Onduo Virtual Diabetes Clinic Study (VDC)

This is a prospective, single arm study designed to evaluate the change in hemoglobin A1c after 4 months of participation in the Onduo Virtual Diabetes Clinic (VDC) in individuals with Type 2 diabetes and suboptimal glycemic control.

The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services accessed via a software application (Onduo App). Eligible subjects are asked to use the Onduo App and commercially available FDA-regulated medical devices and non-medical devices, for up to 4 months. Subjects receive a continuous glucose monitor (CGM) and are asked to use the device for up to 6 wear cycles of 10 days each. Subjects are scheduled for a medical review via a face-to-face telemedicine consultation with a VDC Physician. Subjects may have their diabetes medications changed by a VDC Physician following their telemedicine visit. Information provided to a subject in the course of the study is not intended as a substitute for the subject's primary care provider's guidance. At the completion of the subject's study participation, the Onduo App will be deactivated and there will be no further data collection through the app. A1c levels and surveys are collected at 1 year follow-up.

The Onduo Virtual Diabetes Clinic (VDC) is the suite of diabetes management services including remote monitoring, diet/lifestyle coaching, medication management accessed via Onduo App and partner apps. Subjects will engage with a Care Lead through the App and will have a medical consultation via telemedicine with an Onduo VDC Physician.

The Onduo App is a software application which tracks data relevant to diabetes care, such as, but not limited to, medication, meal logs and glucose readings, and activity data. The Onduo App connects wirelessly to a Care Team Console through the Internet. The Onduo App may also connect wirelessly to commercially available FDA-regulated (i.e., cleared and approved) medical devices and non-medical devices through the subject's Smartphone.

Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period.

Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose.

Inclusion Criteria: Male and Female; 18 years of age or older Confirmed diagnosis of Type 2 diabetes mellitus Willing to use CGM and BGM A1c result ≥8.0% and ≤12.0% Receive their diabetes care from Premier Medical Associates or the Palo Alto Medical Foundation Own a Smartphone with a data plan and be the primary user of that smartphone Smartphone must use a supported Android OS or iOS Exclusion Criteria: Pregnant or breastfeeding Use of an insulin pump Any condition or situation that the Sponsor or Investigator determines as inappropriate for study inclusion

Majithia AR, Erani DM, Kusiak CM, Layne JE, Lee AA, Colangelo FR, Romanelli RJ, Robertson S, Brown SM, Dixon RF, Zisser H. Medication Optimization Among People With Type 2 Diabetes Participating in a Continuous Glucose Monitoring-Driven Virtual Care Program: Prospective Study. JMIR Form Res. 2022 Apr 5;6(4):e31629. doi: 10.2196/31629.

Majithia AR, Kusiak CM, Armento Lee A, Colangelo FR, Romanelli RJ, Robertson S, Miller DP, Erani DM, Layne JE, Dixon RF, Zisser H. Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial. J Med Internet Res. 2020 Aug 28;22(8):e21778. doi: 10.2196/21778.