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

NCT05643144 | Recruiting FDA Device

• 2 other identifiers: 139251K01AG076971
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Continuous glucose monitoring; Shared decision-making; Human factors; Primary care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Feasibility: Percentage of patients recruited (Aim 1)

  1 year

• Feasibility: Retention rate of participants (Aim 1)

  1 year

• Feasibility: CGM data completeness (Aim 1)

  2 months

• Hypoglycemia: Percentage of time below range (Aim 1)

  2 months

• Severe Hypoglycemia: Percentage of time below range (Aim 1)

  2 months

Study Arms (3)

Patient-Caregiver Dyads

EXPERIMENTAL

Participants will wear a continuous glucose monitor

Device: Continuous Glucose Monitoring

Patient-Caregiver Dyads & Clinicians (first iteration)

NO INTERVENTION

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

Patient-Caregiver Dyads & Clinicians (second iteration)

NO INTERVENTION

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

Interventions

Continuous Glucose Monitoring DEVICE

CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Patient-Caregiver Dyads

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Alzheimer Disease; Dementia; Hypoglycemia

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• April Savoy, PhD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

April Savoy, PhD

CONTACT

317-278-2194; asavoy@iu.edu

Kelli Norton, BS

CONTACT

317-274-9304; keltate@regenstrief.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: December 8, 2022
• Study Start: June 7, 2023
• Primary Completion (Estimated): August 17, 2026
• Study Completion (Estimated): August 17, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)