Type 1 DiabetesHYPOAVOIDNCT05379686
Glucagon and Advanced HCL System to Prevent Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
A study testing GlucaGen in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- GlucaGen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 21 Sep 2022to 13 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Type 1 diabetes ≥ 2 years
- Use of AHCL system MiniMed 780G ≥ 4 weeks
- Use of Novorapid for ≥ 1 week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
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.
Read the 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.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- GlucaGen
- Keywords
- Type 1 Diabetes, Hypoglycemia, Exercise, Glucagon, Hybrid closed-loop system
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucaGenDrug
Also called Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01
150 ug glucagon will be administered to the participants before exercise.
| Study group | Role | What they receive |
|---|---|---|
| 150 ug glucagon before exercise | Experimental | 150 ug glucagon will be administered subcutaneously just before exercise Receives: Drug: GlucaGen |
| Control | No intervention | No glucagon will be administered before exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
Measured: 0 min to +105 min
Secondary outcomes (12)
Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C
This outcome measure assesses the frequency of hypoglycemic events experienced by participants over a specified monitoring period.
Measured: 0 min to +105 min
Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C
This outcome measure evaluates the time (in minutes) taken to reach hypoglycemia during a specified monitoring period or following a specific intervention.
Measured: 0 min to +105 min
Difference in Percentage of Time Below Target Glucose Range (PG<3.9 mmol/l) Between Visit B and C
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.
Measured: 0 min to +105 min
Difference in Percentage of Time Above Target Glucose Range (PG>10.0 mmol/l) Between Visit B and C
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.
Measured: 0 min to +105 min
Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C
This outcome measure assesses the incidence rate of hyperglycemia during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Nadir PG Concentration Between Visit B and C
This outcome measure assesses the difference in the lowest value of plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Peak PG Concentration Between Visit B and C
This outcome measure assesses the difference in peak plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Incremental Peak PG Concentration Between Visit B and C
This outcome measure assesses the difference in incremental peak of plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Mean PG Concentration Between Visit B and C
This outcome measure assesses the difference in mean plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Difference in PG Area Under the Curve (AUC) Between Visit B and C
This outcome measure assesses the difference in plasma glucose AUC during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Standard Deviation in PG Concentrations Between Visit B and C
This outcome measure assesses the difference in SD plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Difference in Coefficient of Variation in PG Concentrations Between Visit B and C
This outcome measure assesses the difference in CV in plasma glucose during a specified monitoring period.
Measured: 0 min to +105 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start21 Sep 2022
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Two-arm open-label intervention study.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sissel B Lundemose, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379686
- Sponsor's protocol ID
- 85256
- Other IDs
- 2021-004993-68
- Acronym
- HYPOAVOID
- Status last verified
- Dec 2023
- First submitted
- 12 May 2022
- Last updated
- 29 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Glucagon and Advanced Hybrid Closed-Loop System for Prevention of Exercise-Induced Hypoglycaemia in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05379686
- Acronym / sponsor ID
- HYPOAVOID / 85256
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Type 1 Diabetes, Hypoglycemia, Exercise, Glucagon, Hybrid closed-loop system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 21 Sep 2022 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Posted 29 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm open-label intervention study.
| Arm | Type | Receives |
|---|---|---|
| 150 ug glucagon before exercise | Experimental | Drug: GlucaGen150 ug glucagon will be administered subcutaneously just before exercise |
| Control | No intervention | –No glucagon will be administered before exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Type 1 diabetes ≥ 2 years
- Use of AHCL system MiniMed 780G ≥ 4 weeks
- Use of Novorapid for ≥ 1 week
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucaGenAlso: Glucagon, GlucaGen®, Novo Nordisk, ATC code H04AA01150 ug glucagon will be administered to the participants before exercise. | Drug | 150 ug glucagon before exercise |
Primary outcome
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
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.
12 secondary outcomes
Difference in Incidence Rate of Hypoglycaemic Events (PG<3.9 mmol/l) Between Visit B and C
Time frame: 0 min to +105 min
Difference in Time (Min) to Hypoglycaemia (PG<3.9 mmol/l) Between Visit B and C
Time frame: 0 min to +105 min
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
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
Difference in Incidence Rate of Hyperglycaemia (PG>10.0 mmol/l) Between Visit B and C
Time frame: 0 min to +105 min
Difference in Nadir PG Concentration Between Visit B and C
Time frame: 0 min to +105 min
Difference in Peak PG Concentration Between Visit B and C
Time frame: 0 min to +105 min
Difference in Incremental Peak PG Concentration Between Visit B and C
Time frame: 0 min to +105 min
Difference in Mean PG Concentration Between Visit B and C
Time frame: 0 min to +105 min
Difference in PG Area Under the Curve (AUC) Between Visit B and C
Time frame: 0 min to +105 min
Difference in Standard Deviation in PG Concentrations Between Visit B and C
Time frame: 0 min to +105 min
Difference in Coefficient of Variation in PG Concentrations Between Visit B and C
Time frame: 0 min to +105 min
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sissel B Lundemose, MD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucaGen in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.