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

Study Overview
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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.

Official Title
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Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes

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

Intervention / Treatment
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* Device: Continuous Glucose Monitoring


Participation Criteria
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Eligibility Criteria
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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 patient has prior use of CGM device 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient-Caregiver Dyads<br>Participants will wear a continuous glucose monitor | Device: Continuous Glucose Monitoring<br>* CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.<br>|
| No Intervention: Patient-Caregiver Dyads & Clinicians (first iteration)<br>Participants will participate in the first iteration of the user-centered design process. | |
| No Intervention: Patient-Caregiver Dyads & Clinicians (second iteration)<br>Participants will participate in the second iteration of the user-centered design process. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Caregiver Unmet Needs (Aim 1) | Semi-structured Interviews: Baseline interview questions will be framed by validated psychometric measurements of hypoglycemia unawareness, fear of hypoglycemia, ADRD quality of life, and DM distress. Observation interviews will be conducted to elicit patients' and caregivers' perceptions about hypoglycemia and describe their specific risks (e.g., nutrition, resources, stress, finances). Debrief interviews will review CGM data with participants and ask clarifying questions to elicit descriptions of their overall experiences. | 2 months | 
| Level of Situation Awareness (Aim 2) | Contextual Inquiries: With and without examples of information displays present, we will invite participants questions related to identifying and reading glucose values (e.g., identify glycemic targets), and articulate perceived important information at specific decision points. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility: Percentage of patients recruited (Aim 1) | Recruitment Percentage = Participant total/Eligible population total | 1 year | 
| Feasibility: Retention rate of participants (Aim 1) | Retention Rate = Completed participant total/Recruited participant total | 1 year | 
| Feasibility: CGM data completeness (Aim 1) | Count of total days CGM worn [CGM performs calculation] | 2 months | 
| Hypoglycemia: Percentage of time below range (Aim 1) | Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation] | 2 months | 
| Severe Hypoglycemia: Percentage of time below range (Aim 1) | Percentage = glucose readings and time <54 mg/dL / total amount of readings and time monitored [CGM performs calculation] | 2 months | 
| Percentage of time in range (Aim 1) | Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation] | 2 months | 
| Mean glucose (Aim 1) | Mean = sum of glucose readings / total amount of glucose readings [CGM performs calculation] | 2 months | 
| Glucose management indicator (Aim 1) | Estimated A1C automated calculation based on 14 days of CGM data [CGM performs calculation] | 2 months | 
| Glucose variability (Aim 1) | Oscillations in blood glucose levels: Measurement of fluctuations of glucose or other related parameters of glucose homoeostasis over a given interval of time (i.e., within a day, between days or longer term) [CGM performs calculation] | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous glucose monitoring, Shared decision-making, Human factors, Primary care