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

NCT ID: NCT05643144

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-07

Study Completion Date

2026-08-17

Brief Summary

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Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device.

Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

Detailed Description

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Aim 1: Patient-caregiver dyads will participant in a semi-structured interview to establish a baseline. The dyad will receive standard diabetes educational materials along with a CGM training and instructions for device use. Patients will then wear the CGM device for 14 days. Three follow-up interviews will take place during the 14-day scanning period, as well as a debrief interview following the scanning period for assessment and technical support.

Aim 2: Patient-caregiver dyads and clinicians will participate in a user-centered design session to guide the design of interactive information displays to improve the interpretability of CGM data.

Conditions

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Diabetes Alzheimer's Disease (Incl Subtypes) Dementia Hypoglycemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient-Caregiver Dyads

Participants will wear a continuous glucose monitor

Group Type EXPERIMENTAL

Continuous Glucose Monitoring

Intervention Type DEVICE

CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Patient-Caregiver Dyads & Clinicians (first iteration)

Participants will participate in the first iteration of the user-centered design process.

Group Type NO_INTERVENTION

No interventions assigned to this group

Patient-Caregiver Dyads & Clinicians (second iteration)

Participants will participate in the second iteration of the user-centered design process.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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


* primary care physicians
* nurses
* pharmacists
* nutritionists
* psychologists
* medical residents

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


* only treats patients younger than 65 years
* does not manage patients' DM
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Indiana University

OTHER

Sponsor Role lead

Responsible Party

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April Savoy

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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April Savoy, PhD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

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Eskenazi Health

Indianapolis, Indiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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April Savoy, PhD

Role: CONTACT

317-278-2194

Kelli Norton, BS

Role: CONTACT

317-274-9304

Facility Contacts

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Patricia Noblet

Role: primary

Other Identifiers

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1K01AG076971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13925

Identifier Type: -

Identifier Source: org_study_id

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