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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes

Short name HYPOAVOID

NCTNCT05379686 (opens ClinicalTrials.gov in a new tab)Other id85256Other id2021-004993-68
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
10 participants (actual)
Sponsor
Steno Diabetes Center Copenhagen · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Denmark

Start
21 Sept 2022
Primary completion
13 May 2024
Completion
13 May 2024
First posted
18 May 2022
Last update posted
29 Aug 2025
Conditions
Type 1 Diabetes · Hypoglycemia

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2022202320242025
  1. N/A

    HYPOAVOID

    NCT05379686

    21 Sept 2022 to 13 May 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • GlucaGenDrug

Arms2

  • Experimental

    150 ug glucagon before exercise

    150 ug glucagon will be administered subcutaneously just before exercise

  • No intervention

    Control

    No glucagon will be administered before exercise

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

Secondary outcomes(12)

  1. Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period.

  2. Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention.

  3. Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

  4. Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure evaluates the difference in the percentage of time participants spend within a specified glucose target range over a defined monitoring period. The measure aims to assess improvements or changes in glycemic control resulting from the intervention under study.

  5. Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period.

  6. Difference in Nadir PG Concentration Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period.

  7. Difference in Peak PG Concentration Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period.

  8. Difference in Incremental Peak PG Concentration Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period.

  9. Difference in Mean PG Concentration Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period.

  10. Difference in PG Area Under the Curve (AUC) Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period.

  11. Difference in Standard Deviation in PG Concentrations Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period.

  12. Difference in Coefficient of Variation in PG Concentrations Between Visit B and C

    Time frame · 0 min to +105 min

    Registry description

    This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 0 min to +105 min

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

GroupValue (Percentage of time in range)
150 ug Glucagon Before Exercise100
Control100
Secondary and other outcome results(7)
Secondary outcomeCount of participants· 0 min to +105 min

Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C

GroupValue (Participants)
150 ug Glucagon Before Exercise0
Control0
Secondary outcomeMedian· 0 min to +105 min

Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C

GroupValue (minutes)
150 ug Glucagon Before ExerciseNA
ControlNA
Secondary outcomeMedian· 0 min to +105 min

Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C

GroupValue (percentage of time below range)
150 ug Glucagon Before Exercise0
Control0
Secondary outcomeMedian· 0 min to +105 min

Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C

GroupValue (percentage of time above range)
150 ug Glucagon Before Exercise0
Control0
Secondary outcomeNumber· 0 min to +105 min

Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C

GroupValue (participants)
150 ug Glucagon Before Exercise0
Control0
Secondary outcomeMedian· 0 min to +105 min

Difference in Nadir PG Concentration Between Visit B and C

GroupValue (mmol/l)
150 ug Glucagon Before Exercise5.8
Control5.8
Secondary outcomeMean· 0 min to +105 min

Difference in Peak PG Concentration Between Visit B and C

GroupValue (mmol/l)Spread
150 ug Glucagon Before Exercise9.31.8
Control7.51.4

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
150 ug Glucagon Before Exercise150 ug glucagon will be administered subcutaneously just before exercise GlucaGen: 150 ug glucagon will be administered to the participants before exercise.0 / 100 / 100 / 10
ControlNo glucagon will be administered before exercise0 / 100 / 100 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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