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The mean time below range following exercise sessions was significantly lower with IGlar U300 compared to IDEG at the 100% dose.
The time spent in hypoglycemia within 24 hours after spontaneous exercise was significantly lower in patients with type 1 diabetes (T1D) receiving insulin glargine U-300 (IGlar U300) compared to insulin degludec (IfDEG) at the 100% dose, according to new findings.
Meanwhile, there was no difference in the time spent in hypoglycemia observed when 75% of the basal insulin dose was used on the day of exercise.
“Time in range within 24 hours after the exercise session was significantly higher when the 100% dose of iDeg U 100 was used,” wrote study author Harald Sourij, MD, Interdisciplinary Metabolic Medicine Trials Unit, Division of Endocrinology and DIabetology, Medical University of Graz. “No differences in glycemic ranges were observed for the entire 14 day period.”
The late-breaking findings were presented at the American Diabetes Association (ADA) 2022 Scientific Sessions.
Although regular physical activity is crucial to the treatment of T1D, exercise-induced hypoglycemia is a major barrier to an active lifestyle, according to investigators. As such, the ULTRAFLEXI-1 study compared the use of 2 basal insulin analagoues, IGlar U300 and IDeg, at 100% and 75% of the regular dose surrounding spontaneous exercise sessions.
The randomized, single-center, crossover trial included adults with T1D treated with multiple daily insulin injections and an HbA1c of ≤10% (≤86 mmol/mol). Within each of the four 2-week periods, individuals attended 6 spontaneous 60-minute evening cycling sessions with moderate intensity. Each day of exercise was randomized and announced at 8 A.M. to the participant.
On non-exercise days, 100% of the regular basal insulin dose was used, while investigators performed CGM data analysis using a blinded Dexcom G6 device. The primary outcome was identified as the time below range (<70 mg/dL) during the six 24-hour post-exercise periods in the 4 trial arms. They analyzed the difference in time below the range between 100% IGlar and 100% IDeg or 75% IGlar and 75% IDeg in hierarchical order using the repeated measures linear mixed model.
A total of 25 individuals were enrolled in the study, including 14 male patients. They had a mean age of 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).
Data show the mean time below range 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).
Meanwhile, the mean time below range was 2.28±2.67% for IGlar U300 in comparison to 2.55 ±2.87% for IDeg when using the 75% dose on exercise days (P = .720), according to the investigators.
The study, “A Comparison of Insulin Glargine U300 and Insulin Degludec around Spontaneous Exercise Sessions in People with Type 1 Diabetes–The ULTRAFLEXI-1 Study,” was presented at ADA 2022.