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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT02596204
Eligibility Criteria:
Inclusion Criteria:
1. Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
2. Duration of diabetes \>1 year
3. Age: 8-17 years of age, inclusive.
4. Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
5. Seen in the McNeely Diabetes Clinic within the past 6 months.
6. The family/child is testing blood glucose at least 4 times a day.
7. The family has a smart phone and service.
Exclusion Criteria:
1. The child is not using insulin for management of diabetes.
2. The child uses multiple daily injections of insulin.
3. The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
4. The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
5. Diagnosis of a mental health disorder.
6. Parent/child does not speak English as the device software is only available in English.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
17 Years
Study:
NCT02596204
Study Brief:
Protocol Section:
NCT02596204