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

Indiana University

Status: Enrolling

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

Treatments: Device: Continuous Glucose Monitoring

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05643144

1K01AG076971 (U.S. NIH Grant/Contract)

13925

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 62 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patient-Caregiver Dyad Inclusion Criteria (Aims 1 + 2):

• 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 (Aims 1 +2):

• 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

Clinician Participant Inclusion Criteria (Aim 2):

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

Clinician Participant Exclusion Criteria (Aim 2):

• only treats patients younger than 65 years
• does not manage patients' DM

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 3 patient groups

Patient-Caregiver Dyads

Experimental group

Description:

Participants will wear a continuous glucose monitor

Treatment:

Device: Continuous Glucose Monitoring

Patient-Caregiver Dyads & Clinicians (first iteration)

No Intervention group

Description:

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

Patient-Caregiver Dyads & Clinicians (second iteration)

No Intervention group

Description:

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