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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT06469593
Eligibility Criteria:
Inclusion Criteria (Adults):
* Age ≥18 years
* Type 1 diabetes ≥3 years
* CGM or intermittently scanned CGM (isCGM) use ≥6 months
* Approval from the responsible health care provider (HCP) to start AID
* Specific AID system chosen ahead of screening after participant has been thoroughly informed
Inclusion Criteria (Children):
* Age 7-17 years
* Type 1 diabetes ≥6 months
* CGM or isCGM use ≥6 months
* Approval from the responsible HCP to start AID
* Specific AID system chosen ahead of screening after participant has been thoroughly informed
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 commercial or open-source AID systems prior to study participation
* Daily use of paracetamol (acetaminophen)
* Breast-feeding, pregnancy or planning to become pregnant within 4 months
* Alcohol or drug abuse
* Severe cardiac disease
* Retinopathy contraindicating HbA1c \<53 mmol/mol
* Other concomitant medical or psychological condition that, according to the investigator's assessment, makes the person unsuitable for study participation
* Lack of compliance with key study procedures at the discretion of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Years
Study:
NCT06469593
Study Brief:
Protocol Section:
NCT06469593