Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

Sponsor
Colorado Prevention Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04807218
Collaborator
Virta Health (Industry)
60
3
2
13
20
1.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Virta Health
N/A

Detailed 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:
  1. 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

  2. To assess patient-reported outcomes of continuous remote care as compared with standard care

  3. To determine enrollment rate (offered vs accepted) in patients with type 2 diabetes living in rural communities referred to continuous remote care.

  4. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot) Pilot Study to Improve Diabetes and Cardiovascular Risk in Rural Communities
Actual Study Start Date :
Mar 2, 2021
Anticipated Primary Completion Date :
Apr 2, 2022
Anticipated Study Completion Date :
Apr 2, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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.

Active Comparator: 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).

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.

Outcome Measures

Primary Outcome Measures

  1. Change in hemoglobin A1c (Percent) [3.5 months]

    Change from baseline hemoglobin A1c (Percent) among patients referred to continuous remote care (Group 1) versus standard care (Group 2)

Secondary Outcome Measures

  1. Change in BMI [Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months]

    Among Group 1 versus Group 2 subjects, change in body mass index (kg/m2)

  2. Change in hemoglobin A1c [3.5 months versus 7 months, baseline versus 10 months]

    Among Group 1 versus Group 2 subjects, difference in hemoglobin A1c

  3. Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications [Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months]

    Among Group 1 versus Group 2 subjects, difference in: number of anti-hyperglycemic medications doses of anti-hyperglycemic medications

Other Outcome Measures

  1. Acceptance of referral to continuous remote care [Baseline in Group 1 versus 3.5 months in Group 2]

    Proportion agreeing to participate in continuous remote care in Group 1 at baseline versus at 3.5 months in Group 2

  2. Change in fasting triglyceride/HDL ratio [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

  3. Change in LDL-cholesterol [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 LDL-cholesterol

  4. Change in fasting glucose [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 glucose

  5. Acceptance/continuation of referral to continuous remote care [Baseline and 3.5 months]

    Among Group 1 subjects, proportion agreeing to participate in continuous remote care

  6. Continuation of referral in Group 1 versus acceptance of referral in Group 2 [3.5 months]

    Among Group 1 versus Group 2 subjects, proportion agreeing to participate/continue in continuous remote care

  7. Change in perceived health status [Baseline, 3.5 months, 7 months and 10 months]

    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).

  8. Change in diabetes treatment satisfaction [Baseline, 3.5 months, 7 months and 10 months]

    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.

  9. Count of 2-way contacts among subjects [3.5 months and 7 months]

    Among Group 1 and Group 2 subjects, evaluation in active engagement as assessed by number of 2-way contacts.

  10. Acceptability of referral [Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months]

    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

  11. Acceptability of referral over time [Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Northwest Colorado Health - Community Health Center & Prevention Services Craig Craig Colorado United States 81625
2 High Plains Community Health Center Lamar Colorado United States 81052
3 Chaffee County Public and Environmental Health Salida Colorado United States 81201

Sponsors and Collaborators

  • Colorado Prevention Center
  • Virta Health

Investigators

  • Principal Investigator: Cecilia Low Wang, MD, CPC Clinical Research

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Colorado Prevention Center
ClinicalTrials.gov Identifier:
NCT04807218
Other Study ID Numbers:
  • VIRT-001
First Posted:
Mar 19, 2021
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Colorado Prevention Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022