American Prevention Center is starting a clinical trial of Virta Intervention in CommuniTies
Photo by Gabriel Benois
Colorado Prevention Center is enrolling patients into the clinical trial investigating Virta Intervention in CommuniTies in Colorado (VICTOR).
Virta Health is the collaborator in this study.
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 trial is designed to enroll male and female 18 to 79 years and is being conducted in the High Plains Community Health Center, Lamar, Colorado and Chaffee County Public and Environmental Health, Salida, Colorado, United States.
The study start date is March 2, 2021.
Among the inclusion criteria are:
- Age 18 - 79 years old
- Type 2 diabetes mellitus diagnosis by self-report and/or medical history
- Taking 1 or more antihyperglycemic medications
- Current HbA1c > 7.5%
- Body mass index (BMI) 25 kg/m2 or greater
- Capable of engaging in virtual care
There are a number of conditions that do not allow participation, such as:
- Type 1 diabetes.
- Pregnant or planning pregnancy within the next 9 months.
- Lactating.
- Admission for diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) within the last 12 months.
- Life expectancy <1 year.
- Postural orthostatic tachycardia syndrome (POTS) and/or recurrent syncope
and others.
.Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT04807218