mmol/mol) . In each of the four 2-weeks-periods, participants attended six spontaneous evening cycling sessions (60 minutes, moderate intensity) . The days of exercising were randomized and announced at 8 A.M. to the participants. The basal insulin used on the exercise days during the four periods were: IGlar U300 100% or 75% of the regular dose or IDeg 100% or 75%, respectively. 100% of the regular basal insulin dose was used at all non-exercise days. CGM was performed using a blinded Dexcom G6 device. The primary outcome was TBR ( Results: 25 people were enrolled (14 male) , aged 41.4±11.9 years, with a mean diabetes duration of 16.8±10.4 years and a mean HbA1c of 7.5±0.8%. (59±9 mmol/mol) . Mean TBR during the 24-hour periods following the exercise sessions was 2.71±2.56% for IGlar U300 (100%) and 4.37%±3.43% for IDeg (100%) (p=0.025) as well as 2.28±2.67% for IGlar U300 compared to 2.55 ±2.87% with IDeg when using the 75% dose on exercise days (p=0.720) . Conclusion: Time spent in hypoglycemia after spontaneous exercise sessions was significantly lower in people with type 1 diabetes receiving IGlar U300 as compared to IDeg when the 100% dose was used. Disclosure O. Moser: Research Support; Dexcom, Inc., Sanofi, Speaker’s Bureau; Medtronic. M. L. Eckstein: None. L. Hönger: None. J. Lenz: None. I. Mursic: None. C. Sternad: None. M. Zanker: None. H. Ziko: None. P. N. Pferschy: None. N. J. Tripolt: None. H. Sourij: Advisory Panel; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk, Research Support; Boehringer Ingelheim International GmbH, Sanofi, Speaker’s Bureau; Amgen Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk. A. Mueller: None. F. Aberer: Other Relationship; Amgen Inc., Boehringer Ingelheim International GmbH, Sanofi. F. Aziz: None. H. Kojzar: None. C. Sourij: None. A. M. Obermayer: None. F. M. Abbas: None. P. Birnbaumer: None. Funding Sanofi-aventis (DCV-2018-12349)
- Published
- 2022
- Full Text
- View/download PDF