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

Sponsor

Steno Diabetes Center Copenhagen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05379686

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary aim of the study is to compare the glucose response to low-dose glucagon (single 150 µg dose) administered immediately before aerobic exercise versus the glucose response to oral glucose intake (0.75 g/kg body weight) during exercise in individuals with AHCL-treated T1D.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes Hypoglycemia	Drug: GlucaGen	N/A

Detailed Description

The study consists of a screening visit (visit A) and an additional study visit (visit B). 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. The results from this study will be compared to the intervention of carbohydrates during exercise, a visit conducted in an other ongoing study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

One-arm open-label intervention study.One-arm open-label intervention study.

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Completed at least visit 3 in the SMART-study
Using the AHCL system MiniMed 780G

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