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Active, not recruitingNCT03474692Updated Apr 1, 2025

Virta Health Registry

An observational study in Multiple Chronic Conditions, Chronic Disease and Disease Progression, sponsored by Virta Health. Active, not recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Virta Health · Observational

Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
50,000
Sex
All
01

Study summary

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

Read the detailed description

The purpose of this registry is to establish a research data repository, comprised of data generated in the course of providing clinical services to patients treated by Virta Health, to conduct secondary research on clinical interventions and chronic diseases.

The scope of research under this protocol includes the following:

  1. Examining the effectiveness, safety, and sustainability of Virta Health clinical interventions for treating chronic diseases and prevention of or regression of associated adverse health outcomes.
  2. Examining the cost-effectiveness and economic impact of Virta Health clinical interventions for treating chronic diseases and preventing or regressing associated adverse health outcomes.
  3. Identifying demographics, clinical characteristics, comorbidities, concomitant treatments, genetic variants, and behavioral phenotypes that predict more or less favorable clinical outcomes of subjects to Virta Health clinical interventions for chronic diseases.
  4. Examining the impact of mental health and the behavioral modification components of Virta Health clinical interventions on disease markers, comorbidities, and adverse health outcomes associated with Virta Health clinical interventions.
  5. Characterizing typical presentation patterns, genetic determinants, biochemistry, and pathophysiology of the chronic diseases treated by Virta Health.
  6. Exploring relationships between dietary composition and physiologic characteristics of chronic diseases.
  7. Exploring the interrelationship and common clinical/biological features of the various chronic diseases under treatment by Virta Health.
  8. Compiling case reports and case series of interesting disease presentations and outcomes, of the chronic diseases Virta Health treats, that may inform about the disease state and treatment responses.
  9. Validating the integration of technological aids into Virta Health clinical interventions. Where the impacts of devices are examined, devices will be FDA-approved and approved, marketed devices. No safety data will be collected on devices; rather, research will focus only on the feasibility of adding the device to the treatment program, its relationship with participant behaviors and health outcomes, and patient satisfaction attributable to the device.
  10. Understanding the relationships of patient needs, educational methods, and use of the Virta Health online Application, to subsequent patient satisfaction/clinical outcomes.
02

Conditions studied

  • Multiple Chronic Conditions
  • Chronic Disease
  • Disease Progression
  • Long-Term Care
  • Telemedicine
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients receiving medical care from Virta Health for their chronic condition, most commonly type 2 diabetes, prediabetes, and metabolic syndrome.

Eligibility criteria

Virta Health Patients

04

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
50,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. Change in Chronic Disease Status

    change in disease status or markers of disease status over time

    Time frame: 6+ months

06

Study locations

1 site
  • Virta Health
    Denver, Colorado 80216, United States
07

Registry details

Key details

Study ID
NCT03474692
Lead sponsor
Virta Health
Responsible party
Sponsor
First posted
Mar 22, 2018
Start date
Oct 7, 2019
Primary completion
Oct 2039 (estimated)
Completion
Oct 2039 (estimated)
Last update
Apr 1, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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