Abstract

BackgroundThe Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use.ObjectiveThis prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months.MethodsAdults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated.ResultsParticipants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring–measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001).ConclusionsParticipants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM.Trial RegistrationClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381

Highlights

  • In recent years, there has been a dramatic increase in telehealth programs for the management of diabetes [1]

  • When stratified by baseline glycated hemoglobin HDL (HbA1c) of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%) and 2.4% (SD 1.3%), respectively

  • Erhardt et al [4] and Vigersky et al [5] have reported on the use of intermittent real-time continuous glucose monitoring (RT-continuous glucose monitoring (CGM)) in a population with type 2 diabetes (T2D) in a 52-week, two-arm, randomized controlled trial (RCT) that compared a 12-week active intervention of intermittent RT-CGM use to self-monitoring blood glucose

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Summary

Introduction

There has been a dramatic increase in telehealth programs for the management of diabetes [1]. There is growing recognition that advanced technology, including continuous glucose monitoring (CGM) devices, can play an essential role in diabetes care for people with type 2 diabetes (T2D), regardless of their treatment regimen [3,4,5,6,7]. Availability of live video consultations with board-certified endocrinologists for medication management and the ability to remotely prescribe CGM devices are unique components of the VDC. The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use

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