Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

Diabetes Mellitus, Type 2 Clinical Trial

— VICTOR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04807218
• Other study ID #: VIRT-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Colorado Prevention Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Colorado Prevention Center	Virta Health

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. — View Citation

American Diabetes Association. 5. Facilitating Behavior Change and Well-being to Improve Health Outcomes: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S53-S72. doi: 10.2337/dc21-S005. — View Citation

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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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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. — View Citation

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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.

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* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptance of referral to continuous remote care	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
Other	Change in fasting triglyceride/HDL ratio	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
Other	Change in LDL-cholesterol	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
Other	Change in fasting glucose	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
Other	Acceptance/continuation of referral to continuous remote care	Among Group 1 subjects, proportion agreeing to participate in continuous remote care	Baseline and 3.5 months
Other	Continuation of referral in Group 1 versus acceptance of referral in Group 2	Among Group 1 versus Group 2 subjects, proportion agreeing to participate/continue in continuous remote care	3.5 months
Other	Change in perceived health status	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
Other	Change in diabetes treatment satisfaction	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
Other	Count of 2-way contacts among subjects	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
Other	Acceptability of referral	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
Other	Acceptability of referral over time	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
Primary	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	Change in BMI	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
Secondary	Change in hemoglobin A1c	Among Group 1 versus Group 2 subjects, difference in hemoglobin A1c	3.5 months versus 7 months, baseline versus 10 months
Secondary	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	Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months