The Postprandial Hypo-Avoid Study

NCT07427251 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: HypoAvoid_PostPrandial
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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

  From exercise initiation until two hours following exercise

Secondary Outcomes (13)

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

  From exercise onset to +120 min

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

  0-180 min

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

  0-180 min

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

  0-180 mins

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

  0-180 min

Study Arms (2)

Visit GCN

ACTIVE COMPARATOR

Plasma 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.

Drug: Low-Dose Glucagon

Visit CHO

ACTIVE COMPARATOR

Plasma 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.

Dietary Supplement: Glucose Arm

Interventions

Low-Dose Glucagon DRUG

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

Visit GCN

Glucose Arm DIETARY_SUPPLEMENT

Participants will be given a dose of glucose before starting exercise

Visit CHO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Glucagon

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Proglucagon; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Kirsten Nørgaard, MD, Professor

  Steno Diabetes Center Copenhagen

  STUDY DIRECTOR

Central Study Contacts

Emilie Lindkvist, MD, PhD Candidate

CONTACT

+45 21563054; emilie.lindkvist@regionh.dk

Sissel Lundemose, MD, PhD

CONTACT

+4523742764; sissel.lundemose@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share