Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes (NCT05643144) | Clinical Trial Compass
RecruitingNot Applicable
Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
United States62 participantsStarted 2026-07-10
Plain-language 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
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.