NCT05643144 · RECRUITING
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
This trial is testing a digital tool called CGM ASSIST, which pairs a wearable blood sugar monitor with easy-to-read interactive displays. The goal is to help people with dementia and diabetes — along with their caregivers and doctors — better understand glucose data and make decisions together. This is a feasibility study, meaning researchers are checking whether the tool is practical and useful, not yet proving it works at scale.
Eligibility criteria
Patient-Caregiver Dyad Inclusion Criteria: * patient must have dual diagnosis of MCI or ADRD and diabetes (DM) * patient must have active prescriptions for DM * patient must have had at least one visit to an Eskenazi or IU Health primary care clinic within 12 months * patient must be able to provide assent and have a legally authorized representative (LAR) consent on their behalf if patient lacks capacity to consent * patient must have a caregiver aged 18 years or older who interacts daily, or almost daily, with the patient * patient and caregiver must both speak English * patient and caregiver must both reside in the community * dyad must have internet access Patient-Caregiver Dyad Exclusion Criteria: * patient has terminal illness * use of an automated insulin delivery system * patient is receiving dialysis * patient is taking ascorbic acid during monitoring period * patient has existing implanted medical devices * patient has a bleeding disorder * patient has a pre-existing arm skin lesions * patient has an allergy to medical adhesive or isopropyl alcohol * patient has plans for imaging or diathermy treatment during the study period
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 2026-08-20