NCT04089202

Diabetes eConsult Non-Inferiority Study

Comparing Electronic Versus In-Person Access to Specialty Diabetes Expertise

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes

Interventions

Type	Name	Description
OTHER	eConsult	Completion of electronic consult utilizing data collected from flash glucose monitoring
OTHER	Standard of care	Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.

Timeline

• Start date: 2020-02-03
• Primary completion: 2022-09-27
• Completion: 2022-09-27
• First posted: 2019-09-13
• Last updated: 2023-02-24

Locations

1 site across 1 country: United States