Testing of an artificial pancreas system with insulin and glucagon in adolescents with type 1 diabetes

Phase 1

• Conditions: Patients with type 1 diabetes; MedDRA version: 21.1Level: LLTClassification code 10012608Term: Diabetes mellitus insulin-dependentSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2020-005836-31-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-23
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.;Secondary Objective: Not applicable;Primary end point(s): Percentage of time with glucose values < 3.9 mmol/l as measured by CGM* <br>;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 26-hours