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 @ 3:54 AM
Ignite Modification Date:
2025-12-25 @ 3:54 AM
NCT ID:
NCT07116902
Eligibility Criteria:
Inclusion Criteria:
* Age 10- 21 years
* Diagnosis of T2D based on clinical diagnosis or ICD 9 and 10 codes
* Duration of T2D ≥ 3 months
* HbA1C ≥ 7% which is the target HbA1C recommended by the American Diabetes Association
* Stable medication regimen (No medication changes and no change in basal insulin dose by more than 20% in the 2 weeks prior to enrollment)
* Ability to wear CGM for a total of 6 weeks while in the study.
* English or Spanish speakers.
* Willing to abide by recommendations and study procedures.
* Willing and able to sign the Informed Consent Form (ICF) and/or has a parent or guardian willing and able to sign the ICF.
Exclusion Criteria:
* Pancreatic autoantibody positivity (GAD-65, insulin, IA-2, ICA 512, ZnT8).
* Plan for undergoing bariatric surgery during the study period
* Anticipated use of systemic glucocorticoids during the study period
* Unable to stop taking more than 500mg/day of Vitamin C during the study period as this may affect the sensor readings.
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
* Presence of a condition or abnormality that in the opinion of the Investigator would cause repeated hospitalizations or significant changes in medications.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
21 Years
Study:
NCT07116902
Study Brief:
Protocol Section:
NCT07116902