Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Objective:
To assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system
compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type
1 diabetes.
Methods:
In a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1
diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop
control. During each study period, participants will have one overnight stay, received three
meals and performed exercise for 45 min (bicycle with estimated 50% V02max).
Endpoint:
The primary endpoint is sensor-derived percentage of time in hypoglycemia (<3.9 mmol/L).