Onduo Virtual Diabetes Clinic Platform Evaluation: A Pragmatic Comparative Effectiveness Trial in Primary Care

Diabetes Mellitus, Type 2 Clinical Trial

— OnduoVDC  

Official title:

Onduo Virtual Diabetes Clinic Platform Evaluation: A Pragmatic Comparative Effectiveness Trial in Primary Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04216602
• Other study ID #: HSC20190909X
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2019
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Jing Wang, PhD
• Phone: 210-450-8561
• Email: wangj1[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Onduo Virtual Diabetes Clinic Platform Evaluation: A Pragmatic Comparative Effectiveness Trial in Primary Care

Description:

More than 30 million Americans, nearly 10% of the U.S. population, have diabetes, with type 2 diabetes (T2D) accounting for over 90% of all diabetes cases. In addition, approximately 84.1 million Americans have prediabetes, a condition with high risk of advancing to T2D in 5 years if not treated. This high prevalence of diabetes has created an enormous financial burden on health care systems and has significantly affected the quality of life in those living with diabetes. With the increasing population of older adults with T2D, this public health concern is likely to become worse if not addressed.

Over the past decade, a growing body of evidence indicates that smartphones and connected devices have the potential to reduce the burden of diabetes while improving patient care. Access to continuous glucose monitoring (CGM) devices allows individuals to obtain a week of dense glycemic information with a single sensor application, obviating the need for finger sticks. CGM also provides patients with information regarding their glucose response to food intake and activities in real-time, which enables health providers and patients to set individualized lifestyle and medication adjustments to optimize glycemic control. Moreover, mobile app technology on smartphones has progressed to enable remote, on-demand connections with coaching and clinicians.

This study evaluates the Onduo Virtual Diabetes Clinic (VDC), a comprehensive diabetes management program that combines mobile app technology, connected devices including blood glucose (BG) meters and CGM devices, personalized lifestyle coaching, and remote clinical support from board-certified endocrinologists. The lifestyle and clinical guidance follow the best practices of the American Association of Diabetes Educators (AADE) Diabetes Education Curriculum and the American Diabetes Association (ADA) Standards of Care. This study focuses on evaluating the outcomes of the Onduo VDC in individuals with T2D with suboptimal glycemic control.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Self-reported diagnosis of T2D =1 year

• Receive their diabetes care from the 6 primary care practices in San Antonio, TX and the surrounding area for at least 6 months

• Able to read and speak English

• Able and willing to sign the Informed Consent Form

• Have a Google user account (a personal Gmail address or a GAIA account) or be willing to obtain an account and create a free Gmail address

• Own a Smartphone with a data plan and be the primary user of that smartphone

• Smartphone must use a supported Android OS or iOS and be compatible with Onduo and Dexcom apps

• Agree to provide a phone number and email address to enable feedback through communication

• Baseline A1c =8.0% and =12.0%

• Willing to use commercially available FDA-cleared blood glucose meter (BGM) and continuous glucose monitor (CGM)

• Agree to use the program Apps and communicate with Onduo care team at least 1 time/week for the initial 4 months

• Agree to have blood lab tests drawn

• Agree to have their diabetes medications managed and adjusted by an Onduo VDC physician

• Agree to comply with all study requirements

Exclusion Criteria:

• Pregnant or breastfeeding

• Malignant cancer in the previous 12 months (basal and squamous skin cancer will not be considered an exclusion)

• Any solid organ transplant(s)

• End stage (stage 4 or 5) renal disease, including dialysis

• Liver Failure

• Cystic Fibrosis

• Chronic Heart Failure (Class C, D)

• Pancreatic failure related diabetes

• Major psychiatric illness

• Self-reported adhesive allergy

• Use of an insulin pump (except Valeritas V-Go)

• Anticipated travel outside of the US for more than 7 consecutive days during the initial 4 months of study

• Employee of Verily Life Sciences, Sanofi, Onduo LLC, or Onduo PC

• Living in the same household or be a close family member or friend of a currently enrolled patient

• Any other condition or situation the Investigator determines as inappropriate for study inclusion

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Onduo Virtual Diabetes Clinic
A comprehensive diabetes management program that combines mobile app technology including blood glucose meters, central glucose monitoring and personalized lifestyle coaching with clinical support from board-certified endocrinologists.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Onduo LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in short term Glycated hemoglobin test (HbA1c)	Evaluation of change in HbA1c in subjects participating in Onduo VDC compared to usual care	Baseline and 4 months
Secondary	Weight change	Change in participants body mass up to a year	Baseline, 4, 7 and 12 months
Secondary	Change in Blood Pressure	Change in participants blood pressure up to a year	Baseline, 4, 7 and 12 months
Secondary	Medication attitudes	Change in attitude of participants to medications using the Merck-3 questionnaire	Baseline, 4, 7 and 12 months
Secondary	Medication Adherence	Change in adherence of participants to medications using the Morisky Medication Adherence scale 8 item	Baseline, 4, 7 and 12 months
Secondary	Diabetes distress	Change in diabetes distress using the Diabetes Distress Scale 17	Baseline, 4, 7 and 12 months
Secondary	Diabetes self-management patterns	Summary of diabetes self-care activities questionnaire	Baseline, 4, 7 and 12 months