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 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT05268705
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Type 1 diabetes ≥ 5 years
* Insulin pump use ≥ 1 year
* Use of intermittently scanned continuous glucose monitoring (isCGM) or continuous glucose monitoring (CGM) ≥ 3 months
* HbA1c ≤ 69 mmol/mol (8.5%)
* Self-reported hypoglycemia awareness
* Exercising at least 30 minutes at moderate or vigorous intensity two times per week.
Exclusion Criteria:
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
* Use of a hybrid closed-loop system
* Females who are pregnant, breast-feeding or intend to become pregnant during the study period
* Ischemic heart disease
* Severe asthma
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05268705
Study Brief:
Protocol Section:
NCT05268705