Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)

Colorado Prevention Center51 enrolled

Overview

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: 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

Virta HealthBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

Northwest Colorado Health - Community Health Center & Prevention Services Craig

Craig, Colorado, United States

High Plains Community Health Center

Lamar, Colorado, United States

Chaffee County Public and Environmental Health

Salida, Colorado, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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