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Search / Trial NCT05643144

Enhancing Shared Decision-making to Guide Care for People With Dementia and Diabetes

Launched by INDIANA UNIVERSITY · Dec 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Continuous Glucose Monitoring Shared Decision Making Human Factors Primary Care

ClinConnect Summary

This clinical trial is focused on improving how patients with both diabetes and Alzheimer's Disease or related dementias (ADRD) make decisions about their care. The researchers want to understand the needs of patients and their caregivers while using a special device that continuously monitors blood sugar levels. They aim to develop an interactive tool that will help these patients and their caregivers make better choices about managing diabetes together.

To participate, you must be a patient with both mild cognitive impairment or ADRD and diabetes, actively taking medication for diabetes, and have a caregiver who interacts with you daily. Both you and your caregiver need to be comfortable speaking English and have internet access. If you decide to join, you can expect to share your experiences and needs, which will help shape the new decision-making tool. The trial is currently recruiting participants, and it’s a chance to contribute to important research that could improve care for others in similar situations.

Gender

ALL

Eligibility 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

About Indiana University

Indiana University, a leading research institution, is committed to advancing healthcare through innovative clinical trials and rigorous scientific inquiry. With a focus on improving patient outcomes, the university conducts a wide range of studies across various medical disciplines, leveraging its extensive resources and collaborative networks. Indiana University's dedication to ethical research practices and community engagement ensures that its clinical trials not only contribute to scientific knowledge but also prioritize participant safety and well-being. Through its commitment to excellence, Indiana University plays a pivotal role in shaping the future of medicine and enhancing public health.

Locations

Indianapolis, Indiana, United States

Patients applied

0 patients applied

Trial Officials

April Savoy, PhD

Principal Investigator

Indiana University School of Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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