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Enhancing Shared Decision-making for Dementia and Diabetes

This study is testing a new digital tool called CGM ASSIST. This tool helps people with dementia (memory loss) and diabetes, along with their caregivers and doctors, better understand blood sugar levels. Managing diabetes can be hard for those with memory issues, and this study uses a Continuous Glucose Monitor (CGM) device to track blood sugar in real-time. CGM ASSIST then presents this information in an easy-to-read way, with medical guidelines, to help prevent dangerously low blood sugar (hypoglycemia). We are looking for 62 participants who have both diabetes and mild cognitive impairment (MCI) or Alzheimer's disease (ADRD), and who have a caregiver. The study aims to see how well we can recruit and keep participants, and how well people use the CGM device.

Study design
This is an interventional study, meaning participants will receive a specific intervention. It plans to enroll 62 participants.
What's involved
Participants will use a Continuous Glucose Monitoring (CGM) device for 14 days. They will also participate in interviews with their caregivers to discuss their experiences.
Compensation
Not stated in the trial record.
Follow-up
Participant retention will be measured for 2 months, and CGM device adherence for 14 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05643144

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

Recruiting
NAAges 65+InterventionalHealth services
Indiana University
~62 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Continuous Glucose Monitoring

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility- Recruitment
Measured over 8 months
+5 more outcomes measured

Conditions

Diabetes
Alzheimer's Disease (Incl Subtypes)
Dementia
Hypoglycemia

Explore related trials

DementiaDiabetes Mellitus

Where it's being run

1 sites across 1 states
Indiana1

Study leadership

  • April Savoy, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

April Savoy, PhD
[email protected]
317-278-2194
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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

What this trial measures

  • Feasibility- Recruitment8 months

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

  • Feasibility- Retention2 months

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

  • Feasibility- CGM Device Adherence14 days

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

  • System Usability Scale2 months

    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).

  • CollaboRATE Questionnaire2 months

    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.

  • Number of Changes in Diabetes Management12 months

    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.