Diabetes Mellitus, Type 2
Conditions
Keywords
Community Health Workers, Nutritional Ketosis, Patient Navigator, Diabetes, Referral
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.
Interventions
BEHAVIORALVirta Health
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.
Sponsors
Virta Health
Colorado Prevention Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hemoglobin A1c (Percent) | 3.5 months | Change from baseline hemoglobin A1c (Percent) among patients referred to continuous remote care (Group 1) versus standard care (Group 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI | Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus10 months | Among Group 1 versus Group 2 subjects, change in body mass index (kg/m2) |
| Change in hemoglobin A1c | 3.5 months versus 7 months, baseline versus 10 months | Among Group 1 versus Group 2 subjects, difference in hemoglobin A1c |
| Change in number and/or doses of anti-hyperglycemic medications • doses of anti-hyperglycemic medications | Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months | Among Group 1 versus Group 2 subjects, difference in: * number of anti-hyperglycemic medications * doses of anti-hyperglycemic medications |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptance/continuation of referral to continuous remote care | Baseline and 3.5 months | Among Group 1 subjects, proportion agreeing to participate in continuous remote care |
| Continuation of referral in Group 1 versus acceptance of referral in Group 2 | 3.5 months | Among Group 1 versus Group 2 subjects, proportion agreeing to participate/continue in continuous remote care |
| Change in perceived health status | Baseline, 3.5 months, 7 months and 10 months | Among Group 1 and Group 2 subjects, evaluation over time (i.e. 3 months post-intervention) in perceived health status as assessed by question 1 of the Short Form Health Survey (SF-1). |
| Acceptance of referral to continuous remote care | Baseline in Group 1 versus 3.5 months in Group 2 | Proportion agreeing to participate in continuous remote care in Group 1 at baseline versus at 3.5 months in Group 2 |
| Count of 2-way contacts among subjects | 3.5 months and 7 months | Among Group 1 and Group 2 subjects, evaluation in active engagement as assessed by number of 2-way contacts. |
| Acceptability of referral | Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months | Among Group 1 subjects at baseline 3.5 and 7 months, and Group 2 subjects at 3.5 and 7 months. Participants will be asked 'Did you complete the referral to Virta Health?' Yes/No |
| Acceptability of referral over time | Group 1: baseline, 3.5 months and 7 months / Group 2: 3.5 months and 7 months | Among Group 1 subjects at baseline 3.5 and 7 months, and Group 2 subjects at 3.5 and 7 months. Participants will be asked if they are still continuing their treatment with Virta Health. |
| Change in diabetes treatment satisfaction | Baseline, 3.5 months, 7 months and 10 months | Among Group 1 and Group 2 subjects, evaluation over time at baseline, in diabetes treatment satisfaction as assessed by the Diabetes Treatment Satisfaction Questionnaire. The scale for the survey questions is 0-6. In general, a higher score indicates a higher level of satisfaction with diabetic treatment. |
| Change in fasting triglyceride/HDL ratio | Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months | Among Group 1 versus Group 2 subjects, change from in fasting triglyceride/HDL ratio |
| Change in LDL-cholesterol | Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months | Among Group 1 versus Group 2 subjects, change from in LDL-cholesterol |
| Change in fasting glucose | Baseline versus 3.5 months, 3.5 months versus 7 months, baseline versus 10 months | Among Group 1 versus Group 2 subjects, change from in fasting glucose |
Countries
United States
Outcome results
None listed