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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Onduo App

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Palo Alto Medical Foundation
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • Premier Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Virtual Diabetes Clinic; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Hemoglobin A1c	Mean change in hemoglobin A1c from enrollment to 4 months	4 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight From Enrollment	Change in weight from enrollment to 4 months	4 Months
Time to First Change in Diabetes Medication or Dosage From Enrollment	Change in diabetes medication or dosage from enrollment	4 Months
Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.	Mean glucose was calculated from an initial wear period to a final wear period.	4 Months
Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.	Coefficient of variation was calculated from an initial wear period to a final wear period.	4 Months
Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.	Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period.	4 Months
Mean Change in A1c	Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose.	4 Months

Collaborators and Investigators

• Sponsor: Verily Life Sciences LLC
• Investigators: Principal Investigator: Amit Majithia, MD, Onduo

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2019
• Primary Completion (Actual): February 12, 2020
• Study Completion (Actual): October 15, 2020

Study Registration Dates

• First Submitted: February 25, 2019
• First Submitted That Met QC Criteria: March 5, 2019
• First Posted (Actual): March 6, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 100901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No