Clinical Study to Compare Various Dosing and Titration Guidelines of Insulin Delivered Via V-Go ® in Patients With Type 2 Diabetes Initiating Basal Bolus Therapy in Primary Care Offices (TITRATE)
Diabetes Type II
About this trial
This is an interventional treatment trial for Diabetes Type II
Eligibility Criteria
Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- Age ≥ 21 and ≤80 at time of study enrollment
- Ability to read and understand English
- BMI ≥ 25 kg/m2
- Weight less than or equal to 300 pounds.
- A1C ≥8 but ≤12% (most recent value within 4 weeks of baseline visit)
- Currently using any basal insulin therapy (NPH, Levemir, Lantus) with total daily dose of 30 to 120 units, and where basal dose is greater than the patient's BMI #
- Willing to attend their physician's office for follow-up visits
- Willing and able to understand and sign a written informed consent form (ICF) indicating that they agree to participate and have been informed of all pertinent aspects of the study
- Must be willing to take and record at least 3 glucose measurements per time period (pre-breakfast, lunch, dinner and bed) per week.
- Willing to opt-in into Valeritas Customer Care so that they can receive device support and reminders throughout the study
- Most recent primary care office visit at one of the participating sites.
Exclusion Criteria:Patients presenting with any the following exclusion criteria will not be eligible for enrollment into the study:
- Patient with confirmed Type 1 diabetes and/or patients with a weight greater than 300 lbs.
- Diagnosis of an Autoimmune disease affecting metabolism
- Currently using GLP-1 medications
- Current (within the last 6 months) or planned use of insulin pump for diabetes management or the use of U500 insulin.
- Ongoing participation in any clinical study
- Pregnant, lactating or intending to become pregnant
- Current chronic systemic steroid use
- Prior V-Go use
Sites / Locations
- GeisingerRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Titration Algorithm A
Titration Algorithm B
All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm A will use a fixed starting dose of either 2 clicks per meal (if on the V-Go 20) or 3 clicks per meal (if on the V-Go 30).
All patients that are initiated on a V-Go 20 will have a starting bolus dose of 6 clicks (12 units) during the day and all patients who are initiated on a V-Go 30 will have a starting bolus dose of 9 clicks (18 units) during the day. All patients randomized to Algorithm B will have 50% of their initial bolus dose given at the largest meal with less bolus insulin at the other meals as noted below: