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:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2025-12-24 @ 2:50 PM
NCT ID:
NCT01472159
Eligibility Criteria:
Inclusion Criteria:
* Age 8-17 years
* Planning to be living at home for 2 years
* Type 1 diabetes of at least 1 year duration
* Daily insulin dose ≥0.5 units/kg
* A1c ≥6.5% and ≤10.0%
* Insulin therapy with continuous subcutaneous insulin infusion (CSII) or multiple daily injections (≥3 injections/day)
* Blood glucose (BG) monitoring frequency ≥4 times/day
* Agreement to wear a CGM device
* Fluency in English for child and parent/guardian
* Stable living situation for ≥6 months (e.g., no Department of Youth Services Involvement)
* Joslin Clinic attendance: At least one Joslin Clinic visit in last year AND Anticipated care at Joslin Clinic for duration of study
Exclusion Criteria:
* Consistent CGM use, defined as 6+ days/week during the previous 6 months
* History of severe, life-threatening skin reactions to the adhesive used with the CGM device
* Pregnancy in the youth participant or intention to become pregnant within the next 2 years
* Significant developmental or cognitive disorder in the youth or parent/guardian that would prevent full participation in a family-based, behavioral intervention or implementation of CGM
* Inpatient psychiatric admission within the previous 6 months
* Participation in another intervention study during the previous 3 months
* Intent to enroll in another intervention study during the study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT01472159
Study Brief:
Protocol Section:
NCT01472159