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

NCT05643144 | Recruiting FDA Device

• 2 other identifiers: 139251K01AG076971
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Diabetes; Alzheimer's Disease (Incl Subtypes); Dementia; Hypoglycemia

Keywords

Continuous glucose monitoring; Shared decision-making; Human factors; Primary care

Outcome Measures

Primary Outcomes (6)

• Feasibility- Recruitment

  Total number of participants enrolled divided by the total participants screened as eligible.

  8 months

• Feasibility- Retention

  Total number of participants who completed the study divided by the total number of participants enrolled in the study.

  2 months

• Feasibility- CGM Device Adherence

  This measures data completeness. Total number of days CGM worn and active divided by the total number of days in the observation period.

  14 days

• System Usability Scale

  The System Usability Scale (SUS) is a 10-item validated questionnaire used to evaluate the usability of the CGM ASSIST interactive information display. Participants rate each item on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). To calculate the final SUS score, the response for each odd-numbered item is reduced by 1, and the response for each even-numbered item is subtracted from 5. These adjusted scores are then summed and multiplied by 2.5. The total score ranges from 0 to 100. A higher score indicates better usability (e.g., a score above 68 is generally considered above average).

  2 months

• CollaboRATE Questionnaire

  The CollaboRATE questionnaire is a 3-item validated patient-reported measure used to assess the level of shared decision-making during clinical encounters. The three items focus on how much effort was made: 1) to help the participant understand their health issues, 2) to listen to what matters most to the participant, and 3) to include the participant's preferences in the choice of next steps. Each item is scored on a 5-point Likert scale ranging from 1 (No effort was made) to 5 (Every effort was made). For each participant, a total score is calculated by summing the scores of the three items. The total score ranges from 3 to 15. A higher score indicates a higher perceived level of shared decision-making.

  2 months

• Number of Changes in Diabetes Management

  This measure tracks the total number of management changes made to a participant's diabetes care plan based on medical record review. A "change" is defined as any of the following: 1) Initiation of new medications or technology, 2) New referrals to specialists or community services, 3) Discontinuation of existing medications, and 4) Modification (increase or decrease) of current medication dosages.

  12 months

Secondary Outcomes (5)

• Hypoglycemia - Time Below Range (TBR)

  14 days

• Glucose Level - Time In Range (TIR)

  14 days

• Glucose Management Indicator (GMI)

  14 days

• Glucose Variability (%GV)

  14 days

• Mean Glucose Level

  14 days

Study Arms (1)

Patient-Caregiver Dyads

EXPERIMENTAL

Participants will wear a continuous glucose monitor

Device: Continuous Glucose Monitoring

Interventions

Continuous Glucose Monitoring 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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Dementia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• April Savoy, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Savoy, PhD

CONTACT

317-278-2194; asavoy@iu.edu

Nina Johnson, MA

CONTACT

317-274-9086; kj83@regenstrief.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 8, 2022
• Study Start: September 7, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)