Clinical trial NCT04089202: Diabetes eConsult Non-Inferiority Study
Official title: Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes specialty care
Flash glucose monitoring
Clinical pharmacists
eConsults
Freestyle Libre sensor
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects age 18-80, inclusive
* Diagnosed with type 2 diabetes at least 6 months prior to screening
* Not previously seen within the prior three years in the endocrinology clinic for diabetes management
* Referred to endocrinology for diabetes care directly from primary care
* Willing to wear an Abbott® FreeStyle Libre Pro for 7-14 days
* English speaking
* Able and willing to complete questionnaires

Exclusion Criteria:

* Planned travel or surgery during the time of libre wear
* Patients without a diagnosis of type 2 diabetes, including individuals with type 1 diabetes and gestational diabetes
* Women referred for diabetes care during pregnancy, or while breastfeeding or who intend to become pregnant during involvement in this trial
* Currently using real time CGM or FGM system
* Concurrent involvement in another clinical trial using diabetes pharmacotherapy
* Individuals with active malignancy undergoing treatment with chemotherapy and/or high dose glucocorticoids
* Individuals with rheumatic disease undergoing treatment with high dose glucocorticoids
* Planned magnetic resonance imaging (MRI), computed tomography (CT) scan, or high-frequency electrical heat (diathermy) treatment during the time of Libre wear
* Any cognitive or other disorders, in the investigator's opinion, that may interfere with participation or ability to follow the study protocol

Primary outcomes:
measure: Hemoglobin A1c (A1c) at baseline
timeFrame: baseline
measure: Hemoglobin A1c (A1c) at 3 months
timeFrame: 3 months
measure: Hemoglobin A1c (A1c) at 6 months
timeFrame: 6 months
measure: Hemoglobin A1c (A1c) at 12 months
timeFrame: 12 months
measure: Percentage change in A1c to 6 months
timeFrame: baseline, 6 months
measure: Percentage change in A1c to 12 months
timeFrame: baseline, 12 months
measure: Proportion of patients with A1c <7%
timeFrame: 6 months, 12 months
measure: Proportion of patients with A1c <8%
timeFrame: 6 months, 12 months
measure: Glycemic control based on A1c
timeFrame: 12 months
Secondary outcomes:
measure: Number of clinical visits for diabetes care
timeFrame: 12 months
measure: Patient assessment of care burden
timeFrame: within 2 weeks of the physician visit or eConsult
measure: Provider assessment of acceptability
timeFrame: at baseline, 6 months, and completion of study period
measure: Patient self efficacy and disease burden based on diabetes self management questionnaire and problem areas in diabetes short five-item short form questionnaire
timeFrame: at baseline and 6 months
measure: Efficacy of embedded clinical pharmacists
timeFrame: baseline, 3, 6, and 12 months
measure: Cost effectiveness analysis (CEA)
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Endocrinology, Diabetes & Nutrition
name: Devin Steenkamp, MD
role: PRINCIPAL_INVESTIGATOR
References: