Diabetes eConsult Non-Inferiority Study

Boston Medical Center (BMC)

Status: Terminated

Conditions: Diabetes

Treatments: Other: Standard of care; Other: eConsult

Study type: Interventional

Funder types: Other

Identifiers

NCT04089202

H-38363

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

87 participants in 2 patient groups

In-person visit arm

Active Comparator group

Description:

In this arm, patients meeting eligibility criteria and consented into the study are randomized to an in-person visit with an Endocrinologist. This is currently the standard of care for patients referred for diabetes specialty care. Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences. Surveys will be administered to measure patient burden and self efficacy.

Treatment:

Other: Standard of care

Freestyle Libre sensor arm

Experimental group

Description:

In this arm, patients meeting eligibility criteria and consented into the study are randomized to have the Freestyle Libre Pro continuous glucose monitor (CGM) placed at their primary care clinic. The data collected from the diagnostic CGM will be utilized in conjunction with diet, exercise and medication logs provided by the patient and information from the patient's electronic medical record to complete an eConsult with treatment recommendations. Implementation of these recommendations will be per the primary care provider's discretion in conjunction with conversation with the patient in follow up visits. Surveys will be administered to measure patient burden and self efficacy.

Treatment:

Other: eConsult