Low-Dose Glucagon and Automated Insulin Delivery for Prevention of Spontaneous Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
New study tests glucagon to prevent low blood sugar during exercise in Type 1 Diabetes
Plain English Summary
The Postprandial Hypo-Avoid Study is a Phase 4 clinical trial sponsored by Steno Diabetes Center Copenhagen studying Type 1 Diabetes Mellitus. This study tests if a small dose of glucagon given before exercise can prevent low blood sugar (hypoglycemia) in adults with Type 1 Diabetes who use an insulin pump system. It is for adults aged 18 and older who have had Type 1 Diabetes for at least two years and have been using an automated insulin delivery system for at least three months. Participants will have two exercise sessions, one where they receive glucagon before exercising and another where they receive glucose. Blood sugar levels will be closely monitored. Current alternatives for managing exercise-induced hypoglycemia include adjusting insulin doses, consuming carbohydrates before or during exercise, or stopping exercise. The trial aims to enroll 18 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have Type 1 Diabetes for at least 2 years, and use an automated insulin delivery system for at least 3 months. You cannot join if you have allergies to lactose or glucagon, or have certain medical conditions like pheochromocytoma or gastroparesis. Women who are pregnant, breastfeeding, or planning to become pregnant must not join unless using effective contraception. Postmenopausal women or those who are sterilized are eligible. You must be able to understand study information and give your consent. The investigator will also assess if you are suitable for the study. This trial is studying Type 1 Diabetes Mellitus, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if giving a small amount of glucagon before exercise keeps blood sugar levels more stable during and after exercise, preventing them from dropping too low. The specific primary outcome measures are: 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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial aims to fill a gap in managing exercise-induced low blood sugar for people with Type 1 Diabetes using advanced insulin pump technology, potentially improving safety and quality of life. This research targets Type 1 Diabetes Mellitus, where improved treatment options are needed.
Investor Insight
This Phase 4 study, sponsored by Steno Diabetes Center Copenhagen, focuses on a specific aspect of diabetes management in a growing user base of automated insulin delivery systems, suggesting a potent This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of taking glucagon before exercise. Understand how your blood sugar will be monitored throughout the study. Be prepared for two separate exercise sessions where your blood sugar and response to treatment will be closely observed. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: CROSSOVER
- Masking: NONE
- Enrollment: 18 participants
Interventions
- DRUG: Low-Dose Glucagon — Participants will be given a low-dose of glucagon before starting the exercise session
- DIETARY_SUPPLEMENT: Glucose Arm — Participants will be given a dose of glucose before starting exercise
Primary Outcomes
- 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
- 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)
Full 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
Frequently Asked Questions
What is clinical trial NCT07427251?
NCT07427251 is a Phase 4 INTERVENTIONAL study titled "The Postprandial Hypo-Avoid Study." It is currently not yet recruiting and is sponsored by Steno Diabetes Center Copenhagen. The trial targets enrollment of 18 participants.
What conditions does NCT07427251 study?
This trial investigates treatments for Type 1 Diabetes Mellitus. The primary condition under study is Type 1 Diabetes Mellitus.
What treatments are being tested in NCT07427251?
The interventions being studied include: Low-Dose Glucagon (DRUG), Glucose Arm (DIETARY_SUPPLEMENT). Participants will be given a low-dose of glucagon before starting the exercise session
What does Phase 4 mean for NCT07427251?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT07427251?
This trial is currently "Not Yet Recruiting." It started on 2026-03-15. The estimated completion date is 2028-05-01.
Who is sponsoring NCT07427251?
NCT07427251 is sponsored by Steno Diabetes Center Copenhagen. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07427251?
The trial aims to enroll 18 participants. The trial has not yet started recruiting.
How is NCT07427251 designed?
This is a interventional study, uses randomized allocation, follows a crossover design, employs none masking.
What are the primary outcomes being measured in NCT07427251?
The primary outcome measures are: 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). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07427251?
The official record for NCT07427251 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07427251. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07427251 testing in simple terms?
This study tests if a small dose of glucagon given before exercise can prevent low blood sugar (hypoglycemia) in adults with Type 1 Diabetes who use an insulin pump system. It is for adults aged 18 and older who have had Type 1 Diabetes for at least two years and have been using an automated insulin delivery system for at least three months.
Why is this trial significant?
This trial aims to fill a gap in managing exercise-induced low blood sugar for people with Type 1 Diabetes using advanced insulin pump technology, potentially improving safety and quality of life.
What are the potential risks of participating in NCT07427251?
The most common side effects of glucagon can include nausea and vomiting. There is a small risk of allergic reactions to glucagon or lactose. Potential for temporary increases in blood sugar above the target range after glucagon administration. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07427251?
Ask your doctor about the potential benefits and risks of taking glucagon before exercise. Understand how your blood sugar will be monitored throughout the study. Be prepared for two separate exercise sessions where your blood sugar and response to treatment will be closely observed. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07427251 signal from an investment perspective?
This Phase 4 study, sponsored by Steno Diabetes Center Copenhagen, focuses on a specific aspect of diabetes management in a growing user base of automated insulin delivery systems, suggesting a potent This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will have two exercise sessions, one where they receive glucagon before exercising and another where they receive glucose. Blood sugar levels will be closely monitored. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Type 1 Diabetes Mellitus Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.