Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

Not Applicable

Completed

Conditions: Hypoglycemia
Type 1 Diabetes

Interventions: Drug: GlucaGen

Registration Number: NCT05379686

Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary: The primary aim of the study is to evaluate the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise in individuals with AHCL-treated T1D.

Detailed Description: The study consists of a screening visit (visit A) and two additional study visits (visit B and visit C) completed in a sequential order. During study visit B participants will receive s.c. administration of 150 ug glucagon prior to a 45-min moderate intensity continuous exercise session and subsequently continue into a 1-hour post-exercise observation period. During study visit C the exact same procedures will be followed with the omission of glucagon.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

Inclusion Criteria

Age ≥ 18 years
Type 1 diabetes ≥ 2 years
Use of AHCL system MiniMed 780G ≥ 4 weeks
Use of Novorapid for ≥ 1 week

Exclusion Criteria

Allergies to lactose or glucagon
Known or suspected allergies to glucagon or related products
History of hypersensitivity or allergic reaction to glucagon or lactose
Patients with diagnosed pheochromocytoma, insulinoma or gastroparesis
Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Lack of compliance with key study procedures at the discretion of the investigator
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrolment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
Inability to understand the individual information and to give informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
150 ug glucagon before exercise	GlucaGen	150 ug glucagon will be administered subcutaneously just before exercise

Primary Outcome Measures

Name	Time	Method
Difference in Percentage of Time in Target Glucose Range (PG: 3.9 - 10.0 mmol/l) During and for 1-hour After Dynamic Physical Exercise Between Visit B and C	0 min to +105 min	This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Secondary Outcome Measures

Name	Time	Method
Difference in Peak PG Concentration Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period.
Difference in Standard Deviation in PG Concentrations Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period.
Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C	0 min to +105 min	This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period.
Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C	0 min to +105 min	This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention.
Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C	0 min to +105 min	This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.
Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C	0 min to +105 min	This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.
Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C	0 min to +105 min	This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period.
Difference in Nadir PG Concentration Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period.
Difference in Incremental Peak PG Concentration Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period.
Difference in Mean PG Concentration Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period.
Difference in PG Area Under the Curve (AUC) Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period.
Difference in Coefficient of Variation in PG Concentrations Between Visit B and C	0 min to +105 min	This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period.