Onduo Virtual Diabetes Clinic Study (VDC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03865381|
Recruitment Status : Recruiting
First Posted : March 6, 2019
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: Onduo App||Not Applicable|
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.
|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|
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.
- Mean change in hemoglobin A1c [ Time Frame: 4 months ]Mean change in hemoglobin A1c from enrollment to 4 months
- Change in weight from enrollment [ Time Frame: 4 months ]change in weight from enrollment to 4 months
- Time to first change in diabetes medication or dosage from enrollment [ Time Frame: 4 months ]change in diabetes medication or dosage from enrollment
- 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.
- 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.
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
|Contact: Riddhi Kapooremail@example.com|
|Contact: Scott Robertsonfirstname.lastname@example.org|
|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|
|Principal Investigator:||Amit Majithia, MD||Onduo|