Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

Study Overview
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Brief Summary
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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
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The study consists of a screening visit (visit A), a cardiopulmonary exercise test (visit B) and a study visit (visit C). During study visit C, 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.

Official Title
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Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

Conditions
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Type 1 Diabetes, Hypoglycemia

Intervention / Treatment
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* Drug: GlucaGen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: One-arm open-label intervention study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 150 ug glucagon before exercise<br>150 ug glucagon will be administered subcutaneously just before exercise | Drug: GlucaGen<br>* 150 ug glucagon will be administered to the participants before exercise.<br>* Other names: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time in target glucose range (PG: 3.9 - 10.0 mmol/l) during and for 1-hour after dynamic physical exercise |  | 0 min to +105 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hypoglycaemic events (PG<3.9 mmol/l) |  | 0 min to +105 min | 
| Time (min) to hypoglycaemia (PG<3.9 mmol/l) |  | 0 min to +105 min | 
| Percentage of time below target glucose range (PG<3.9 mmol/l) |  | 0 min to +105 min | 
| Percentage of time above target glucose range (PG>10.0 mmol/l) |  | 0 min to +105 min | 
| Incidence rate of hyperglycaemia (PG>10.0 mmol/l) |  | 0 min to +105 min | 
| Nadir PG concentration |  | 0 min to +105 min | 
| Peak PG concentration |  | 0 min to +105 min | 
| Incremental peak PG concentration |  | 0 min to +105 min | 
| Mean PG concentration |  | 0 min to +105 min | 
| PG Area Under the Curve (AUC) |  | 0 min to +105 min | 
| Standard deviation in PG concentrations |  | 0 min to +105 min | 
| Coefficient of variation in PG concentrations |  | 0 min to +105 min | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Hypoglycemia, Exercise, Glucagon, Hybrid closed-loop system