Post-meal glucagon before exercise to keep glucose from dropping in type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, non-blinded, two-period crossover trial involving 18 adults with type 1 diabetes who use an automated insulin delivery system. Each participant completes two experimental visits in random order, separated by at least seven days, comparing low-dose glucagon versus carbohydrate300 mg intake before a standardized bout of moderate-intensity exercise about 90 minutes after a meal. Primary outcome is the difference in the change in plasma glucose from exercise start to its nadir during exercise and over the subsequent 2 hours between the glucagon and carbohydrate strategies. The study activates the AID system's higher target during the exercise window. Eligibility includes adults with type 1 diabetes for at least 2 years, using an AID for ≥3 months, and proficient in carbohydrate counting; several medical exclusions apply."

Why it matters

Who can join: the full rules

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

Where it's running

• Steno Diabetes Center Copenhagen
  Herlev, Denmark Recruiting

Study contacts

• Study coordinator: Emilie Lindkvist, MD, PhD Candidate
• Email: emilie.lindkvist@regionh.dk
• Phone: +45 21563054

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

• Preventing device-related skin rashes in kids with type 1 diabetes using hydrocolloid vs silicone patches

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• Near-sensor insulin delivery with CGM in people with type 1 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.