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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT05643144
Status
Recruiting
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Conditions

  • Alzheimer's Disease (Incl Subtypes)
  • Dementia
  • Diabetes
  • Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous Glucose Monitoring — DEVICE
    CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Study Details

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

Key Dates

Start date
Jul 10, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
62 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Patient-Caregiver Dyads
    Participants will wear a continuous glucose monitor
  • No Intervention: Patient-Caregiver Dyads & Clinicians (first iteration)
    Participants will participate in the first iteration of the user-centered design process.
  • No Intervention: Patient-Caregiver Dyads & Clinicians (second iteration)
    Participants will participate in the second iteration of the user-centered design process.

Primary Outcome Measure

Feasibility- Recruitment [ Time Frame: 8 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eskenazi HealthIndianapolisIndiana46202
Patricia Noblet

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By research site
Eskenazi Health· Indianapolis, IN

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