The Postprandial Hypo-Avoid Study

NCTNCT07427251Other idHypoAvoid_PostPrandial

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Overview

Status: Recruiting
Phase: Phase 4
Enrollment: 18 participants (estimated)
Sponsor: Steno Diabetes Center Copenhagen · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Denmark
Start: 27 Apr 2026
Primary completion: 1 May 2027 (estimated)
Completion: 1 May 2028 (estimated)
First posted: 23 Feb 2026
Last update posted: 13 Aug 2026
Conditions: Type 1 Diabetes Mellitus

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 4
The Postprandial Hypo-Avoid Study
NCT07427251
27 Apr 2026 to est. 1 May 2028

Registry summary

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

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.

Interventions

Low-Dose GlucagonDrug
Glucose ArmDietary supplement

Arms2

Active comparator
Visit GCN
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.
Active comparator
Visit CHO
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Secondary outcomes(13)

Percent PG time in range (3.9-10.0 mmol/L) between visits GCN and CHO
Time frame · From exercise onset to +120 min
Incidence of hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO
Time frame · 0-180 min
Registry description
Binary
Time to hypoglycemia (PG <3.9 mmol/L) between visits GCN and CHO
Time frame · 0-180 min
Percent time below range (PG <3.9 mmol/L) between visit GCN and CHO
Time frame · 0-180 mins
Percent time above range (PG >10.0 mmol/L) between visits GCN and CHO
Time frame · 0-180 min
Registry description
Continuous
Incidence of hyperglycemia (PG >10.0 mmol/L) between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Binary
Nadir PG concentration between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
Peak PG concentration between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
Incremental peak PG concentration between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
Mean PG concentration between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
PG area under the curve (AUC) between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
Standard deviation of PG between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous
Coefficient of variation of PG between visits GCN and CHO
Time frame · 0-180 mins
Registry description
Continuous

Posted results

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

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

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 * 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

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