Onduo Virtual Diabetes Clinic Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Verily Life Sciences LLC
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Mean Change in Hemoglobin A1c
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Onduo App (Device)
Outcomes
Primary Outcomes
Mean Change in Hemoglobin A1c
Time Frame: 4 Months
Mean change in hemoglobin A1c from enrollment to 4 months
Secondary Outcomes
- Time to First Change in Diabetes Medication or Dosage From Enrollment(4 Months)
- Mean Change in A1c(4 Months)
- Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.(4 Months)
- Change in Weight From Enrollment(4 Months)
- Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.(4 Months)
- Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.(4 Months)