Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)
NCT ID: NCT04807218
Last Updated: 2025-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
51 participants
INTERVENTIONAL
2021-03-02
2024-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
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.
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).
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
79 Years
ALL
Yes
Sponsors
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Virta Health
INDUSTRY
Colorado Prevention Center
OTHER
Responsible Party
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Principal Investigators
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Cecilia Low Wang, MD
Role: PRINCIPAL_INVESTIGATOR
CPC Clinical Research
Locations
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Northwest Colorado Health - Community Health Center & Prevention Services Craig
Craig, Colorado, United States
High Plains Community Health Center
Lamar, Colorado, United States
Chaffee County Public and Environmental Health
Salida, Colorado, United States
Countries
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References
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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.
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.
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.
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.
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.
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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.
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.
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.
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.
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.
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Sainsbury E, Kizirian NV, Partridge SR, Gill T, Colagiuri S, Gibson AA. Effect of dietary carbohydrate restriction on glycemic control in adults with diabetes: A systematic review and meta-analysis. Diabetes Res Clin Pract. 2018 May;139:239-252. doi: 10.1016/j.diabres.2018.02.026. Epub 2018 Mar 6.
Snorgaard O, Poulsen GM, Andersen HK, Astrup A. Systematic review and meta-analysis of dietary carbohydrate restriction in patients with type 2 diabetes. BMJ Open Diabetes Res Care. 2017 Feb 23;5(1):e000354. doi: 10.1136/bmjdrc-2016-000354. eCollection 2017.
Athinarayanan SJ, Adams RN, Hallberg SJ, McKenzie AL, Bhanpuri NH, Campbell WW, Volek JS, Phinney SD, McCarter JP. Long-Term Effects of a Novel Continuous Remote Care Intervention Including Nutritional Ketosis for the Management of Type 2 Diabetes: A 2-Year Non-randomized Clinical Trial. Front Endocrinol (Lausanne). 2019 Jun 5;10:348. doi: 10.3389/fendo.2019.00348. eCollection 2019.
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Other Identifiers
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VIRT-001
Identifier Type: -
Identifier Source: org_study_id
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