Overview
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
Description
Background and Clinical Significance Over 11 million Americans aged 65 and older live with diabetes mellitus (DM), and an estimated 13-20% of this population also has Alzheimer's disease and related dementias (ADRD). Hypoglycemia is a serious and frequent complication in this population, affecting 10-25% of patients and increasing the risk of coma, macrovascular events, and death.
A harmful cycle exists in ADRD-DM management: cognitive impairment hinders the detection of hypoglycemia and the management of glucose levels, while low glucose levels further impair cognition. Although clinical guidelines recommend de-intensifying medications and simplifying routines to reduce risk, these guidelines are often not implemented in clinical practice.
The Role of Continuous Glucose Monitoring (CGM) Continuous glucose monitoring (CGM) devices are effective tools for detecting hypoglycemia by tracking glucose levels every 5-15 minutes. While CGM has proven feasible in older adults without cognitive impairment, research indicates that standard CGM data reports are often difficult for patients and caregivers to interpret. This lack of interpretability creates a barrier to shared decision-making regarding behavior modifications, glycemic targets, and medication de-intensification.
Study Objective: CGM ASSIST This study aims to address these translational gaps by developing and testing CGM ASSIST. This intervention adapts standard CGM technology by adding interactive information displays (novel companion information guides) designed specifically for the ADRD-DM population and their caregivers.
The study follows a multi-phase approach:
Characterization of Needs: Identifying the unmet needs and decision-making processes of patient-caregiver dyads using CGM.
User-Centered Design: Engaging patients, caregivers, and clinicians in a design process to create the CGM ASSIST interactive reports.
Pilot Testing: Conducting a clinical trial to assess the feasibility, usability, and impact of the CGM ASSIST reports on shared decision-making and individualized care.
The long-term goal of this research is to improve the characterization of decision-making in adults with MCI and ADRD and to provide tools that help families identify and address unmet medical needs through better interpretation of clinical data.
Eligibility
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