Clinical trial NCT03865381: Onduo Virtual Diabetes Clinic Study
Official title: Onduo Virtual Diabetes Clinic Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Verily Life Sciences LLC
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mean Change in Hemoglobin A1c
timeFrame: 4 Months
Secondary outcomes:
measure: Change in Weight From Enrollment
timeFrame: 4 Months
measure: Time to First Change in Diabetes Medication or Dosage From Enrollment
timeFrame: 4 Months
measure: Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.
timeFrame: 4 Months
measure: Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.
timeFrame: 4 Months
measure: Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.
timeFrame: 4 Months
measure: Mean Change in A1c
timeFrame: 4 Months
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Palo Alto Medical Foundation
state: California
city: Monroeville
country: United States
facility: Premier Medical Associates
state: Pennsylvania
Study officials:
affiliation: Onduo
name: Amit Majithia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Majithia AR, Erani DM, Kusiak CM, Layne JE, Lee AA, Colangelo FR, Romanelli RJ, Robertson S, Brown SM, Dixon RF, Zisser H. Medication Optimization Among People With Type 2 Diabetes Participating in a Continuous Glucose Monitoring-Driven Virtual Care Program: Prospective Study. JMIR Form Res. 2022 Apr 5;6(4):e31629. doi: 10.2196/31629.
citation: Majithia AR, Kusiak CM, Armento Lee A, Colangelo FR, Romanelli RJ, Robertson S, Miller DP, Erani DM, Layne JE, Dixon RF, Zisser H. Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial. J Med Internet Res. 2020 Aug 28;22(8):e21778. doi: 10.2196/21778.