Bihormonal fully closed-loop glucose control in adolescents with Type 1 diabetes: an outpatient, randomized, crossover trial.

Abstract

Effective diabetes management in adolescents with Type 1 diabetes is crucial to reduce the risk of long-term complications. However, adolescents show the poorest glycemic outcomes of all age groups. A bihormonal fully closed-loop (FCL) system, which requires no user input, may help address these challenges. In this trial, the performance and safety of a bihormonal FCL system (Inreda&#xae; AP) was evaluated in adolescents. The trial was a single-center, randomized, crossover trial in adolescents with Type 1 diabetes aged 12-18 years. The FCL system was compared with the participants' usual diabetes treatment in a home healthcare setting. The trial consisted of two study periods of 2 weeks, separated by a 2-week washout period. The primary endpoint was time in range (TIR; 3.9-10.0 mmol/L). In total, 20 individuals were enrolled and the data from 15 of them were analyzed. Glucose outcome parameters showed significant improvements during the FCL treatment period. Median TIR was 61.3% [interquartile range (IQR): 53.7%-68.2%] in the control period compared with 74.9% (IQR: 73.1-81.0) during the FCL period (<i>p</i> &lt; 0.001). Additionally, other glucose outcomes including time above range (&gt; 10.0 mmol/L) and median blood glucose were significantly improved in the FCL treatment period. To conclude, this trial provides preliminary evidence that treatment with the bihormonal FCL system may improve glucose outcome parameters, with no safety concerns observed in adolescents with Type 1 diabetes over the short study duration. However, future research should focus on long-term trials with larger study populations to confirm these findings and evaluate the long-term effects of bihormonal FCL treatment in adolescents.