Virta Intervention in CommuniTies in COloRado (VICTOR-Pilot) (VICTOR)

March 7, 2025 updated by: Colorado Prevention Center

Virta Intervention in CommuniTies in COloRado (VICTOR-Pilot) Pilot Study to Improve Diabetes and Cardiovascular Risk in Rural Communities

The VICTOR study plans to include rural communities served by Colorado Heart Healthy Solutions (CHHS) program and find out whether participants will accept a referral to a comprehensive virtual lifestyle intervention, Virta Health. The Virta Health program induces nutritional ketosis to improve glucose control in individuals with type 2 diabetes. The study will inform the acceptability of the referral, the retention of participants in lifestyle intervention, and the durability of effects on glucose control after the lifestyle intervention has ended.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In rural communities served by Colorado Heart Healthy Solutions (CHHS), referral to a comprehensive remotely-delivered (virtual) continuous remote care to induce nutritional ketosis combined with remote medication management will improve glycemic control in patients with type 2 diabetes as compared with standard care. The study intervention is the referral. Subjects are not mandated to receive Virta treatment and are welcome to continue in the study whether or not the referral is accepted. 2 rural communities served by CHHS have been chosen as recruitment sites. Study patients will be randomized at the site level.

Objectives

Primary: To assess glycemic control in patients with type 2 diabetes living in a rural community referred to a comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management (termed "continuous remote care") as compared with those living in a rural community offered standard care.

Secondary:

  1. To assess the effects of referral to continuous remote care as compared with standard care on body weight and on body mass index
  2. To assess the effects of referral to continuous remote care as compared with standard care on number and doses of anti-hyperglycemic medications

  3. To determine the durability of a continuous remote care intervention when paired with ongoing community health worker support

    Exploratory:

  4. To assess the effects of referral to continuous remote care as compared with standard care on LDL-cholesterol, fasting glucose, and fasting triglyceride/HDL-cholesterol ratio
  5. To assess patient-reported outcomes of continuous remote care as compared with standard care
  6. To determine enrollment rate (offered vs accepted) in patients with type 2 diabetes living in rural communities referred to continuous remote care.
  7. To determine active engagement (number, timing, and types of 2-way contacts) and retention in patients with type 2 diabetes living in rural communities referred to continuous remote care.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Craig, Colorado, United States, 81625
        • Northwest Colorado Health - Community Health Center & Prevention Services Craig
      • Lamar, Colorado, United States, 81052
        • High Plains Community Health Center
      • Salida, Colorado, United States, 81201
        • Chaffee County Public and Environmental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Able to provide electronic informed consent
  2. Age 18 - 79 years old
  3. Type 2 diabetes mellitus diagnosis by self-report and/or medical history
  4. Taking 1 or more antihyperglycemic medications
  5. Current HbA1c > 7.5%
  6. Body mass index (BMI) 25 kg/m2 or greater
  7. Capable of engaging in virtual care

Exclusion Criteria:

  1. Type 1 diabetes
  2. Pregnant or planning pregnancy within the next 9 months
  3. Lactating
  4. Admission for diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) within the last 12 months
  5. Life expectancy <1 year
  6. Postural orthostatic tachycardia syndrome (POTS) and/or recurrent syncope
  7. Active severe psychiatric or medical condition(s) such as advanced renal (end-stage renal disease or CKD stage 4 or 5; eGFR <30 mL/min), cardiac (NYHA Class 4 heart failure), or hepatic dysfunction (Child-Pugh Class C)
  8. Any condition which in the opinion of the investigator would make the study unsuitable for the subject including investigator opinion regarding inability to comply with Virta instructions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nutritional Ketosis Intervention Referral
The comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management is the Virta treatment, and while on this treatment, subjects will have access to Virta health coaches and licensed medical providers who will perform medical therapy management, health coaching, nutrition and behavior change education, biometric feedback, and the option to participate in a community for peer support.
Behavioral: Virta Health
The comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management is the Virta treatment, and while on this treatment, subjects will have access to Virta health coaches and licensed medical providers who will perform medical therapy management, health coaching, nutrition and behavior change education, biometric feedback, and the option to participate in a community for peer support.
Active Comparator: CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention
All subjects will be enrolled in Colorado Heart Healthy Solutions (CHHS), which consists of community health worker (CHW) contact and sessions on: 1) cardiovascular disease knowledge; 2) Health behavior change through skill building to improve diet (e.g., portion sizes, increasing fruit/vegetable intake, reducing intake of sugar sweetened beverages, decreasing fast food meals, etc.), increase physical activity, and improve well-being, tailored to individual subjects' risk profile and self-identified goals; and 3) Connection to services including primary care, mental health services if needed, and relevant community programs to address barriers (e.g. food insecurity, need for legal help) or to promote behavior change (e.g. free/low cost exercise programs).
Behavioral: Virta Health
The comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management is the Virta treatment, and while on this treatment, subjects will have access to Virta health coaches and licensed medical providers who will perform medical therapy management, health coaching, nutrition and behavior change education, biometric feedback, and the option to participate in a community for peer support.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hemoglobin A1c (Percent)
Time Frame: 3.5 months
Change from baseline hemoglobin A1c (Percent) among patients referred to continuous remote care (Group 1) versus standard care (Group 2)
3.5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months
Among Group 1 versus Group 2 subjects, change in body mass index (kg/m2)
Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months
Change in hemoglobin A1c
Time Frame: 3.5 months versus 7 months, baseline versus 10 months
Among Group 1 versus Group 2 subjects, difference in hemoglobin A1c
3.5 months versus 7 months, baseline versus 10 months
Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications
Time Frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months

