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Diabetes Mellitus, Type 2VICTORNCT04807218

Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

A study testing Virta Health in people with Diabetes Mellitus, Type 2, run by Colorado Prevention Center at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Virta Health
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
3 sitesUnited States
Study dates
2 Mar 2021to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Northwest Colorado Health - Community Health Center & Prevention Services Craig

    Craig, Colorado, 81625

  • High Plains Community Health Center

    Lamar, Colorado, 81052

  • Chaffee County Public and Environmental Health

    Salida, Colorado, 81201

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Virta Health
Keywords
Community Health Workers, Nutritional Ketosis, Patient Navigator, Diabetes, Referral
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virta HealthBehavioural

    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.

Study groups in NCT04807218
Study groupRoleWhat they receive
Nutritional Ketosis Intervention ReferralActive comparatorThe 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.
Receives: Behavioral: Virta Health
CHHS Standard Care - Delayed Referral to Nutritional Ketosis InterventionActive comparatorAll 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).
Receives: Behavioral: Virta Health

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 3.5 months

Secondary outcomes (3)

  1. Change in BMI

    Among Group 1 versus Group 2 subjects, change in body mass index (kg/m2)

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

  2. Change in hemoglobin A1c

    Among Group 1 versus Group 2 subjects, difference in hemoglobin A1c

    Measured: 3.5 months versus 7 months, baseline versus 10 months

  3. Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications

    Among Group 1 versus Group 2 subjects, difference in:

    • number of anti-hyperglycemic medications
    • doses of anti-hyperglycemic medications

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2021
  2. Study start2 Mar 2021
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04807218
Sponsor's protocol ID
VIRT-001
Acronym
VICTOR
Status last verified
Feb 2025
First submitted
16 Mar 2021
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yaemsiri S, Alfier JM, Moy E, Rossen LM, Bastian B, Bolin J, Ferdinand AO, Callaghan T, Heron M. Healthy People 2020: Rural Areas Lag In Achieving Targets For Major Causes Of Death. Health Aff (Millwood). 2019 Dec;38(12):2027-2031. doi: 10.1377/hlthaff.2019.00915.

    PubMed 31794308

  • American Diabetes Association. 1. Improving Care and Promoting Health in Populations: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S7-S14. doi: 10.2337/dc21-S001.

    PubMed 33298412

  • Lee JY, Lee SWH. Telemedicine Cost-Effectiveness for Diabetes Management: A Systematic Review. Diabetes Technol Ther. 2018 Jul;20(7):492-500. doi: 10.1089/dia.2018.0098. Epub 2018 May 29.

    PubMed 29812965

  • McKenzie AL, Hallberg SJ, Creighton BC, Volk BM, Link TM, Abner MK, Glon RM, McCarter JP, Volek JS, Phinney SD. A Novel Intervention Including Individualized Nutritional Recommendations Reduces Hemoglobin A1c Level, Medication Use, and Weight in Type 2 Diabetes. JMIR Diabetes. 2017 Mar 7;2(1):e5. doi: 10.2196/diabetes.6981.

    PubMed 30291062

  • Bhanpuri NH, Hallberg SJ, Williams PT, McKenzie AL, Ballard KD, Campbell WW, McCarter JP, Phinney SD, Volek JS. Cardiovascular disease risk factor responses to a type 2 diabetes care model including nutritional ketosis induced by sustained carbohydrate restriction at 1 year: an open label, non-randomized, controlled study. Cardiovasc Diabetol. 2018 May 1;17(1):56. doi: 10.1186/s12933-018-0698-8.

    PubMed 29712560

  • Hallberg SJ, McKenzie AL, Williams PT, Bhanpuri NH, Peters AL, Campbell WW, Hazbun TL, Volk BM, McCarter JP, Phinney SD, Volek JS. Author Correction: Effectiveness and Safety of a Novel Care Model for the Management of Type 2 Diabetes at 1 Year: An Open-Label, Non-Randomized, Controlled Study. Diabetes Ther. 2018 Apr;9(2):613-621. doi: 10.1007/s13300-018-0386-4.

    PubMed 29508274

  • Krantz MJ, Coronel SM, Whitley EM, Dale R, Yost J, Estacio RO. Effectiveness of a community health worker cardiovascular risk reduction program in public health and health care settings. Am J Public Health. 2013 Jan;103(1):e19-27. doi: 10.2105/AJPH.2012.301068. Epub 2012 Nov 15.

    PubMed 23153152

  • Centers for Disease Control and Prevention. Diabetes Basics: Type 2 diabetes. Page last reviewed: May 30, 2019. https://www.cdc.gov/diabetes/basics/type2.html. Accessed 06 January 2021.

  • Kazemian P, Shebl FM, McCann N, Walensky RP, Wexler DJ. Evaluation of the Cascade of Diabetes Care in the United States, 2005-2016. JAMA Intern Med. 2019 Oct 1;179(10):1376-1385. doi: 10.1001/jamainternmed.2019.2396.

    PubMed 31403657

  • Stellefson M, Dipnarine K, Stopka C. The chronic care model and diabetes management in US primary care settings: a systematic review. Prev Chronic Dis. 2013;10:E26. doi: 10.5888/pcd10.120180.

    PubMed 23428085

  • Egbujie BA, Delobelle PA, Levitt N, Puoane T, Sanders D, van Wyk B. Role of community health workers in type 2 diabetes mellitus self-management: A scoping review. PLoS One. 2018 Jun 1;13(6):e0198424. doi: 10.1371/journal.pone.0198424. eCollection 2018.

    PubMed 29856846

  • Understanding Scope and Competencies: A Contemporary Look at the United States Community Health Worker Field: Progress Report of the Community Health Worker (CHW) Core Consensus (C3) Project: Building National Consensus on CHW Core Roles, Skills, and Qualities [Internet], 2016. Available from: http://files.ctctcdn.com/a907c850501/1c1289f0-88cc-49c3-a238-66def942c147.pdf. Accessed 04 November 2020.

  • Lee SWH, Chan CKY, Chua SS, Chaiyakunapruk N. Comparative effectiveness of telemedicine strategies on type 2 diabetes management: A systematic review and network meta-analysis. Sci Rep. 2017 Oct 4;7(1):12680. doi: 10.1038/s41598-017-12987-z.

    PubMed 28978949

  • Faruque LI, Wiebe N, Ehteshami-Afshar A, Liu Y, Dianati-Maleki N, Hemmelgarn BR, Manns BJ, Tonelli M; Alberta Kidney Disease Network. Effect of telemedicine on glycated hemoglobin in diabetes: a systematic review and meta-analysis of randomized trials. CMAJ. 2017 Mar 6;189(9):E341-E364. doi: 10.1503/cmaj.150885. Epub 2016 Oct 31.

    PubMed 27799615

  • Marcolino MS, Maia JX, Alkmim MB, Boersma E, Ribeiro AL. Telemedicine application in the care of diabetes patients: systematic review and meta-analysis. PLoS One. 2013 Nov 8;8(11):e79246. doi: 10.1371/journal.pone.0079246. eCollection 2013.

    PubMed 24250826

Questions about this trial

What is this clinical trial studying?

A study testing Virta Health in people with Diabetes Mellitus, Type 2, run by Colorado Prevention Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in hemoglobin A1c (Percent) (time frame: 3.5 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04807218, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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