Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Virta Health


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nutritional Ketosis Intervention Referral<br>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<br>* 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.<br>|
| Active Comparator: CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Health Workers, Nutritional Ketosis, Patient Navigator, Diabetes, Referral