NCT05643144Recruiting

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

Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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

Status (registry): Recruiting
Study type: Interventional
Enrollment: 62 (estimated)
First submitted: 11 Nov 2022
Start date: 29 Sept 2026
Primary completion date: 30 Jun 2027
Lead sponsor: Indiana University
Diseases: Alzheimer disease
NCT number: NCT05643144

What you commit to

Study type: Interventional
Planned participants: 62
From 29 Sept 2026 to the primary completion date, 30 Jun 2027
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

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

Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Eskenazi Health Coordinator of this site? Confirm its status	Indianapolis	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.