SoloSTAR Prefilled Insulin Pens Accurate
A new study examining the dose accuracy of the SoloSTAR disposable insulin pen for diabetes patients, prefilled with Lantus (insulin glargine [rDNA origin] injection) or Apidra (insulin glulisine [rDNA origin] injection), found the pens accurately delivered all insulin doses within standard limits defined by the International Organization for Standardization (ISO).
Lantus SoloSTAR was approved by the U.S. Food and Drug Administration (FDA) on April 25, 2007. Apidra for use in the SoloSTAR prefilled disposable pen is currently under review at the FDA. The study, presented on May 2, 2008 at the 43rd Congress of the German Society for Diabetes (DDG) in Munich, Germany, examined the accuracy of both pens at multiple target dosages to determine the proportion of doses that fell within ISO ranges.
"For people with diabetes who use an insulin pen to deliver their insulin, dose accuracy is essential for their treatment," stated Norbert Hermanns, Ph.D., director of the Research Institute of the Diabetes Academy Mergentheim, Bad Mergentheim, Germany, and lead investigator in the study. "Based on the findings of this study, we concluded that the SoloSTAR pen is an accurate insulin delivery option for people with diabetes."
The study participants, a random sample of 60 hospital inpatients with type 1 and type 2 diabetes, were trained on correct use of the SoloSTAR pen. Participants were then asked to inject three target doses with Lantus into an insulin-sponge, in doses of 10 (low), 40 (medium) and 80 (high) units, and three doses of Apidra in doses of 5 (low), 15 (medium) and 30 (high) units. The quantity of insulin delivered was calculated by the weight of the insulin pens before and after injection. The order of the dosages was randomized. All doses (100%) were within the limits prescribed by the ISO standard (mean doses were only 0.9% to 1.3% below targets for Lantus, and 0.4% to 1.1% below targets for Apidra), and the data set was within the ISO-defined 97.5% confidence intervals at each dose.