Onduo Virtual Diabetes Clinic Study

Diabetes Mellitus, Type 2 Clinical Trial

— VDC  

Official title:

Onduo Virtual Diabetes Clinic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03865381
• Other study ID #: 100901
• Status: Completed
• Phase: N/A
• Start date: February 8, 2019
• Est. completion date: October 15, 2020

Study information

• Verified date: March 2021
• Source: Verily Life Sciences LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 15, 2020
• Est. primary completion date: February 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	Premier Medical Associates	Monroeville	Pennsylvania
United States	Palo Alto Medical Foundation	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Verily Life Sciences LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change in Hemoglobin A1c	Mean change in hemoglobin A1c from enrollment to 4 months	4 Months
Secondary	Change in Weight From Enrollment	Change in weight from enrollment to 4 months	4 Months
Secondary	Time to First Change in Diabetes Medication or Dosage From Enrollment	Change in diabetes medication or dosage from enrollment	4 Months
Secondary	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
Secondary	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
Secondary	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
Secondary	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