Onduo Virtual Diabetes Clinic Study

Study Overview
=================
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.

Official Title
-----------------
Onduo Virtual Diabetes Clinic Study

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Device: Onduo App


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Virtual Diabetes Clinic<br>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<br>* 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.<br>|

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 |