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 @ 7:25 PM
Ignite Modification Date:
2025-12-24 @ 7:25 PM
NCT ID:
NCT06028503
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed diabetes (self-reported) and with an HbA1c ≥ 6.0 (using point-of-care device)
2. at least 18 years of age or older
3. able to speak English
4. able to provide informed consent and participate in the study
5. reliable access to a personal smartphone device 6) zip code is associated with a rural area.
Exclusion Criteria:
1. Reported suicidal ideation at the initial visit
2. has evidence of acute psychosis that precludes informed consent
3. appears to be cognitively impaired to the extent that precludes informed consent
4. uses a heavy amount of alcohol or other substances
5. is deemed by the multidisciplinary study team has too medically complex for a more conservative treatment approach
6. has a pacemaker or other implanted electrical medical device
7. Pregnant (management of diabetes while pregnant may require additional medical oversight).
8. Under 18 years old (protocol was validated for adults)
9. Non-English-speaking individuals (protocol has not been translated and validated in other languages)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06028503
Study Brief:
Protocol Section:
NCT06028503