An interventional study of Virta Health in Diabetes Mellitus, Type 2, sponsored by Colorado Prevention Center. Completed at 3 sites in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Colorado Prevention Center · Not applicable, Interventional, and Treatment
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 determine the durability of a continuous remote care intervention when paired with ongoing community health worker support
Exploratory:
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 51 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →Colorado Prevention Center is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
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)
Time frame: 3.5 months
Change in BMI
Among Group 1 versus Group 2 subjects, change in body mass index (kg/m2)
Time frame: 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
Time frame: 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
Time frame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
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
Time frame: Baseline in Group 1 versus 3.5 months in Group 2
Change in fasting triglyceride/HDL ratio
Among Group 1 versus Group 2 subjects, change from in fasting triglyceride/HDL ratio
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
Plan to share: No
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Colorado Prevention Center