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New digital tool aims to simplify diabetes care for Alzheimer's patients

NCT ID NCT05643144

Knowledge-focused Sponsor: Indiana University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This study tests a digital tool called CGM ASSIST that combines a continuous glucose monitor with easy-to-read displays. The goal is to help people with Alzheimer's or dementia and diabetes, along with their caregivers, better understand blood sugar levels and make informed decisions with their doctors. Sixty-two patient-caregiver pairs will wear the monitor for 14 days and complete surveys to see if the tool is useful and easy to use.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Continuous Glucose Monitor (CGM) and interactive information display (CGM ASSIST)
What this could lead to
If successful, this could lead to a practical tool that helps families and doctors better manage diabetes in people with memory loss, reducing dangerous low blood sugar events.
What could go wrong
This is a small, early feasibility study with only 62 participants, so results may not apply to everyone. The tool may not be easy to use or may not improve health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 62 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia diabetes mellitus hypoglycemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease (incl subtypes) Dementia Diabetes Hypoglycemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Eskenazi Health

    RECRUITING

    Indianapolis, Indiana, 46202, United States

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