NCT05601583 · Phase 1 · ACTIVE NOT RECRUITING
Care Partner-Assisted Diabetes Self-Management Through Linking Continuous Glucose Monitoring With Mobile Health: Improving Outcomes for Older Adults With Mild Cognitive Impairment
This trial tests whether pairing a continuous glucose monitor with a mobile app — and looping in a care partner — can help older adults with both Type 2 diabetes and mild cognitive impairment manage their blood sugar better. It is a small Phase 1 study, meaning researchers are in the early stage of figuring out how the approach works in practice and what features matter most, not yet testing whether it definitively improves health outcomes.
Eligibility criteria
Inclusion Criteria: Older adults must meet all of the following criteria: 1. be ≥ 65 years old; 2. have had a diagnosis of T2D for at least one year; 3. have MCI, defined as score 19-25 on the Montreal Cognitive Assessment (MoCA);60,61 4. have a care partner (e.g., spouse or adult children); 5. be willing to use CGM; 6. be fluent in English. Eligible care partners must be: 1. ≥ 18 years old; 2. living with older adults with T2D-MCI; 3. willing to be involved in patients' daily care; 4. fluent in English. Exclusion Criteria: Older adults who meet any of the following criteria will be excluded from participation in this study: 1. Refuse or are unable to provide informed consent; 2. Have serious physical illness (e.g., end-stage renal disease); 3. Presence of mental illness (e.g., schizophrenia or bipolar disorder) that would preclude participation. The care partners will be excluded if they: 1. Refuse or are unable to provide informed consent; 2. Have MCI.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-10-15