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Continuous Glucose Monitoring / Dementia / Diabetes · Interventional Study
ClinicalTrials.gov · August 20, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for an ongoing feasibility study of a digital shared decision-making tool (CGM ASSIST) for people with dementia and diabetes. The study measures recruitment, retention, device adherence, usability, and shared decision-making engagement over 12 months. No results are reported in this record; the study is currently recruiting.
Interventional, Single Group, Open label, Health Services Research purpose. Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia, Hypoglycemia; age from 65 Years. Intervention: Patient-Caregiver Dyads. n = 62. 1 site: United States.
This is a registry record for an ongoing feasibility study of a digital shared decision-making tool (CGM ASSIST) for people with dementia and diabetes. The study measures recruitment, retention, device adherence, usability, and shared decision-making engagement over 12 months. No results are reported in this record; the study is currently recruiting.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
This study is designed to test whether a digital decision-support tool can improve shared decision-making and awareness of hypoglycemia in people with dementia and diabetes. Results will inform whether the intervention is feasible and acceptable before any efficacy trial.
This is a feasibility study of an interventional digital tool in a small, estimated sample of 62 participants with dementia and diabetes; results are not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
This study is designed to test whether a digital decision-support tool can improve shared decision-making and awareness of hypoglycemia in people with dementia and diabetes. Results will inform whether the intervention is feasible and acceptable before any efficacy trial.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT05643144). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 62 participants (ESTIMATED). Conditions: Diabetes, Alzheimer's Disease (Incl Subtypes), Dementia, Hypoglycemia. Interventions: DEVICE: Continuous Glucose Monitoring. Primary outcome measures: Feasibility- Recruitment , 8 months; Feasibility- Retention , 2 months; Feasibility- CGM Device Adherence , 14 days; System Usability Scale , 2 months; CollaboRATE Questionnaire , 2 months; Number of Changes in Diabetes Management , 12 months. Brief summary: 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
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