Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor–Driven Virtual Diabetes Clinic: Prospective Trial (Preprint)
Authors: Majithia Amit R , Kusiak Coco M , Armento Lee Amy , Colangelo Francis R , Romanelli Robert J , Robertson Scott , Miller David P , Erani David M , Layne Jennifer E , Dixon Ronald F , Zisser Howard 
Published: July 2020

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 (RT-CGM) devices for intermittent use.

OBJECTIVE

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

METHODS

Adults 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 &lt;70, 70-180, 181-250, and &gt;250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated.

RESULTS

Participants (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%; <i>P</i>&lt;.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and &gt;9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; <i>P</i>&lt;.001) and 2.4% (SD 1.3%; <i>P</i>&lt;.001), respectively. Continuous glucose monitoring–measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; <i>P</i>=.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 &gt;250 mg/dL decreased by 7.2% (SD 15.4; <i>P</i>=.005) and 3.0% (SD 9.4; <i>P</i>=.01), respectively. There was no change in percent time &lt;70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; <i>P</i>&lt;.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (<i>P</i>=.04 to P=&lt;.001).

CONCLUSIONS

Participants 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.

CLINICALTRIAL

ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381