Flash glucose monitoring is an FDA-approved and widely clinically available, glucose monitoring technology that is worn on the body and measures glucose values every 15 minutes, storing this data for up to 14 days. The Freestyle Libre Pro is already used as a diagnostic technology in clinical care. It provides a full 24-hour glucose profile for each day that the sensor is worn and that can be correlated with daily activities, medication administration, food intake, and other factors that are contextually relevant in meeting glycemic goals for an individual patient. In this study, patients referred to Endocrinology for specialty diabetes care will be randomized to an in-person visit as is typically done or to wear the Freestyle Libre Pro placed by staff at their primary care clinic. Patients who wear the Freestyle Libre Pro will have a professional interpretation of their glucose data completed by an endocrinologist as well as a remote eConsult completed using this glucose data and information from their medical record. The recommendations from the eConsult regarding medication and lifestyle adjustment as well as potential referral on to see Endocrinology will be implemented by the primary care physician at their clinical discretion. The investigators will utilize glycemic measures including hemoglobin A1c, number of clinical visits (outpatient, inpatient and emergency department) for diabetes care, patient reported outcomes including self-efficacy, and patient and provider assessments of burden to determine if eConsults utilizing flash glucose monitoring technology are non-inferior to in-person visits with a diabetes specialist.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
87
Completion of electronic consult utilizing data collected from flash glucose monitoring
Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.
Boston Medical Center
Boston, Massachusetts, United States
Hemoglobin A1c (A1c) at baseline
A1c will be obtained as standard of care and values documented in the medical record.
Time frame: baseline
Hemoglobin A1c (A1c) at 3 months
A1c will be obtained as standard of care and values documented in the medical record.
Time frame: 3 months
Hemoglobin A1c (A1c) at 6 months
A1c will be obtained as standard of care and values documented in the medical record.
Time frame: 6 months
Hemoglobin A1c (A1c) at 12 months
A1c will be obtained as standard of care and values documented in the medical record.
Time frame: 12 months
Percentage change in A1c to 6 months
The percent change in A1c will be calculated from baseline to six months
Time frame: baseline, 6 months
Percentage change in A1c to 12 months
The percent change in A1c will be calculated from baseline to 12 months
Time frame: baseline, 12 months
Proportion of patients with A1c <7%
The proportion of participants with A1c \<7% (ADA target) will be calculated.
Time frame: 6 months, 12 months
Proportion of patients with A1c <8%
The proportion of participants with A1c \<8% (ADA target) will be calculated.
Time frame: 6 months, 12 months
Glycemic control based on A1c
A1c reduction of \> 1% with 20% non-inferiority margin
Time frame: 12 months
Number of clinical visits for diabetes care
The number of clinical visits (outpatient, inpatient and emergency department) for diabetes care will be calculated for each participant
Time frame: 12 months
Patient assessment of care burden
Modified assessment of perceived research burden
Time frame: within 2 weeks of the physician visit or eConsult
Provider assessment of acceptability
Results from a 16 item post intervention questionnaire developed by the investigators will be used to assess provider acceptability. It includes 10 questions with a 5 item Likert scale from 1= Strongly disagree to 5= Strongly agree that asks about the usefulness, feasibility and how much they liked the eConsult and the physician visits. There are also 2 open-ended questions soliciting qualitative information about the intervention.
Time frame: at baseline, 6 months, and completion of study period
Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire
Patient disease burden will be measured by the validated Problem Areas in Diabetes-5 question (PAID-5) survey. The five questions are from the original 20 item PAID survey (specifically questions 3, 6, 12, 16, and 19) and each has a 5-point Likert scale ranging from "not a problem" (score of 0) to "serious problem" (score of 4). The possible total scores of the PAID-5 ranges from 0 to 20, with higher scores implying greater emotional distress.
Time frame: at baseline and 6 months
Efficacy of embedded clinical pharmacists
Changes in hemoglobin A1c will be used to assess the efficacy of the embedded clinical pharmacists
Time frame: baseline, 3, 6, and 12 months
Cost effectiveness analysis (CEA)
A Cost-Effectiveness Analysis will be done to compare the costs and health gains for the eConsult and standard of care interventions.
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Time frame: 12 months