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:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT04949867
Eligibility Criteria:
Inclusion Criteria:
* Age = 13-17 years
* T1D duration ≥ 2 years
* Insulin pump therapy ≥ 1 year
* Using CGM or isCGM (Flash Libre)
* HbA1c ≤ 9.0% (75 mmol/mol)
* Using carbohydrate counting
Exclusion Criteria:
* Allergy to glucagon or lactose
* Allergy to faster insulin aspart (FiAsp)
* Pheochromocytoma
* Self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l
* Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake
* Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate contraceptive methods (intrauterine device, contraceptive pill, patch or injection)
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT04949867
Study Brief:
Protocol Section:
NCT04949867