Improving decision-making for patients with dementia and diabetes
Official title: Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
Run by Indiana University · NCT05643144 · Data updated 2026-11-12
This study is trying to help patients with dementia and diabetes, along with their caregivers, make better decisions by testing a new tool that makes it easier to understand glucose monitoring data.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 62 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Status | Recruiting |
| Started | September 29, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT05643144 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patient-caregiver dyads where the patient has both diabetes and a diagnosis of mild cognitive impairment or Alzheimer's Disease.
✕Probably not a fit
Patients with terminal illnesses or those using automated insulin delivery systems may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to enhance shared decision-making for patient-caregiver dyads dealing with diabetes and Alzheimer's Disease or related dementias. Participants will undergo semi-structured interviews to identify their needs while using a continuous glucose monitoring (CGM) device. Following a 14-day period of CGM usage, the study will develop an interactive tool to improve the understanding of CGM data for both patients and caregivers. The approach focuses on user-centered design to ensure the tool meets the specific needs of the dyads involved.
Why it matters
Potential benefit: If successful, this study could lead to improved diabetes management and quality of life for patients with dementia.
How similar studies have gone: While there have been studies focusing on diabetes management and decision-making, this specific approach integrating CGM with dementia care is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Patient-Caregiver Dyad Inclusion Criteria: * 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: * 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
Where it's running
-
Eskenazi Health
Indianapolis, Indiana, United States Recruiting
Study contacts
- Principal investigator: April Savoy, PhD — Indiana University
- Study coordinator: April Savoy, PhD
- Email: asavoy@iu.edu
- Phone: 317-278-2194
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.