NCT07427251 The Postprandial Hypo-Avoid Study
| NCT ID | NCT07427251 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Steno Diabetes Center Copenhagen |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2026-04-27 |
| Primary Completion | 2027-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 18 participants in total. It began in 2026-04-27 with a primary completion date of 2027-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Eligibility Criteria
Inclusion Criteria: * 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 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
Contact & Investigator
Kirsten Nørgaard, MD, Professor
STUDY DIRECTOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT07427251 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07427251 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07427251 currently recruiting?
Yes, NCT07427251 is actively recruiting participants. Contact the research team at emilie.lindkvist@regionh.dk for enrollment information.
Where is the NCT07427251 trial being conducted?
This trial is being conducted at Herlev, Denmark.
Who is sponsoring the NCT07427251 clinical trial?
NCT07427251 is sponsored by Steno Diabetes Center Copenhagen. The principal investigator is Kirsten Nørgaard, MD, Professor at Steno Diabetes Center Copenhagen. The trial plans to enroll 18 participants.
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