Among Group 1 versus Group 2 subjects, difference in:

  • number of anti-hyperglycemic medications
  • doses of anti-hyperglycemic medications
Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of referral to continuous remote care
Time Frame: Baseline in Group 1 versus 3.5 months in Group 2
Proportion agreeing to participate in continuous remote care in Group 1 at baseline versus at 3.5 months in Group 2
Baseline in Group 1 versus 3.5 months in Group 2
Change in fasting triglyceride/HDL ratio
Time Frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Among Group 1 versus Group 2 subjects, change from in fasting triglyceride/HDL ratio
Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Change in LDL-cholesterol
Time Frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Among Group 1 versus Group 2 subjects, change from in LDL-cholesterol
Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Change in fasting glucose
Time Frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Among Group 1 versus Group 2 subjects, change from in fasting glucose
Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Acceptance/continuation of referral to continuous remote care
Time Frame: Baseline and 3.5 months
Among Group 1 subjects, proportion agreeing to participate in continuous remote care
Baseline and 3.5 months
Continuation of referral in Group 1 versus acceptance of referral in Group 2
Time Frame: 3.5 months
Among Group 1 versus Group 2 subjects, proportion agreeing to participate/continue in continuous remote care
3.5 months
Change in perceived health status
Time Frame: Baseline, 3.5 months, 7 months and 10 months
Among Group 1 and Group 2 subjects, evaluation over time (i.e. 3 months post-intervention) in perceived health status as assessed by question 1 of the Short Form Health Survey (SF-1).
Baseline, 3.5 months, 7 months and 10 months
Change in diabetes treatment satisfaction
Time Frame: Baseline, 3.5 months, 7 months and 10 months
Among Group 1 and Group 2 subjects, evaluation over time at baseline, in diabetes treatment satisfaction as assessed by the Diabetes Treatment Satisfaction Questionnaire. The scale for the survey questions is 0-6. In general, a higher score indicates a higher level of satisfaction with diabetic treatment.
Baseline, 3.5 months, 7 months and 10 months
Count of 2-way contacts among subjects
Time Frame: 3.5 months and 7 months
Among Group 1 and Group 2 subjects, evaluation in active engagement as assessed by number of 2-way contacts.
3.5 months and 7 months
Acceptability of referral
Time Frame: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
Among Group 1 subjects at baseline 3.5 and 7 months, and Group 2 subjects at 3.5 and 7 months. Participants will be asked 'Did you complete the referral to Virta Health?' Yes/No
Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
Acceptability of referral over time
Time Frame: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
Among Group 1 subjects at baseline 3.5 and 7 months, and Group 2 subjects at 3.5 and 7 months. Participants will be asked if they are still continuing their treatment with Virta Health.
Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colorado Prevention Center

Collaborators

Virta Health

Investigators

  • Principal Investigator: Cecilia Low Wang, MD, CPC Clinical Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2021

Primary Completion (Actual)

August 30, 2024

Study Completion (Actual)

August 30, 2024

Study Registration Dates

First Submitted

March 16, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VIRT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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