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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
62
CGM education and glucose data collection for 14 days with a device. Interviews with dyads to assess experience and awareness of hypoglycemic events.
Eskenazi Health
Indianapolis, Indiana, United States
RECRUITINGPatient 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.
Time frame: 2 months
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.
Time frame: 1 day
Feasibility: Percentage of patients recruited (Aim 1)
Recruitment Percentage = Participant total/Eligible population total
Time frame: 1 year
Feasibility: Retention rate of participants (Aim 1)
Retention Rate = Completed participant total/Recruited participant total
Time frame: 1 year
Feasibility: CGM data completeness (Aim 1)
Count of total days CGM worn \[CGM performs calculation\]
Time frame: 2 months
Hypoglycemia: Percentage of time below range (Aim 1)
Percentage = glucose readings and time 54-69 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
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Time frame: 2 months
Severe Hypoglycemia: Percentage of time below range (Aim 1)
Percentage = glucose readings and time \<54 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
Time frame: 2 months
Percentage of time in range (Aim 1)
Percentage = glucose readings and time 70-180 mg/dL / total amount of readings and time monitored \[CGM performs calculation\]
Time frame: 2 months
Mean glucose (Aim 1)
Mean = sum of glucose readings / total amount of glucose readings \[CGM performs calculation\]
Time frame: 2 months
Glucose management indicator (Aim 1)
Estimated A1C automated calculation based on 14 days of CGM data \[CGM performs calculation\]
Time frame: 2 months
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) \[CGM performs calculation\]
Time frame: 2 months