JMIR Publications

ABSTRACT

Background:

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 (rtCGM) devices for intermittent use.

Objective:

This prospective, single-arm study evaluated glycemic outcomes associated with participation in the VDC program for 4 months.

Methods:

Adults aged ≥18 years with T2D and a baseline HbA1c of ≥8.0% to ≤12.0% were enrolled from 2 primary care centers from February through 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 VDC endocrinologist for diabetes medication review. Participants were asked to use a rtCGM device (Dexcom G6, Dexcom, San Diego, CA) and wear six 10-day sensors (60 days total sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c from baseline at 4 months. Other endpoints included change in weight and in rtCGM glycemic metrics including percent time <70, 70-180, 181-250 and >250 mg/dL. CGM metrics were calculated from an initial 10-day period within 30 days of enrollment to a 10-day follow-up period >90 days from enrollment, with a data sufficiency requirement of >70% of possible readings. Changes in blood pressure (BP) and serum lipids at 4 months were also evaluated.

Results:

Participants (n=55) were (mean±SD): 57.3±11.6 years of age, BMI 33.7±7.2 and 40.0% female. HbA1c decreased significantly (P < .001) by -1.6%±1.0 from 8.9%±1.0 at baseline to 7.3%±0.9 at 4 months. When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by -1.2%±0.6 and -2.4%±1.3, respectively (both P < .001). CGM-measured (n=43) percent time in target range (TIR) 70-180 mg/dL increased 10.2% ± 20.5, from 65.4% ± 23.2 to 75.5% ± 22.7 (P = .002), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time in hyperglycemia 181-250 and >250 mg/dL decreased by 7.2% ± 15.4 (P = .005) and 3.0% ± 9.4 (P = .01), respectively, with no change in percent time <70 mg/dL. Mean weight decreased by 9.0 ± 10.4 lb (P < .001). Significant improvements were also observed in systolic BP, total cholesterol, low-density lipoprotein cholesterol and triglycerides (P = .04 to < .001).

Conclusions:

Participants in the 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 BP were also observed. In conclusion, the 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 rtCGM. Clinical Trial: ClinicalTrials.gov NCT03865381