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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 (The HYPO-AVOID)

Primary Purpose

Type 1 Diabetes, Hypoglycemia

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
GlucaGen
Sponsored by
Steno Diabetes Center Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Hypoglycemia, Exercise, Glucagon, Hybrid closed-loop system

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Steno Diabetes Center CopenhagenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

150 ug glucagon before exercise

Arm Description

150 ug glucagon will be administered subcutaneously just before exercise

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
May 12, 2022
Last Updated
March 13, 2023
Sponsor
Steno Diabetes Center Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT05379686
Brief Title
Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Steno Diabetes Center Copenhagen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Hypoglycemia
Keywords
Type 1 Diabetes, Hypoglycemia, Exercise, Glucagon, Hybrid closed-loop system

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
One-arm open-label intervention study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
150 ug glucagon before exercise
Arm Type
Experimental
Arm Description
150 ug glucagon will be administered subcutaneously just before exercise
Intervention Type
Drug
Intervention Name(s)
GlucaGen
Other Intervention Name(s)
Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01
Intervention Description
150 ug glucagon will be administered to the participants before exercise.
Primary Outcome Measure Information:
Title
Percentage of time in target glucose range (PG: 3.9 - 10.0 mmol/l) during and for 1-hour after dynamic physical exercise
Time Frame
0 min to +105 min
Secondary Outcome Measure Information:
Title
Incidence rate of hypoglycaemic events (PG<3.9 mmol/l)
Time Frame
0 min to +105 min
Title
Time (min) to hypoglycaemia (PG<3.9 mmol/l)
Time Frame
0 min to +105 min
Title
Percentage of time below target glucose range (PG<3.9 mmol/l)
Time Frame
0 min to +105 min
Title
Percentage of time above target glucose range (PG>10.0 mmol/l)
Time Frame
0 min to +105 min
Title
Incidence rate of hyperglycaemia (PG>10.0 mmol/l)
Time Frame
0 min to +105 min
Title
Nadir PG concentration
Time Frame
0 min to +105 min
Title
Peak PG concentration
Time Frame
0 min to +105 min
Title
Incremental peak PG concentration
Time Frame
0 min to +105 min
Title
Mean PG concentration
Time Frame
0 min to +105 min
Title
PG Area Under the Curve (AUC)
Time Frame
0 min to +105 min
Title
Standard deviation in PG concentrations
Time Frame
0 min to +105 min
Title
Coefficient of variation in PG concentrations
Time Frame
0 min to +105 min

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sissel B Lundemmose, MD
Phone
0045 24846602
Email
sissel.lundemose@regionh.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sissel B Lundemose, MD
Organizational Affiliation
Steno Diabetes Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Steno Diabetes Center Copenhagen
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sissel B Lundemose, MD
Phone
+4524846602
Email
sissel.lundemose@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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