Virta Intervention in CommuniTies in COloRado (VICTOR-Pilot)

Colorado Prevention Center Clinical Research

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Virta Health

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04807218

VIRT-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Nutritional Ketosis Intervention Referral

Active Comparator group

Description:

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.

Treatment:

Behavioral: Virta Health

CHHS Standard Care - Delayed Referral to Nutritional Ketosis Intervention

Active Comparator group

Description:

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).

Treatment:

Behavioral: Virta Health