Recruiting

Shared Decision-making

Sponsor:

Indiana University

Code:

NCT05643144

Conditions

Diabetes

Alzheimer's Disease (Incl Subtypes)

Dementia

Hypoglycemia

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Continuous Glucose Monitoring

Study Details

Brief 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

Diabetes

Alzheimer's Disease (Incl Subtypes)

Dementia

Hypoglycemia

Study ID

NCT05643144

Start date

Sep 7, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

62 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Patient-Caregiver Dyads

Participants will wear a continuous glucose monitor

Interventions

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.

Primary outcome measure

  • Feasibility- Recruitment [ Time Frame: 8 months ]
  • Feasibility- Retention [ Time Frame: 2 months ]
  • Feasibility- CGM Device Adherence [ Time Frame: 14 days ]
  • System Usability Scale [ Time Frame: 2 months ]
  • CollaboRATE Questionnaire [ Time Frame: 2 months ]
  • Number of Changes in Diabetes Management [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

April Savoy, PhD

317-278-2194asavoy@iu.edu

Nina Johnson, MA

317-274-9086kj83@regenstrief.org

Locations

Eskenazi Health

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Keywords

  • Continuous glucose monitoring
  • Shared decision-making
  • Human factors
  • Primary care

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-20.