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| Name | Class |
|---|---|
| Virta Health | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Ketosis Intervention Referral | Active Comparator | 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 | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in fasting triglyceride/HDL ratio |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilia Low Wang, MD | CPC Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwest Colorado Health - Community Health Center & Prevention Services Craig | Craig | Colorado | 81625 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31794308 | Background | 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. | |
| 33298412 | Background | 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. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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|
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:
| 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
| Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| High Plains Community Health Center |
| Lamar |
| Colorado |
| 81052 |
| United States |
| Chaffee County Public and Environmental Health | Salida | Colorado | 81201 | United States |
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