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Completed

NCT Number: NCT03865381

Onduo Virtual Diabetes Clinic Study

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Palo Alto Medical Foundation, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Mean Change in Hemoglobin A1c

    Time frame: 4 Months

    Mean change in hemoglobin A1c from enrollment to 4 months

Secondary outcomes

  1. Change in Weight From Enrollment

    Time frame: 4 Months

    Change in weight from enrollment to 4 months

  2. Time to First Change in Diabetes Medication or Dosage From Enrollment

    Time frame: 4 Months

    Change in diabetes medication or dosage from enrollment

  3. Change in Mean Glucose From the First Wear Period Versus the Final Wear Period.

    Time frame: 4 Months

    Mean glucose was calculated from an initial wear period to a final wear period.

  4. Change in Glycemic Variability From the First Wear Period Versus the Final Wear Period.

    Time frame: 4 Months

    Coefficient of variation was calculated from an initial wear period to a final wear period.

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

    Time frame: 4 Months

    Percent time in Glycemic Range, 70 to 180 mg/dL, was calculated from an initial wear period to a final wear period.

  6. Mean Change in A1c

    Time frame: 4 Months

    Mean change in estimated A1c between the first and second CGM wear periods, where estimated A1c is a linear function of average blood glucose.

Sponsors and collaborators

Lead sponsor

Verily Life Sciences LLC

Industry

Registry information

Acronym: VDC

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2019
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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