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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT04765358
Eligibility Criteria:
Inclusion Criteria:
1. Age \>18 years old
2. Diagnosis of type 1 diabetes or type 2 diabetes and using insulin therapy (at least 3 injections of insulin per day or insulin pump that is compatible with Tidepool software); Multiple daily injection (MDI) users must be willing to use a device provided by the study that records the injection dosages and/or enter insulin dosing information through an app
3. See a healthcare provider at least once a year
4. Resident of United States and plan to reside in the U.S. for the duration of the study (This requirement is due to virtual clinic license requirements and U.S. use restrictions for some study software and devices. Not all U.S. states may be eligible for inclusion due to virtual clinic license status.)
5. Use either an Android or iOS smartphone that is compatible with app requirements that are needed for the study
6. Access to a compatible computer with internet
7. Understand written and spoken English
8. Willing and able to follow the study procedures as instructed
Exclusion Criteria:
1. Current use of a closed loop system where an insulin pump and CGM share information and insulin dose is automatically adjusted based on glucose reading
2. Current CGM use where Time in Range is ≥60.0% or Time \<54% is ≤1.0%.
3. Current use of any off-label glucose-lowering medications for diabetes type (Example: T1D use of non-insulin, anti-diabetic medications including SGLT2 inhibitors). Use of such medications during the study will also be prohibited.
4. Females who are pregnant, intending to become pregnant, or breastfeeding during the study
5. Current renal dialysis or plan to begin renal dialysis during the study
6. Active cancer treatment
7. Extreme visual or hearing impairment that would impair ability to use real-time CGM
8. Known adhesive allergy/prior skin reaction or skin reaction identified during the blinded CGM use phase that would preclude continued CGM use
9. Participation in a different diabetes management study during the study
10. Planned relocation to a state other than current state of residence during the study if virtual clinic is not licensed in the new state. Individuals working routinely in a state other than current state of residence in the next six months are also ineligible if the virtual clinic is not licensed in that state.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04765358
Study Brief:
Protocol Section:
NCT04765358