An open, controlled investigation of the effect of micro-boluses of glucagon on continuous glucose monitoring in patients with diabetes mellitus type 1.

An open, controlled investigation of the effect of micro-doses of glucagon on the performance of continuous glucose monitoring in patients with diabetes mellitus type 1. - MicroGlucagon study 4

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2022-000800-37-NO

Enrollment

Registered

2022-07-21

Start date

2022-09-06

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Diabetes mellitus type 1

Interventions

Trade Name: Glucagon Novo Nordisk Product Name: Glucagon Novo Nordisk Pharmaceutical Form: Concentrate and solvent for solution for injection Pharmaceutical form of the placebo: Solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. DM1 for at least one year 2. Age 18 – 75 years 3. Last HbA1c =65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. Pregnant women or women trying to conceive 2. Any chronic disease, including major psychiatric diseases, judged incompatible with participation in the study 3. Medication with platelet inhibitor or antcoagulants 4. Clinically significant allergy to adhesives 5. Unfit for participation for any reason as judged by the investigators

Design outcomes

Primary

Measure	Time frame
Main Objective: Test whether micro-doses of glucagon at the site of subcutaneous CGM will reduce the sensing delay, i.e., the time it takes from a certain glucose level is present in the blood and until the same level is reflected in the level measured in subcutaneous interstitial tissue in patients with diabetes mellitus type 1.;Secondary Objective: Not applicable;Primary end point(s): Primary outcome measure will be the time it takes for the CGM to measure a 1.0 mmol/L increase in glucose after the initiation of a meal. The glucagon treated CGM will be compared to the non-treated CGM in the same patient during the same meal. ;Timepoint(s) of evaluation of this end point: Glucose sensing data is stored continuously by the CGM device. All data will be collected on the last study visit (maximum day 14). The end point will be evaluated at all the meals during the study period.	—

Measure

Time frame

Main Objective: Test whether micro-doses of glucagon at the site of subcutaneous CGM will reduce the sensing delay, i.e., the time it takes from a certain glucose level is present in the blood and until the same level is reflected in the level measured in subcutaneous interstitial tissue in patients with diabetes mellitus type 1.;Secondary Objective: Not applicable;Primary end point(s): Primary outcome measure will be the time it takes for the CGM to measure a 1.0 mmol/L increase in glucose after the initiation of a meal. The glucagon treated CGM will be compared to the non-treated CGM in the same patient during the same meal. ;Timepoint(s) of evaluation of this end point: Glucose sensing data is stored continuously by the CGM device. All data will be collected on the last study visit (maximum day 14). The end point will be evaluated at all the meals during the study period.

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary outcomes measures will be any deviation in glucose measurements when the glucagon treated CGM is compared to the control CGM in the same patient during the same meal. Among possible secondary outcome measures are maximum postprandial glucose level measured, time to maximum postprandial glucose level and area under the glucose curve the first 30, 60, 90 and 120 minutes after a meal. Possible differences in thermal camera and laser doppler flowmetry will also be studied. ;Timepoint(s) of evaluation of this end point: Same as primary endpoint	—

Measure

Time frame

Secondary end point(s): Secondary outcomes measures will be any deviation in glucose measurements when the glucagon treated CGM is compared to the control CGM in the same patient during the same meal. Among possible secondary outcome measures are maximum postprandial glucose level measured, time to maximum postprandial glucose level and area under the glucose curve the first 30, 60, 90 and 120 minutes after a meal. Possible differences in thermal camera and laser doppler flowmetry will also be studied. ;Timepoint(s) of evaluation of this end point: Same as primary endpoint

—

Countries

Norway

Contacts

Public ContactNTNU TT

NTNU

contact@tto.ntnu.no+4748224870

Outcome results

None listed

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