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

Dual-Hormone Closed-Loop Glucose Control in Adolescents with Type 1 Diabetes - Dual-Hormone Closed-Loop 2021

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005836-31-DK

Enrollment

Registered

2021-02-23

Start date

2021-04-07

Completion date

Unknown

Last updated

2022-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with type 1 diabetes MedDRA version: 21.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861

Interventions

Trade Name: GlucaGen Product Name: GlucaGen Product Code: SUB02347MIG Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: GLUCAGON CAS Number: 16941-32-5 Concentra

Eligibility

Sex/Gender

All

Inclusion 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 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

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

Design outcomes

Primary

Measure	Time frame
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* ;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	—

Measure

Time frame

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* ;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

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Secondary

Measure	Time frame
Secondary end point(s): Carbohydrate outcomes • Number of carbohydrate interventions to treat hypoglycemia* Glucose outcomes • Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by CGM and YSI* • Percentage of time with glucose values 13.9 mmol/l measured by CGM and YSI* • Percentage of time with glucose values 70 %, (2) time in alert hypoglycemia (10 from baseline) for o Nausea o Headache o Palpitation • Number of vomits Other: • Difference between actual and participant-estimated CHO content in meals • Mean Borg scale level during exercise • Physical activity intensity measured by ActiGraph GT9X Link • Sleep efficiency measured by ActiGraph GT9X Link;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	—

Measure

Time frame

Secondary end point(s): Carbohydrate outcomes • Number of carbohydrate interventions to treat hypoglycemia* Glucose outcomes • Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by CGM and YSI* • Percentage of time with glucose values 13.9 mmol/l measured by CGM and YSI* • Percentage of time with glucose values 70 %, (2) time in alert hypoglycemia (10 from baseline) for o Nausea o Headache o Palpitation • Number of vomits Other: • Difference between actual and participant-estimated CHO content in meals • Mean Borg scale level during exercise • Physical activity intensity measured by ActiGraph GT9X Link • Sleep efficiency measured by ActiGraph GT9X Link;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

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Countries

Denmark

Contacts

Public ContactAjenthen G Ranjan

Steno Diabetes Center Copenhagen

Ajenthen.Ranjan@regionh.dk4523742766

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026