Aim: To evaluate the safety and efficacy of faster insulin aspart (FA) vs. insulin aspart (A) in T2D using fully closed-loop (CL) glucose control.
Methods: Fifteen adults (5 females, age 59±10 years, BMI 34.5±9.1kg/m2) with insulin-treated T2D (HbA1c 7.7±1.2% [60±13mM/mol], insulin dose 1.0±0.7U/kg) underwent two 22h-visits (1900-1700) receiving CL with either FA or A in a double-blind randomized crossover design. Basal-bolus regimen was replaced by model predictive control algorithm-directed s/c administration of FA or A based on sensor glucose levels. After an overnight stay, participants consumed matched breakfast and lunch and performed a 20 min-walk. Plasma glucose measurements every 15 min over 10h (0700-1700) evaluated CL performance.
Results: The proportion of time when plasma glucose was in target range from 5.6-10.0mM did not differ between FA and A (primary endpoint, p=0.17, Table). Mean glucose and glucose variability were comparable, as was time spent below and above target. The 2h-postprandial glucose increment was comparable after breakfast and significantly lower after lunch with FA vs. A (p=0.78 and p=0.047). One hypoglycaemic event (<3.5mM) occurred with FA and two with A. Insulin dose was significantly higher with FA vs. A (p=0.021).
Conclusion: Short-term use of fully CL with FA vs. A requires higher insulin doses to achieve comparable glucose control.
L. Bally: None. D. Herzig: None. M.E. Wilinska: None. Y. Ruan: None. A. Vogt: None. M.M. Wertli: None. B. Vogt: None. C. Stettler: None. R. Hovorka: Advisory Panel; Self; Novo Nordisk A/S. Research Support; Self; Abbott, Dexcom, Inc., Medtronic. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk A/S. Other Relationship; Self; B. Braun Medical Inc., Medtronic.
UDEM Scientific Fund; Swiss Diabetes Foundation; Diabetes Centre Bern