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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02674828
Eligibility Criteria:
Inclusion Criteria:
* age 13-24 years old and live with a parent at least 4 days per week on average;
* diagnosis of type 1 diabetes \>12 months via ADA guidelines;
* mean A1c\>7.5% and \<13% in the year before study entry, and most recent A1c \>7.5% but \<13%;
* check blood sugar at least 2 times per day on average;
* access to a computer or cell phone with Internet for uploading or synching activity monitoring data and text messaging or email capabilities to communicate with study staff
* currently walk at least 1,000 steps per day, but less than 6,000 steps per day on average as assessed on \>11 days between baseline session 1 and baseline session 2
* English speaking, pass an informed consent quiz, and adequate knowledge of managing T1D
Exclusion Criteria:
* have a major psychiatric or neurocognitive disorder (e.g., severe learning impairment) or major visual impairment that would inhibit participation
* have a significant other medical condition that impacts diabetes management (e.g., eating disorder, rheumatoid arthritis, or other condition that requires steroid treatment) or a physical illness, injury or condition that may interfere with physical activity recommendations (e.g., joint, hip or back problems, uncontrolled hypertension, or BMI \> 40 kg/m2)
* plan to switch insulin delivery mode (injection to pump or vice versa) in the next 6 months, or have recently switched
* participating in another clinical trial
* fail or is unable to upload or synch the activity meter at least 4 times during the baseline period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
24 Years
Study:
NCT02674828
Study Brief:
Protocol Section:
NCT02674828