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

NCT05643144 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-05-07

No results posted yet for this study

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

Conditions

Interventions

DEVICE

Continuous Glucose Monitoring

CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH
  • Indiana University

    lead OTHER

Principal Investigators

  • April Savoy, PhD · Indiana University

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-10
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05643144 on ClinicalTrials.gov