Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Type 2
In brief
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.
Key facts
- Study ID
- NCT04807218
- Run by
- Colorado Prevention Center
- People needed
- 51
- Starts
- 2021-03-02
- Expected to finish
- 2024-08-30
- Last updated by the study team
- 2025-03-11
Who can join
Age: 18 and older, up to 79. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Able to provide electronic informed consent
- 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
You may not qualify if…
- 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
- 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)
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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