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

Not Applicable

Recruiting

• Conditions: Diabetes; Alzheimer's Disease (Incl Subtypes); Dementia; Hypoglycemia
• Interventions: Device: Continuous Glucose Monitoring

• Registration Number: NCT05643144
• Lead Sponsor: Indiana University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-12-01
• Study First Posted: 2022-12-08
• Study Start: 2023-06-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18
• Primary Completion: 2026-08-17
• Study Completion: 2026-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient-Caregiver Dyads	Continuous Glucose Monitoring	Participants will wear a continuous glucose monitor

Primary Outcome Measures

Name	Time	Method
Level of Situation Awareness (Aim 2)	1 day	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.
Patient and Caregiver Unmet Needs (Aim 1)	2 months	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.

Secondary Outcome Measures

Name	Time	Method
Feasibility: Retention rate of participants (Aim 1)	1 year	Retention Rate = Completed participant total/Recruited participant total
Feasibility: Percentage of patients recruited (Aim 1)	1 year	Recruitment Percentage = Participant total/Eligible population total
Feasibility: CGM data completeness (Aim 1)	2 months	Count of total days CGM worn \[CGM performs calculation\]
Hypoglycemia: Percentage of time below range (Aim 1)	2 months	Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
Mean glucose (Aim 1)	2 months	Mean = sum of glucose readings / total amount of glucose readings \[CGM performs calculation\]
Severe Hypoglycemia: Percentage of time below range (Aim 1)	2 months	Percentage = glucose readings and time \<54 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
Percentage of time in range (Aim 1)	2 months	Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
Glucose management indicator (Aim 1)	2 months	Estimated A1C automated calculation based on 14 days of CGM data \[CGM performs calculation\]
Glucose variability (Aim 1)	2 months	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) \[CGM performs calculation\]

Trial Locations

Locations (1)

Eskenazi Health; 🇺🇸 Indianapolis, Indiana, United States