No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
65 and older
Sex
Any
Study type
Interventional
Purpose
Health Services Research
Participants needed
62 (estimated)
Sponsor
Indiana University · Other
Who this trial is looking for
This trial is looking for patients with both dementia and diabetes who want to learn better ways to manage their condition. Participants will use a device that monitors their blood sugar for 14 days and answer some questions about their diabetes management.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with diabetes.
I have been diagnosed with mild cognitive impairment or Alzheimer's disease.
I have an active prescription for diabetes treatment.
I have visited a primary care clinic in the last year.
I can agree to participate, or have someone legal to agree for me.
I have a caregiver who helps me daily.
We both speak English.
We both have internet access.
You may not be able to join if
I have a terminal illness.
I use an automated insulin delivery system.
I am receiving dialysis.
I take ascorbic acid during the study.
I have any implanted medical devices.
I have a bleeding disorder.
I have skin lesions on my arm.
I am allergic to medical adhesive or isopropyl alcohol.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 bl…
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
Trial Locations
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Eligibility Criteria
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 provid…
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
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