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

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.

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