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 (Aims 1 + 2):
* 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 (Aims 1 +2):
* 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
Clinician Participant Inclusion Criteria (Aim 2):
* primary care physicians
* nurses
* pharmacists
* nutritionists
* psychologists
* medical residents
Clinician Participant Exclusion Criteria (Aim 2):
* only treats patients younger than 65 years
* does not manage patients' DM

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 2026-05-07

View full record on ClinicalTrials.gov

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