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

Type 1 Diabetes Clinical Trial

— The HYPO-AVOID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379686
• Other study ID #: 85256
• Secondary ID: 2021-004993-68
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: May 13, 2024

Study information

• Verified date: December 2023
• Source: Steno Diabetes Center Copenhagen
• Contact: Sissel B Lundemmose, MD
• Phone: 0045 24846602
• Email: sissel.lundemose[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Type 1 Diabetes

Intervention

Drug:
• GlucaGen
150 ug glucagon will be administered to the participants before exercise.

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Copenhagen	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Steno Diabetes Center Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

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