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 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
NCT ID:
NCT05766735
Eligibility Criteria:
Inclusion Criteria
1. Clinical diagnosis, based on investigator assessment, of type 2 diabetes within the past 24 months
2. Age ≥30.0 and ≤80 years
3. Hemoglobin A1c = ≥6.5-≤11% (medical record value \<6 month-old is acceptable)
4. Access to smartphone throughout the study
5. Diabetes management visit with medical provider within 12 months of screening date
6. If on weight altering medications (e.g., GLP-1, GIP), on a stable dose for about four weeks
Exclusion Criteria:
1. Medications that impede weight loss within the last 3 months, per study physicians' discretion
2. Any psychotropic medication that could raise blood glucose, per study physicians' opinion
3. Conditions that preclude participating in the study (e.g., severe mental disease like manic depressive illness, severe depression, active substance abuse)
4. Conditions that preclude increasing physical activity (e.g., severe neuropathy, cardiovascular disease, COPD/emphysema, severe osteoarthritis, stroke)
5. Conditions that prevent doing the self-directed GEM program, such as inability to read English, mental health conditions that prevent engagement in treatment, such as active substance abuse, severe depression
6. Conditions that restrict diet such as severe gastroparesis, ulcers, or food allergies
7. Severe vision impairment that at PI discretion would preclude ability to read the GEM manual or see the information on the CGM or activity tracker
8. Currently undergoing treatment for cancer that in the opinion of the PI would preclude participation in the study
9. Renal impairment (for example eGFR \< 45 mL/min/1.73 meters squared; CKD-3b)
10. Currently pregnant or contemplating pregnancy within the next 14 months
11. Currently breastfeeding
12. Any condition that, in the opinion of the principal investigator, could interfere with the safe and effective completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT05766735
Study Brief:
Protocol Section:
NCT05766735