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Type 1 Diabetes MellitusPhase 4NCT07427251

The Postprandial Hypo-Avoid Study

A Phase 4 study testing Low-Dose Glucagon and Glucose Arm in people with Type 1 Diabetes Mellitus, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Low-Dose Glucagon and Glucose Arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteDenmark
Study dates
27 Apr 2026to 1 May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

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
  • Using an automated insulin delivery system for ≥ 3 months
  • NovoRapid or Fiasp use ≥1 week
  • Proficiency in carbohydrate counting

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. Contact the study team or a site near you to ask about taking part.

Emilie Lindkvist, MD, PhD Candidate contact

+45 21563054

emilie.lindkvist@regionh.dk

Sissel Lundemose, MD, PhD contact

+4523742764

sissel.lundemose@regionh.dk

Denmark1 site, 1 recruiting

  • Steno Diabetes Center Copenhagen

    Herlev

    Recruiting

Other trials in Denmark

About this study

Official title: Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes

The objective of the study is to evaluate whether pre-exercise administration of low-dose subcutaneous glucagon prevents or attenuates exercise-induced declines in plasma glucose concentration during and after moderate-intensity continuous exercise (MICE) performed approximately 90 minutes after a meal in adults with type 1 diabetes using an automated insulin delivery (AID) system.

The primary endpoint is the difference in the change in plasma glucose (PG) from exercise initiation to the nadir during exercise and through the 2-hour post-exercise period between the glucagon (GCN) and carbohydrate (CHO) visits.

Read the detailed description

This is a randomized, non-blinded, two-period crossover study including 18 adults with type 1 diabetes using an EU-approved automated insulin delivery (AID) system. Each participant will attend one screening visit followed by two experimental visits performed in random order, separated by at least seven days.

Eligible participants are adults (≥18 years) with type 1 diabetes for at least 2 years, using an automated insulin delivery system for ≥3 months, treated with NovoRapid or Fiasp for at least 1 week prior to enrollment, and proficient in carbohydrate counting.

At each experimental visit, participants will perform a standardized bout of MICE approximately 90 minutes after a meal. On one visit, a low-dose glucagon injection will be administered immediately before exercise; on the other, 20 g oral glucose tablets will be consumed. Right before exercise, the AID system's higher glucose target/exercise mode will be activated and will remain active until 15 minutes after exercise.

Being tested
Low-Dose Glucagon, Glucose Arm
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-Dose GlucagonDrug

    Participants will be given a low-dose of glucagon before starting the exercise session

  • Glucose ArmDietary supplement

    Participants will be given a dose of glucose before starting exercise

Study groups in NCT07427251
Study groupRoleWhat they receive
Visit GCNActive comparatorPlasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given low-dose glucagon to prevent hypoglycemia.
Receives: Drug: Low-Dose Glucagon
Visit CHOActive comparatorPlasma and sensor glucose are monitored before, during, and after a bout of moderate-intensity exercise shortly after consumption of a meal. Before exercise initiation, participants will be given a dose of glucose to prevent hypoglycemia.
Receives: Dietary Supplement: Glucose Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period between visit GCN and CHO

    Measured: From exercise initiation until two hours following exercise

Secondary outcomes (13)

  1. Percent PG time in range (3.9-10.0 mmol/L) between visits GCN and CHO

    Measured: From exercise onset to +120 min

  2. Incidence of hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO

    Binary

    Measured: 0-180 min

  3. Time to hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO

    Measured: 0-180 min

  4. Percent time below range (PG <3.9 mmol/L) between visit GCN and CHO

    Measured: 0-180 mins

  5. Percent time above range (PG >10.0 mmol/L) between visits GCN and CHO

    Continuous

    Measured: 0-180 min

  6. Incidence of hyperglycemia (PG >10.0 mmol/L) between visits GCN and CHO

    Binary

    Measured: 0-180 mins

  7. Nadir PG concentration between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  8. Peak PG concentration between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  9. Incremental peak PG concentration between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  10. Mean PG concentration between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  11. PG area under the curve (AUC) between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  12. Standard deviation of PG between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

  13. Coefficient of variation of PG between visits GCN and CHO

    Continuous

    Measured: 0-180 mins

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2026
  2. Study start27 Apr 2026
  3. Primary completion1 May 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

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 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07427251
Sponsor's protocol ID
HypoAvoid_PostPrandial
Status last verified
Feb 2026
First submitted
16 Feb 2026
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Low-Dose Glucagon and Glucose Arm in people with Type 1 Diabetes Mellitus, 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 5 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: looking for participants now, as of the sponsor's last update on 13 Aug 2026. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie Lindkvist, MD, PhD Candidate (+45 21563054, emilie.lindkvist@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in plasma glucose (PG) from exercise initiation to the nadir during exercise and throughout the 2-hour post-exercise period between visit GCN and CHO (time frame: From exercise initiation until two hours following exercise). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07427251.

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 13 Aug 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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