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

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.

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Type 1 Diabetes
• Intervention / Treatment: Drug: GlucaGen

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.

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sissel B Lundemmose, MD; Phone Number: 0045 24846602; Email: sissel.lundemose@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Steno Diabetes Center Copenhagen
    • Contact: Sissel B Lundemose, MD; Phone Number: +4524846602; Email: sissel.lundemose@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 150 ug glucagon before exercise; 150 ug glucagon will be administered subcutaneously just before exercise	Drug: GlucaGen; 150 ug glucagon will be administered to the participants before exercise.; Other Names: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01
No Intervention: Control; No glucagon will be administered before exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Difference in incidence rate of hypoglycaemic events (PG<3.9 mmol/l) between visit B and C	0 min to +105 min
Difference in time (min) to hypoglycaemia (PG<3.9 mmol/l) between visit B and C	0 min to +105 min
Difference in percentage of time below target glucose range (PG<3.9 mmol/l) between visit B and C	0 min to +105 min
Difference in percentage of time above target glucose range (PG>10.0 mmol/l) between visit B and C	0 min to +105 min
Difference in incidence rate of hyperglycaemia (PG>10.0 mmol/l) between visit B and C	0 min to +105 min
Difference in nadir PG concentration between visit B and C	0 min to +105 min
Difference in peak PG concentration between visit B and C	0 min to +105 min
Difference in incremental peak PG concentration between visit B and C	0 min to +105 min
Difference in mean PG concentration between visit B and C	0 min to +105 min
Difference in PG Area Under the Curve (AUC) between visit B and C	0 min to +105 min
Difference in standard deviation in PG concentrations between visit B and C	0 min to +105 min
Difference in Coefficient of variation in PG concentrations between visit B and C	0 min to +105 min

Collaborators and Investigators

• Sponsor: Steno Diabetes Center Copenhagen
• Investigators: Principal Investigator: Sissel B Lundemose, MD, Steno Diabetes Center Copenhagen

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2022
• Primary Completion (Estimated): May 13, 2024
• Study Completion (Estimated): May 13, 2024

Study Registration Dates

• First Submitted: May 12, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Hypoglycemia; Exercise; Type 1 Diabetes; Glucagon; Hybrid closed-loop system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucagon
• Other Study ID Numbers: 85256; 2021-004993-68 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No