The aim of the study is to observe patients with Type 2 Diabetes on basal insulin alone or basal insulin with oral agents can be efficiently and safely started with meal time insulin using U100 rapid acting insulin analog and V-Go® Disposable Insulin Delivery Device (V-Go) using one of two dose titration algorithms to achieve improved A1C at 4 months.
This study addresses the informational needs of Primary Care Physicians with regard to providing insulin dosing and titration information utilizing a V-Go disposable insulin delivery device. We look to compare two treatment arms of insulin dosing and titration in patients with Type 2 insulin-dependent diabetes - a fixed dose titration arm, and an arm where 50% of the insulin dose is given at the largest meal of the day. This study will provide practical information on glycemic control, dose requirements and safety in patients with Type 2 diabetes on basal insulin with or without oral anti-diabetic agents who are being primarily managed in the primary care office.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
Geisinger
Wilkes-Barre, Pennsylvania, United States
RECRUITINGA1C
Change change in A1C from baseline (randomization) to endpoint (approximately 16 weeks).
Time frame: 4 months
Change in glycemic control
• Difference in the change from baseline (randomization) to end of study visit at 4 months on glycemic control (as measured by A1C level) between the two treatment groups in a pragmatic clinical practice setting
Time frame: 4 months
Patient Treatment Satisfaction
• Between-group and within-group differences (baseline to end of study visit at 4 months) in patient treatment satisfaction in adult Type 2 patient with diabetes in a real world setting
Time frame: 4 months
Insulin Dose
• Total daily dose of insulin from baseline to end of study and to evaluate the between-group and within-group differences between the two dosing and titration arms
Time frame: 4 months
A1c at goal
Percentage of patient achieving a A1C of ≤7%
Time frame: 4 months
7 point glucose profile
Capture and analyze seven-point glucose profile at baseline and end of study
Time frame: 4 months
Hypoglycemia
Rates of hypoglycemic events and utilization
Time frame: 4 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.