Status:
COMPLETED
Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)
Lead Sponsor:
Colorado Prevention Center
Collaborating Sponsors:
Virta Health
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-79 years
Phase:
NA
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 lifest...
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 remo...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2024
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04807218
Start Date
March 2 2021
End Date
August 30 2024
Last Update
March 11 2025
Active Locations (3)
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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