Onduo Virtual Diabetes Clinic Study

NCT03865381 | Completed Results FDA Device

• 1 other identifier: 100901
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Mean Change in Hemoglobin A1c

  Mean change in hemoglobin A1c from enrollment to 4 months

  4 Months

Secondary Outcomes (6)

• Change in Weight From Enrollment

  4 Months

• Time to First Change in Diabetes Medication or Dosage 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

• Change in Time Spent in Glycemic Range From the First Wear Period Versus the Final Wear Period.

  4 Months

Study Arms (1)

Virtual Diabetes Clinic

OTHER

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

Interventions

Onduo App DEVICE

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.

Virtual Diabetes Clinic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding
• Use of an insulin pump

Sponsors & Collaborators

• Verily Life Sciences LLC: lead

Study Sites (2)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Premier Medical Associates

Monroeville, Pennsylvania, 15146, United States

Location

Related Publications (2)

• 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.

  PMID: 35147501 DERIVED

• 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.

  PMID: 32856597 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Head of Clinical Science
• Organization: Verily Life Sciences

info@verily.com

(650) 253-0000

Study Officials

• Amit Majithia, MD

  Onduo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 6, 2019
• Study Start: February 8, 2019
• Primary Completion: February 12, 2020
• Study Completion: October 15, 2020
• Last Updated: September 24, 2021
• Results First Posted: September 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)