NCT03865381

Onduo Virtual Diabetes Clinic Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Verily Life Sciences LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DEVICE	Onduo App	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.

Timeline

• Start date: 2019-02-08
• Primary completion: 2020-02-12
• Completion: 2020-10-15
• First posted: 2019-03-06
• Last updated: 2021-09-24
• Results posted: 2021-09-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study