Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorIndiana University
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
patient has terminal illness
use of an automated insulin delivery system
patient is receiving dialysis
patient is taking ascorbic acid during monitoring period
Trial design
Design model
Single group
Treatments tested in this trial
Continuous Glucose Monitoring
DeviceCGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.
Treatment groups
62 Participants
are divided into 1 treatment groupGroup A: Patient-Caregiver DyadsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility- Recruitment
Total number of participants enrolled divided by the total participants screened as eligible.
Time frame
8 months2
Feasibility- Retention
Total number of participants who completed the study divided by the total number of participants enrolled in the study.
Time frame
2 months3
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.
Time frame
14 days4
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).
Time frame
2 monthsSecondary outcomes
1
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).
Time frame
14 days2
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 \[CGM performs calculation\].
Time frame
14 days3
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 \[CGM performs calculation\]
Time frame
14 days4
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% \[CGM performs calculation\]
Time frame
14 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov