Improving decision-making for patients with dementia and diabetes
Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05643144 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with terminal illnesses or those using automated insulin delivery systems may not benefit from this study.
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 performed: While there have been studies focusing on diabetes management and decision-making, this specific approach integrating CGM with dementia care is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Indianapolis, Indiana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.