Automated blood glucose control with insulin and glucagon in patients with type 1 diabetes

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-001631-31-DK

Enrollment

Registered

2019-04-26

Start date

2019-07-10

Completion date

Unknown

Last updated

2022-05-30

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: 20.0 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 = 18 years - T1D = 2 years - Insulin pump therapy = 1 - Currently using FiAsp® - insulin - HbA1c = 8.5% (69 mmol/mol) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Pregnancy or nursing - Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption - Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) - Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l) - Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation - History of coronary artery disease or congestive heart failure - Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia - Allergy to glucagon or lactose - Pheochromocytoma - Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation Withdrawal criteria - In case of pregnancy (or desire for pregnancy), female subjects are withdrawn - Lack of compliance to any of the important study procedures in the discretion of the investigator - Unacceptable adverse effects in the discretion of the investigator - Withdrawal on participants request will be accepted at any time without further justification

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* Number of CHO interventions to treat hypoglycemia* ;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 33-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* Number of CHO interventions to treat hypoglycemia* ;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 33-hours

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Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes between single- and dual-hormone closed-loop system: - Percentage of time with glucose values 70 %, (2) time in alert hypoglycemia ( 10.0 mmol/l measured by CGM and YSI* - Percentage of time with glucose values < 3.0 mmol/l as measured by CGM and YSI* - Number of hypoglycemic episodes overnight and during daytime* - Nadir blood glucose value for each hypoglycemic episode as measured by CGM and YSI - Duration of each hypoglycemic event as measured by YSI and CGM - CGM glycemic variability measured as SD and CV during overnight and during daytime* - Low Blood Glucose Index (LBGI) overnight and during daytime CGM* - Percentage of participants with a mean blood glucose value (YSI and CGM) = 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol) - Percentage of patients with a mean blood glucose value (YSI and CGM) = their standard therapy mean glucose value (calculated based on HbA1c measurement) - Mean Absolute Relative Difference (MARD) between CGM and YSI glucose* - Mean blood pressure over the study period - Mean pulse rate over the study period - Mean nausea level (VAS) - Mean insulin dose - Mean bolus insulin dose - Mean basal insulin dose - Mean glucagon dose - CHO counting ability (pictures vs. actual meals) - Self-assessment of glucose levels (Clarke Error Grid) - Raw acceleration measured by ActiGraph GT9X Link - Energy expenditure measured by ActiGraph GT9X Link - Steps taken measured by ActiGraph GT9X Link - Physical activity intensity measured by ActiGraph GT9X Link - Heart rate R-R intervals measured by ActiGraph GT9X Link - Sleep latency measured by ActiGraph GT9X Link - Total sleep time measured by ActiGraph GT9X Link - Sleep efficiency measured by ActiGraph GT9X Link - Mean Borg scale level during exercise - Diabetes Treatment Satisfaction Questionnaires, DTSQ - Diabetes Technology Questionnaire, DTQ - Hypoglycemia fear survey, HFS;Timepoint(s) of evaluation of this end point: Evaluation is per	—

Measure

Time frame

Secondary end point(s): Secondary outcomes between single- and dual-hormone closed-loop system: - Percentage of time with glucose values 70 %, (2) time in alert hypoglycemia ( 10.0 mmol/l measured by CGM and YSI* - Percentage of time with glucose values < 3.0 mmol/l as measured by CGM and YSI* - Number of hypoglycemic episodes overnight and during daytime* - Nadir blood glucose value for each hypoglycemic episode as measured by CGM and YSI - Duration of each hypoglycemic event as measured by YSI and CGM - CGM glycemic variability measured as SD and CV during overnight and during daytime* - Low Blood Glucose Index (LBGI) overnight and during daytime CGM* - Percentage of participants with a mean blood glucose value (YSI and CGM) = 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol) - Percentage of patients with a mean blood glucose value (YSI and CGM) = their standard therapy mean glucose value (calculated based on HbA1c measurement) - Mean Absolute Relative Difference (MARD) between CGM and YSI glucose* - Mean blood pressure over the study period - Mean pulse rate over the study period - Mean nausea level (VAS) - Mean insulin dose - Mean bolus insulin dose - Mean basal insulin dose - Mean glucagon dose - CHO counting ability (pictures vs. actual meals) - Self-assessment of glucose levels (Clarke Error Grid) - Raw acceleration measured by ActiGraph GT9X Link - Energy expenditure measured by ActiGraph GT9X Link - Steps taken measured by ActiGraph GT9X Link - Physical activity intensity measured by ActiGraph GT9X Link - Heart rate R-R intervals measured by ActiGraph GT9X Link - Sleep latency measured by ActiGraph GT9X Link - Total sleep time measured by ActiGraph GT9X Link - Sleep efficiency measured by ActiGraph GT9X Link - Mean Borg scale level during exercise - Diabetes Treatment Satisfaction Questionnaires, DTSQ - Diabetes Technology Questionnaire, DTQ - Hypoglycemia fear survey, HFS;Timepoint(s) of evaluation of this end point: Evaluation is per

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Countries

Denmark

Contacts

Public ContactAjenthen Ranjan

Steno Diabetes Center Copenhagen

Ajenthen.Ranjan@regionh.dk4523742766

Outcome results

None listed

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