NCT05643144

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Continuous Glucose Monitoring	CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Timeline

• Start date: 2023-06-07
• Primary completion: 2026-08-17
• Completion: 2026-08-17
• First posted: 2022-12-08
• Last updated: 2025-06-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study