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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643144
• Other study ID #: 13925
• Secondary ID: 1K01AG076971
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2023
• Est. completion date: August 17, 2026

Study information

• Verified date: April 2024
• Source: Indiana University
• Contact: April Savoy, PhD
• Phone: 317-278-2194
• Email: asavoy[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Aim 1: Characterize shared decision-making and unmet patient-caregiver dyads needs for patients with diabetes and Alzheimer's Disease and related dementias (ADRD) while using a continuous glucose monitoring (CGM) device.

Aim 2: Develop an interactive tool to enhance shared decision-making for diabetes management.

Description:

Aim 1: Patient-caregiver dyads will participant in a semi-structured interview to establish a baseline. The dyad will receive standard diabetes educational materials along with a CGM training and instructions for device use. Patients will then wear the CGM device for 14 days. Three follow-up interviews will take place during the 14-day scanning period, as well as a debrief interview following the scanning period for assessment and technical support.

Aim 2: Patient-caregiver dyads and clinicians will participate in a user-centered design session to guide the design of interactive information displays to improve the interpretability of CGM data.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: August 17, 2026
• Est. primary completion date: August 17, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease (Incl Subtypes)
• Dementia
• Diabetes
• Diabetes Mellitus
• Hypoglycemia

Intervention

Device:
• Continuous Glucose Monitoring
CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.

Locations

Country	Name	City	State
United States	Eskenazi Health	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient and Caregiver Unmet Needs (Aim 1)	Semi-structured Interviews: Baseline interview questions will be framed by validated psychometric measurements of hypoglycemia unawareness, fear of hypoglycemia, ADRD quality of life, and DM distress. Observation interviews will be conducted to elicit patients' and caregivers' perceptions about hypoglycemia and describe their specific risks (e.g., nutrition, resources, stress, finances). Debrief interviews will review CGM data with participants and ask clarifying questions to elicit descriptions of their overall experiences.	2 months
Primary	Level of Situation Awareness (Aim 2)	Contextual Inquiries: With and without examples of information displays present, we will invite participants questions related to identifying and reading glucose values (e.g., identify glycemic targets), and articulate perceived important information at specific decision points.	1 day
Secondary	Feasibility: Percentage of patients recruited (Aim 1)	Recruitment Percentage = Participant total/Eligible population total	1 year
Secondary	Feasibility: Retention rate of participants (Aim 1)	Retention Rate = Completed participant total/Recruited participant total	1 year
Secondary	Feasibility: CGM data completeness (Aim 1)	Count of total days CGM worn [CGM performs calculation]	2 months
Secondary	Hypoglycemia: Percentage of time below range (Aim 1)	Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored [CGM performs calculation]	2 months
Secondary	Severe Hypoglycemia: Percentage of time below range (Aim 1)	Percentage = glucose readings and time <54 mg/dL / total amount of readings and time monitored [CGM performs calculation]	2 months
Secondary	Percentage of time in range (Aim 1)	Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored [CGM performs calculation]	2 months
Secondary	Mean glucose (Aim 1)	Mean = sum of glucose readings / total amount of glucose readings [CGM performs calculation]	2 months
Secondary	Glucose management indicator (Aim 1)	Estimated A1C automated calculation based on 14 days of CGM data [CGM performs calculation]	2 months
Secondary	Glucose variability (Aim 1)	Oscillations in blood glucose levels: Measurement of fluctuations of glucose or other related parameters of glucose homoeostasis over a given interval of time (i.e., within a day, between days or longer term) [CGM performs calculation]	2 months