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

Enhancing Shared Decision-making to Prompt and Guide Individualized Care for People With Alzheimer's Disease and Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 14 days
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CGM ASSIST, a digital tool that helps people with memory loss or dementia and diabetes understand their blood sugar readings. It aims to help patients, caregivers, and doctors make care choices together. Patients will wear a blood sugar monitor for 14 days, answer surveys, and visit their doctor.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • The patient has diabetes and mild cognitive impairment (memory or thinking problems) or Alzheimer’s disease or a related dementia.
  • The patient has active prescriptions for diabetes medicine.
  • The patient visited an Eskenazi or IU Health primary care clinic in the past 12 months.
  • The patient can agree to take part. If they cannot give legal consent, a legally authorized person must consent for them.
  • The patient has a caregiver age 18 or older who interacts with them daily or almost daily.
  • Both the patient and caregiver speak English.
  • Both live in the community, rather than a care facility.
  • The patient and caregiver have internet access.

Who can't join

  • The patient has a terminal illness, meaning an illness expected to lead to death.
  • The patient uses a system that automatically delivers insulin.
  • The patient receives dialysis, a treatment that filters the blood.
  • The patient takes ascorbic acid (vitamin C) during the monitoring period.
  • The patient has a medical device implanted in their body.
  • The patient has a bleeding disorder or existing sores or damaged skin on their arm.
  • The patient is allergic to medical adhesive (sticky material) or isopropyl alcohol (rubbing alcohol).
  • The patient plans to have medical imaging scans or diathermy (deep-heat treatment) during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (1)

IN