Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2025-12-24 @ 3:44 PM
NCT ID:
NCT05076292
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18
* T1D ≥ 2 years
* Use of insulin pump or MDI therapy for ≥ 6 months
* Current use of insulin aspart
* HbA1c ≤ 70mmol/mol (8.5%)
* Body mass index (BMI) ≤ 30 kg/m2
* Performs exercise ≥1 time per week
Exclusion Criteria:
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
* Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
* Known or suspected allergies to glucagon or related products
* History of hypersensitivity or allergic reaction to glucagon or lactose
* Allergy to the patch of the CGM devices
* Patients with pheochromocytoma, insulinoma or gastroparesis
* 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 enrollment 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
* Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05076292
Study Brief:
Protocol Section:
NCT05076292