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Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

RECRUITINGN/ASponsored by Indiana University
Actively Recruiting
PhaseN/A
SponsorIndiana University
Started2026-07-10
Est. completion2027-06-30
Eligibility
Age65 Years+
Healthy vol.Accepted
Locations1 site

Summary

The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors. Managing diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings. The study aims to: * Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it. * Improve Teamwork: Encourage "shared decision-making," where patients, caregivers, and doctors work together to make health choices. * Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives. * Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes. By using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team. Participants will: * Answer a survey about how they manage their diabetes * Learn how to use a Continuous Glucose Monitor and wear it for 14 days * Answer 3 brief telephone surveys during these 14 days * Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report

Eligibility

Age: 65 Years+Healthy volunteers accepted
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

Conditions5

Alzheimer's DiseaseAlzheimer's Disease (Incl Subtypes)DementiaDiabetesHypoglycemia

Locations1 site

Eskenazi Health
Patricia Noblet

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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