drugset / Trial / NCT04949867
Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes
Phase 4
Completed
11 enrolled
Steno Diabetes Center Copenhagen
Herlev Hospital · collabTechnical University of Denmark · collab
RandomizedCrossoverSingle-blindTreatment
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).
Timeline
- Start
- 2021-05-20
- Primary completion
- 2022-04-26
- Completion
- 2022-04-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Glucagon | Peptide | — | — |