Onduo Virtual Diabetes Clinic Study

Not Applicable

Completed

Brief 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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Virtual Diabetes Clinic	Onduo App	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.

Primary Outcome Measures

Name	Time	Method
Mean Change in Hemoglobin A1c	4 Months	Mean change in hemoglobin A1c from enrollment to 4 months

Secondary Outcome Measures

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

Locations (2): Premier Medical Associates
🇺🇸
Monroeville, Pennsylvania, United States
Palo Alto Medical Foundation
🇺🇸
Palo Alto, California, United States