Onduo Virtual Diabetes Clinic Study
| Status: | Recruiting |
|---|---|
| Conditions: | Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/8/2019 |
| Start Date: | February 8, 2019 |
| End Date: | August 1, 2020 |
| Contact: | Riddhi Kapoor |
| Email: | riddhikapoor@google.com |
| Phone: | 650-214-4161 |
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.
after 4 months of participation in the Onduo Virtual Diabetes Clinic (VDC) in individuals
with Type 2 diabetes and suboptimal glycemic control.
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.
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.
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
We found this trial at
2
sites
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