Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
NCT ID: NCT05643144
Last Updated: 2025-06-22
Study Results
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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RECRUITING
NA
62 participants
INTERVENTIONAL
2023-06-07
2026-08-17
Brief Summary
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Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.
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Detailed Description
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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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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Patient-Caregiver Dyads
Participants will wear a continuous glucose monitor
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.
Patient-Caregiver Dyads & Clinicians (first iteration)
Participants will participate in the first iteration of the user-centered design process.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Indiana University
OTHER
Responsible Party
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April Savoy
Assistant Professor
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
Countries
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Central Contacts
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Facility Contacts
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Patricia Noblet
Role: primary
Other Identifiers
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13925
Identifier Type: -
Identifier Source: org_study_id
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