Clinical trial NCT04807218: Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot)
Official title: Virta Intervention in CommuniTies in cOloRado (VICTOR-Pilot) Pilot Study to Improve Diabetes and Cardiovascular Risk in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Community Health Workers
Nutritional Ketosis
Patient Navigator
Diabetes
Referral
Lead sponsor: Colorado Prevention Center
Sponsor class: OTHER
Collaborators: name: Virta Health
First posted: 2021-03-19
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hemoglobin A1c (Percent)
timeFrame: 3.5 months
Secondary outcomes:
measure: Change in BMI
timeFrame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months
measure: Change in hemoglobin A1c
timeFrame: 3.5 months versus 7 months, baseline versus 10 months
measure: Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications
timeFrame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
Other outcomes:
measure: Acceptance of referral to continuous remote care
timeFrame: Baseline in Group 1 versus 3.5 months in Group 2
measure: Change in fasting triglyceride/HDL ratio
timeFrame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
measure: Change in LDL-cholesterol
timeFrame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
measure: Change in fasting glucose
timeFrame: Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months
measure: Acceptance/continuation of referral to continuous remote care
timeFrame: Baseline and 3.5 months
measure: Continuation of referral in Group 1 versus acceptance of referral in Group 2
timeFrame: 3.5 months
measure: Change in perceived health status
timeFrame: Baseline, 3.5 months, 7 months and 10 months
measure: Change in diabetes treatment satisfaction
timeFrame: Baseline, 3.5 months, 7 months and 10 months
measure: Count of 2-way contacts among subjects
timeFrame: 3.5 months and 7 months
measure: Acceptability of referral
timeFrame: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
measure: Acceptability of referral over time
timeFrame: Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months
Locations:
city: Craig
country: United States
facility: Northwest Colorado Health - Community Health Center & Prevention Services Craig
state: Colorado
city: Lamar
country: United States
facility: High Plains Community Health Center
state: Colorado
city: Salida
country: United States
facility: Chaffee County Public and Environmental Health
state: Colorado
Study officials:
affiliation: CPC Clinical Research
name: Cecilia Low Wang, MD
role: PRINCIPAL_INVESTIGATOR
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