Onduo Virtual Diabetes Clinic Study (VDC)

Verily Life Sciences

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Device: Onduo App

Study type: Interventional

Funder types: Industry

Identifiers

NCT03865381

100901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Virtual Diabetes Clinic

Other group

Description:

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.

Treatment:

Device: Onduo App