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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07376850
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of T1D per ADA criteria
* Age 5.0-17.99 at the start of study
* CGM use \>70% of the time during the month prior to enrollment
* Maximum HbA1c of 86mmol/mol (10% in DCCT)
Exclusion Criteria:
* No concurrent illnesses impacting glycemia
* No treatments impacting glycemia
* Severe hypoglycemia documented in the 60 day period leading up to patient recruitment
* Current participation in any other interventional study
* Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise participant's safety
* Female subject who is pregnant or lactating or planning to become pregnant within the planned study duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT07376850
Study Brief:
Protocol Section:
NCT07376850