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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT04516694
Eligibility Criteria:
Inclusion Criteria:
* \>12 and ≤18 years old
* Diagnosed with type 1 diabetes ≥12 months
* Speaks English fluently
* Cognitively able to participate in incentive program and complete surveys.
* Have access to a mobile phone to receive goal-obtainment and incentive updates
* Receives diabetes-related clinical care from Seattle Children's Hospital Diabetes Clinic
* Have the ability to upload medical data remotely from home per usual care processes employed by Seattle Children's Hospital Diabetes Clinics
Exclusion Criteria:
* Patient is already participating in another research study to improve diabetes self-care and/or glycemic control
* Baseline daily average glucose checks are greater than 4 checks per day OR baseline daily CGM active wear is greater than 70% of the time AND baseline average insulin bolus score is greater than 3 times a day OR they do not use an insulin pump (or are unwilling to use a smart insulin pen)
* Patient refusal to participate (any age), or caregiver refusal to participate for patients less than 18 years of age
* Cognitively or physically unable to participate
* Patient is unable to speak in the English language
* Patient is unable to read in the English language
* Patient is a ward of the state
* Patient has severe comorbidities including other major chronic health conditions that significantly impact daily management demands or health outcomes
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT04516694
Study Brief:
Protocol Section:
NCT04516694