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Onduo Virtual Diabetes Clinic Study (VDC)

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ClinicalTrials.gov Identifier: NCT03865381
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
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)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : August 30, 2019
Estimated Study Completion Date : August 1, 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.



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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


Contacts
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Contact: Riddhi Kapoor 650-214-4161 riddhikapoor@google.com
Contact: Scott Robertson 650-214-4161 robertsonscott@verily.com

Locations
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United States, California
Palo Alto Medical Foundation Not yet recruiting
Palo Alto, California, United States, 94301
Contact: Robert Romanelli    650-321-4121      
United States, Pennsylvania
Premier Medical Associates Recruiting
Monroeville, Pennsylvania, United States, 15146
Contact: Francis Colangelo    412-457-0060 ext 4310      
Sponsors and Collaborators
Verily Life Sciences LLC
Investigators
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Principal Investigator: Amit Majithia, MD Onduo

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Responsible Party: Verily Life Sciences LLC
ClinicalTrials.gov Identifier: NCT03865381     History of Changes
Other Study ID Numbers: 100901
First Posted: March 6, 2019    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: February 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
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