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

The goal of this study is to test CGM ASSIST. This is a digital tool that uses an interactive information display-an easy-to-read screen designed to help people with dementia (or memory loss) and diabetes, as well as their caregivers and doctors.

Managing diabetes is often difficult for people with memory issues. This study uses a Continuous Glucose Monitor (CGM), which is a device that tracks blood sugar levels in real-time. CGM ASSIST adds a new way to see this data through interactive displays. These displays show clear information and medical guidelines to help patients and caregivers make sense of the glucose readings.

The study aims to:

• Increase Awareness: Help patients and caregivers recognize the dangers of low blood sugar (hypoglycemia) and how to treat it.
• Improve Teamwork: Encourage "shared decision-making," where patients, caregivers, and doctors work together to make health choices.
• Test Feasibility: See if it is easy and helpful for people with memory loss to use these interactive displays in their daily lives.
• Understand Experiences: Learn how the thoughts and feelings of patients and families affect how they manage diabetes.

By using these interactive displays, the researchers hope to make it easier for families to understand their health needs and communicate better with their medical team.

Participants will:

• Answer a survey about how they manage their diabetes
• Learn how to use a Continuous Glucose Monitor and wear it for 14 days
• Answer 3 brief telephone surveys during these 14 days
• Complete a clinic visit with their doctor and answer a final survey on how this visit went using the CGM ASSIST report

Study Overview

• Status: Recruiting
• Conditions: Hypoglycemia; Diabetes; Dementia; Alzheimer's Disease (Incl Subtypes)
• Intervention / Treatment: Device: Continuous Glucose Monitoring

Detailed Description

Background and Clinical Significance Over 11 million Americans aged 65 and older live with diabetes mellitus (DM), and an estimated 13-20% of this population also has Alzheimer's disease and related dementias (ADRD). Hypoglycemia is a serious and frequent complication in this population, affecting 10-25% of patients and increasing the risk of coma, macrovascular events, and death.

A harmful cycle exists in ADRD-DM management: cognitive impairment hinders the detection of hypoglycemia and the management of glucose levels, while low glucose levels further impair cognition. Although clinical guidelines recommend de-intensifying medications and simplifying routines to reduce risk, these guidelines are often not implemented in clinical practice.

The Role of Continuous Glucose Monitoring (CGM) Continuous glucose monitoring (CGM) devices are effective tools for detecting hypoglycemia by tracking glucose levels every 5-15 minutes. While CGM has proven feasible in older adults without cognitive impairment, research indicates that standard CGM data reports are often difficult for patients and caregivers to interpret. This lack of interpretability creates a barrier to shared decision-making regarding behavior modifications, glycemic targets, and medication de-intensification.

Study Objective: CGM ASSIST This study aims to address these translational gaps by developing and testing CGM ASSIST. This intervention adapts standard CGM technology by adding interactive information displays (novel companion information guides) designed specifically for the ADRD-DM population and their caregivers.

The study follows a multi-phase approach:

Characterization of Needs: Identifying the unmet needs and decision-making processes of patient-caregiver dyads using CGM.

User-Centered Design: Engaging patients, caregivers, and clinicians in a design process to create the CGM ASSIST interactive reports.

Pilot Testing: Conducting a clinical trial to assess the feasibility, usability, and impact of the CGM ASSIST reports on shared decision-making and individualized care.

The long-term goal of this research is to improve the characterization of decision-making in adults with MCI and ADRD and to provide tools that help families identify and address unmet medical needs through better interpretation of clinical data.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: April Savoy, PhD; Phone Number: 317-278-2194; Email: asavoy@iu.edu
• Study Contact Backup: Name: Nina Johnson, MA; Phone Number: 317-274-9086; Email: kj83@regenstrief.org

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Eskenazi Health
      • Contact: Patricia Noblet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient-Caregiver Dyads; Participants will wear a continuous glucose monitor	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.
No Intervention: Patient-Caregiver Dyads & Clinicians (first iteration); Participants will participate in the first iteration of the user-centered design process.
No Intervention: Patient-Caregiver Dyads & Clinicians (second iteration); Participants will participate in the second iteration of the user-centered design process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility- Recruitment	Total number of participants enrolled divided by the total participants screened as eligible.	8 months
Feasibility- Retention	Total number of participants who completed the study divided by the total number of participants enrolled in the study.	2 months
Feasibility- CGM Device Adherence	This measures data completeness. Total number of days CGM worn and active divided by the total number of days in the observation period.	14 days
System Usability Scale	The System Usability Scale (SUS) is a 10-item validated questionnaire used to evaluate the usability of the CGM ASSIST interactive information display. Participants rate each item on a 5-point Likert scale ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). To calculate the final SUS score, the response for each odd-numbered item is reduced by 1, and the response for each even-numbered item is subtracted from 5. These adjusted scores are then summed and multiplied by 2.5. The total score ranges from 0 to 100. A higher score indicates better usability (e.g., a score above 68 is generally considered above average).	2 months
CollaboRATE Questionnaire	The CollaboRATE questionnaire is a 3-item validated patient-reported measure used to assess the level of shared decision-making during clinical encounters. The three items focus on how much effort was made: 1) to help the participant understand their health issues, 2) to listen to what matters most to the participant, and 3) to include the participant's preferences in the choice of next steps. Each item is scored on a 5-point Likert scale ranging from 1 (No effort was made) to 5 (Every effort was made). For each participant, a total score is calculated by summing the scores of the three items. The total score ranges from 3 to 15. A higher score indicates a higher perceived level of shared decision-making.	2 months
Number of Changes in Diabetes Management	This measure tracks the total number of management changes made to a participant's diabetes care plan based on medical record review. A "change" is defined as any of the following: 1) Initiation of new medications or technology, 2) New referrals to specialists or community services, 3) Discontinuation of existing medications, and 4) Modification (increase or decrease) of current medication dosages.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia - Time Below Range (TBR)	The percentage of time the participant spent with glucose levels below the target range. Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation]. This includes Level 1 hypoglycemia (54-69 mg/dL) and Level 2 hypoglycemia (<54 mg/dL).	14 days
Glucose Level - Time In Range (TIR)	Percentage of time the participant spent within the target glucose range of 70-180 mg/dL. Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation].	14 days
Glucose Management Indicator (GMI)	Estimated HbA1c percentage based on the average glucose levels captured by the CGM. Automated calculation based on 14 days of CGM data [CGM performs calculation]	14 days
Glucose Variability (%GV)	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). Calculation as the coefficient of variation (%CV). The goal for stable glycemic control is a variability of ≤36% [CGM performs calculation]	14 days
Mean Glucose Level	This mean is calculated by taking the total sum of glucose averages divided by the total number of days of glucose readings [CGM performs calculation].	14 days

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: April Savoy, PhD, Indiana University

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: November 11, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Actual): December 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Primary care; Continuous glucose monitoring; Shared decision-making; Human factors
• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurocognitive Disorders; Glucose Metabolism Disorders; Tauopathies; Neurodegenerative Diseases; Nutritional and Metabolic Diseases; Hypoglycemia; Alzheimer Disease; Diabetes Mellitus; Dementia; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: 13925; 1K01AG076971 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No