The Onduo Virtual Diabetes Clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists. Adults with T2D ( n = 594) who were evaluated by a VDC endocrinologist, remotely prescribed and mailed a real-time continuous glucose monitoring (rtCGM) device and used ≥1 sensor completed a CGM satisfaction questionnaire. The CGM satisfaction score was 4.5 ± 0.8 out of 5. Most respondents (94.7%) agreed/strongly agreed that they were comfortable inserting the sensor remotely and that rtCGM use improved understanding of the impact of eating (97.0%), increased diabetes knowledge (95.7%), and helped improve diabetes control when not wearing the sensor (79.4%). HbA1c ( n = 372) decreased from 7.7% ± 1.6% to 7.1% ± 1.2% ( P < 0.001; 10.2 months). These data suggest that it is feasible to provide rtCGM directly to individuals with T2D through a VDC without in-office training. Intermittent use of rtCGM was well-received by adults with T2D and was associated with improvement in HbA1c.

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 <70, 70-180, 181-250, and >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%; 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). 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. Trial Registration ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381

Background: Onduo’s Virtual Diabetes Clinic (VDC) incorporates a continuous glucose monitor (CGM), telemedicine, and a coaching app into the management of patients with type 2 diabetes (T2D). A recent meta-analysis of studies involving CGMs (Vigersky & McMahon 2019) showed HbA1c and time in range (%TIR) are strongly correlated. Methods: All patients in the program with CGM usage in the 45 days prior to a follow-up HbA1c were analyzed. Mean HbA1c and %TIR were added to the previously published meta-analysis plot where each study or cohort is represented by a single dot. Additionally, a regression model was fit on the patient-level data. Results: Patient-level results from the VDC confirm the two metrics are strongly correlated (r=.-78). At the population-level, a mean %TIR of 84% in 194 VDC patients with mean HbA1c of 7.0% is 18% higher than predicted from the meta-analysis regression line. Cohorts associated with the 3 T2D studies in the meta-analysis were the 3 with the highest %TIR versus predicted, and 1 study with mixed type 1/2 was also higher than predicted. Conclusions: Our findings add support to the strong correlation observed between TIR and A1c overall, and suggest potentially distinct calibrations in T1D vs. T2D populations. Additional CGM data in T2D will clarify if separate prediction formulae are necessary. Disclosure R.F. Dixon: Employee; Self; Onduo LLC. D.P. Miller: Employee; Self; Verily Life Sciences LLC. Stock/Shareholder; Self; Verily Life Sciences LLC. A. Majithia: Consultant; Self; Onduo LLC. A. Armento Lee: Employee; Self; Verily Life Sciences LLC. S. Robertson: Employee; Self; Verily Life Sciences LLC. M. Germanos: None. H. Zisser: Employee; Self; Verily Life Sciences LLC. Stock/Shareholder; Self; Verily Life Sciences LLC.

Background The Onduo virtual care program for people with type 2 diabetes (T2D) includes a mobile app, remote lifestyle coaching, connected devices, and telemedicine consultations with endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices. In a previously described 4-month prospective study of this program, adults with T2D and baseline glycated hemoglobin (HbA1c) ≥8.0% to ≤12.0% experienced a mean HbA1c decrease of 1.6% with no significant increase in hypoglycemia. Objective The objective of this analysis was to evaluate medication optimization and management in the 4-month prospective T2D study. Methods Study participants received at least 1 telemedicine consultation with an Onduo endocrinologist for diabetes medication management and used RT-CGM intermittently to guide therapy and dosing. Medication changes were analyzed. Results Of 55 participants, 48 (87%) had a medication change consisting of a dose change, addition, or discontinuation. Of these, 15 (31%) participants had a net increase in number of diabetes medication classes from baseline. Mean time to first medication change for these participants was 36 days. The percentage of participants taking a glucagon-like peptide-1 receptor agonist increased from 25% (12/48) to 56% (n=27), while the percentages of participants taking a sulfonylurea or dipeptidyl peptidase 4 inhibitor decreased from 56% (n=27) to 33% (n=16) and 17% (n=8) to 6% (n=3), respectively. Prescriptions of other antidiabetic medication classes including insulin did not change significantly. Conclusions The Onduo virtual care program can play an important role in providing timely access to guideline-based diabetes management medications and technologies for people with T2D. Trial Registration ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381

Introduction: Diabetes self-management training (DSMT) is clinically effective but places a heavy burden on patients. Personalized coaching delivered via scalable mobile app platforms has the potential to provide much needed patient support. Objectives: This study assessed feasibility and participant experience of a new mobile app-based platform for delivering DSMT to people with type 2 diabetes (T2D). The primary objective was to evaluate participant enrollment (recruitment into the study and completing first sign-in). Engagement with app features and health coach for the study duration was also evaluated. Methods: Adults with T2D were enrolled into a 4-week prospective, single arm, observational study of the T2D App-based program. The T2D App provided medication reminders, meal logging, blood glucose (BG) tracking, and secure text messaging with a health coach. Participant engagement, satisfaction, participation in self-management behaviors, and finger stick BG results were also measured. Results: Of 67 participants recruited 99% (66) were able to sign-in to the app and 64 of 67 (96%) completed the 4-week program. The majority of program participants used the T2D App daily (median 100% of days, mean 95% of days). Engagement rates in coach messaging and BG logging exceeded 95% of subjects and were sustained across the study duration. Average blood glucose (AG) in the study participants decreased from week 1 to week 4 (mean -7.8 mg/dL, sd 20.3, P=0.008). The subgroup of individuals with starting AG greater than 154 mg/dL (n=13) experienced the largest declines in AG (mean -29.6 mg/dL, sd 17.9, P&lt;0.0001). Conclusion: This initial feasibility study of a T2D App-based diabetes management program successfully enrolled participants and sustained their engagement. A decrease in AG was observed which, if sustained, would be clinically significant. Future studies with long term glycemic endpoints and an active control group are needed to validate this observation. Disclosure J.B. Hernandez: Employee; Self; Verily Life Sciences LLC.. A. Armento Lee: None. S. Robertson: Employee; Self; Verily Life Sciences LLC. C. Silver: Employee; Self; Verily Life Sciences LLC. A. Majithia: Employee; Self; Onduo.