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Onduo Virtual Diabetes Clinic Study (VDC)

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ClinicalTrials.gov Identifier: NCT03865381
Recruitment Status : Completed
First Posted : March 6, 2019
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Verily Life Sciences LLC

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Device: Onduo App Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Onduo Virtual Diabetes Clinic Study
Actual Study Start Date : February 8, 2019
Actual Primary Completion Date : February 12, 2020
Actual Study Completion Date : October 15, 2020

Arm Intervention/treatment
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.
Device: Onduo App
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 Outcome Measures :
  1. Mean change in hemoglobin A1c [ Time Frame: 4 months ]
    Mean change in hemoglobin A1c from enrollment to 4 months


Secondary Outcome Measures :
  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 CGM summary measures from the first wear period versus the final wear period including glycemic variability, time spent in glycemic range, and mean glucose. [ Time Frame: 4 Months ]
    Mean change in Time in Range between the first and second CGM wear periods, where time in range is the proportion of readings between 70 and 180 mg/dL over the full wear time for a single CGM.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865381


Locations
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United States, California
Palo Alto Medical Foundation
Palo Alto, California, United States, 94301
United States, Pennsylvania
Premier Medical Associates
Monroeville, Pennsylvania, United States, 15146
Sponsors and Collaborators
Verily Life Sciences LLC
Investigators
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Principal Investigator: Amit Majithia, MD Onduo
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT03865381    
Other Study ID Numbers: 100901
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases