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Completed

NCT Number: NCT04807218

Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwest Colorado Health - Community Health Center & Prevention Services Craig, Craig, Colorado, United States

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About this study

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:

  • To assess the effects of referral to continuous remote care as compared with standard care on body weight and on body mass index
  • To assess the effects of referral to continuous remote care as compared with standard care on number and doses of anti-hyperglycemic medications
  • To determine the durability of a continuous remote care intervention when paired with ongoing community health worker support

Exploratory:

  • 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
  • To assess patient-reported outcomes of continuous remote care as compared with standard care
  • To determine enrollment rate (offered vs accepted) in patients with type 2 diabetes living in rural communities referred to continuous remote care.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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. 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

Other outcomes

  1. 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

  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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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).

  8. 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.

  9. 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.

  10. 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

  11. 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.

Sponsors and collaborators

Lead sponsor

Colorado Prevention Center

Other

Collaborators

  • Virta Health

Registry information

Official study title

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

Acronym: VICTOR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2021
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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