Overview

Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes

Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Steno Diabetes Center Copenhagen
Collaborators:
Herlev Hospital
Technical University of Denmark
Treatments:
Glucagon
Criteria
Inclusion Criteria:

- Age = 13-17 years

- T1D duration ≥ 2 years

- Insulin pump therapy ≥ 1 year

- Using CGM or isCGM (Flash Libre)

- HbA1c ≤ 9.0% (75 mmol/mol)

- Using carbohydrate counting

Exclusion Criteria:

- Allergy to glucagon or lactose

- Allergy to faster insulin aspart (FiAsp)

- Pheochromocytoma

- Self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l

- Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and
meal intake

- Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate
contraceptive methods (intrauterine device, contraceptive pill, patch or injection)

- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs
affecting glucose metabolism during or within 30 days prior to study participation

- Other concomitant medical or psychological condition that according to the
investigator's assessment makes the participant unsuitable for study participation