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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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Palo Alto Medical Foundation
Palo Alto, California, United States
Premier Medical Associates
Monroeville, Pennsylvania, United States
Start Date
February 8, 2019
Primary Completion Date
February 12, 2020
Completion Date
October 15, 2020
Last Updated
September 24, 2021
60
ACTUAL participants
Onduo App
DEVICE
Lead Sponsor
Verily Life Sciences LLC
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062