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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05481034
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent
* Type 1 diabetes as defined by the World Health Organization for at least 6 months
* Age between 12 and 20 years (inclusive)
* Proficient use of continuous glucose monitoring (CGM) or flash glucose monitoring (FGM) for at least 5 days in the past
* Glycated hemoglobin A1c (HbA1c) ≤12%
* The participant is willing to wear closed-loop devices
* The participant is willing to follow study specific instructions
* Negative urine-pregnancy test in sexually active female participants of childbearing potential at screening-visit
Exclusion Criteria:
* Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
* Known or suspected allergy against insulin
* Participant is pregnant or breast feeding or planning pregnancy within next 6.5 months
* Severe visual impairment
* Severe hearing impairment
* Lack of reliable telephone facility for contact
* Concomitant participation in another trial that interferes with the normal conduct of the study and interpretation of the study results
* Participant not proficient in German
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
20 Years
Study:
NCT05481034
Study Brief:
Protocol Section:
NCT05481034