title: Use of V-Go®Insulin Delivery Device in Patients with Sub-optimally Controlled Diabetes Mellitus: A Retrospective Analysis from a Large Specialized Diabetes System.
abstract: Tight glycemic control and timely treatment can improve outcomes in patients with diabetes yet many remain sub-optimally controlled. The objective of the current study was to evaluate the effect of switching patients with sub-optimally controlled diabetes to the V-Go®(Valeritas Inc., Bridgewater, NJ, USA) Disposable Insulin Delivery device.
  
  
  
  A retrospective analysis of electronic medical records was conducted to assess patients with sub-optimal glycemic control defined as a glycated hemoglobin (HbA1c) >7%, switched to V-Go. Blood glucose control defined as change from baseline in HbA1c, prescribed insulin doses, body weight, concomitant anti-hyperglycemic agents, and reported hypoglycemia were collected prior to switching to V-Go and during V-Go use.
  
  
  
  Two-hundred and four patients were evaluated during the study period. Overall, there was a significant decrease in HbA1c after switching to V-Go at the 14- and 27-week follow-up visits. The least-squares mean (LSM) change in HbA1c (95% confidence interval) from baseline to 14 weeks was -1.53% (-1.69% to -1.37%; P < 0.001), and from baseline to 27 weeks was -1.79% (-1.97% to -1.61%; P < 0.001). Significant reductions in mean HbA1c were achieved at both visits in all patient subsets: Patients with type 2 and type 1/latent autoimmune diabetes in adults (LADA); patients using insulin at baseline and patients naïve to insulin at baseline. Patients administering insulin at baseline required significantly less insulin on V-Go (86-99 LSM units/day at baseline to 58 LSM units/day at 27 weeks; P < 0.001). Across all patients, reported hypoglycemic events were no more frequent on V-Go than on previous therapy.
  
  
  
  V-Go is safe and effective in patients with sub-optimally controlled diabetes requiring insulin therapy. Glycemic control improved significantly, less insulin was required, and hypoglycemic events were similar after patients switched to insulin delivery by V-Go.
  
  
  
  Valeritas, Inc.
authors.affiliation: Diabetes America, Plano, TX, USA.
authors.forename: Rosemarie
authors.initials: R
authors.lastname: Lajara
authors.affiliation: Diabetes America, San Antonio, TX, USA.
authors.forename: Dianne A
authors.initials: DA
authors.lastname: Fetchick
authors.affiliation: Department of Mathematics and Statistics, University of Central Oklahoma, Edmond, OK, USA.
authors.forename: Tracy L
authors.initials: TL
authors.lastname: Morris
authors.affiliation: Valeritas Inc., Bridgewater, NJ, USA. cnikkel@valeritas.com.
authors.forename: Carla
authors.initials: C
authors.lastname: Nikkel
keywords: Basal-bolus; Diabetes; Hyperglycemia; Insulin; Intensified; Mealtime; Prandial; V-Go®