The HYPO-AVOID STUDY: Low-dose Glucagon and Advanced Insulin pump for Prevention of Exercise-Induced Low Blood Glucose Levels in People with Type 1 Diabetes

Phase 1

• Conditions: Type 1 Diabetes; MedDRA version: 21.1Level: PTClassification code 10067584Term: Type 1 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-004993-68-DK
• Lead Sponsor: Steno Diabetes Center Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-19
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

•Age = 18 years
•Type 1 diabetes = 2 years
•Using the AHCL system MiniMed 780G = 4 weeks
•Novorapid use =1 week

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 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the effect of low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise (visit B) versus a control trial without glucagon (visit C) on glucose responses during and after exercise in individuals with AHCL-treated T1D.;Secondary Objective: Not applicable ;Primary end point(s): 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 (0 min to +105min) between visits B and C. <br>;Timepoint(s) of evaluation of this end point: From 105 min post-intervention

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The Difference between visit B and C will be compared for the following:<br>•Incidence rate of hypoglycaemic events (PG<3.9 mmol/l) (0 min to +105min)<br>•Time (min) to hypoglycaemia (PG<3.9 mmol/l) (0 min to +105min) <br>•Percentage of time below target glucose range (PG<3.9 mmol/l) (0 min to +105min) <br>•Percentage of time above target glucose range (PG>10.0 mmol/l) (0 min to +105min)<br>•Incidence rate of hyperglycaemia (PG>10.0 mmol/l) (0 min to +105min)<br>•Nadir PG concentration (0 min to +105min)<br>•Peak PG concentration (0 min to +105min) <br>•Incremental peak PG concentration (0 min to +105min) <br>•Mean PG concentration (0 min to +105min)<br>•PG Area Under the Curve (AUC) (0 min to +105min)<br>•Standard deviation in PG concentrations (0 min to +105min)<br>•Coefficient of variation in PG concentrations (0 min to +105min)<br>;Timepoint(s) of evaluation of this end point: From 105 min post-intervention