Comparable Glucose Control with Fast-Acting Insulin Aspart Versus Insulin Aspart Using a Second-Generation Hybrid Closed-Loop System During Exercise

Abstract

<b><i>Background:</i></b> This study compared glucose control with fast-acting insulin aspart (FiAsp) versus insulin aspart following moderate-intensity exercise (MIE) and high-intensity exercise (HIE) using a second-generation closed-loop (CL) system in people with type 1 diabetes. <b><i>Materials and Methods:</i></b> This randomized crossover study compared FiAsp versus insulin aspart over four sessions during MIE and HIE with CL insulin delivery by the MiniMed™ Advanced hybrid CL system. Participants were randomly assigned FiAsp and insulin aspart each for 6 weeks and within each period performed, in random order, 40 min MIE (∼50% VO₂max) and HIE (6 × 2 min ∼80% VO₂max; 5 min recovery). The primary outcome was continuous glucose monitoring (CGM) time in range (TIR, 3.9-10.0 mM) for 24 h following exercise. <b><i>Results:</i></b> Sixteen adults (9 male; age 48 [37, 57] years; hemoglobin A1c (HbA1c) 7.0 [6.4, 7.2] %; duration diabetes 30 [17, 41] years) were recruited. In the 24 h postexercise, median TIR was >81%, time in hypoglycemia (<3.9 mM) was <4%, and time in hyperglycemia (>10 mM) was <17% for both exercise conditions and insulin formations, with no significant differences between insulins (<i>P</i> > 0.05). In the 2 h postexercise and overnight, the TIR approached 100% for all conditions. <b><i>Conclusions:</i></b> There were no differences in TIR during and 24 h after MIE or HIE when comparing insulin aspart with FiAsp delivered by a second-generation CL system. Insulin formulations with an offset in action greater than FiAsp are needed to provide a meaningful improvement in CL glucose control with exercise. Clinical Trial Registration number: ACTRN12619000469112.