Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

NCT04807218 | Completed DMC

• 1 other identifier: VIRT-001
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Community Health Workers; Nutritional Ketosis; Patient Navigator; Diabetes; Referral

Outcome Measures

Primary Outcomes (1)

• Change in hemoglobin A1c (Percent)

  Change from baseline hemoglobin A1c (Percent) among patients referred to continuous remote care (Group 1) versus standard care (Group 2)

  3.5 months

Secondary Outcomes (3)

• Change in BMI

  Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months

• Change 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

  Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months

Other Outcomes (11)

• Acceptance of referral to continuous remote care

  Baseline in Group 1 versus 3.5 months in Group 2

• Change in fasting triglyceride/HDL ratio

  Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months

• Change in LDL-cholesterol

  Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months

Study Arms (2)

Nutritional Ketosis Intervention Referral

ACTIVE COMPARATOR

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

CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention

ACTIVE COMPARATOR

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

Interventions

Virta Health BEHAVIORAL

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.

CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention; Nutritional Ketosis Intervention Referral

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 1 diabetes
• Pregnant or planning pregnancy within the next 9 months
• Lactating
• Admission for diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) within the last 12 months
• Life expectancy \<1 year
• Postural orthostatic tachycardia syndrome (POTS) and/or recurrent syncope
• 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)
• 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

Sponsors & Collaborators

• Colorado Prevention Center: lead
• Virta Health: collaborator

Study Sites (3)

Northwest Colorado Health - Community Health Center & Prevention Services Craig

Craig, Colorado, 81625, United States

Location

High Plains Community Health Center

Lamar, Colorado, 81052, United States

Location

Chaffee County Public and Environmental Health

Salida, Colorado, 81201, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Cecilia Low Wang, MD

  CPC Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 19, 2021
• Study Start: March 2, 2021
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: March 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)