title: Accuracy and Injection Force of the Gla-300 Injection Device Compared With Other Commercialized Disposable Insulin Pens.
abstract: BACKGROUND
  To deliver insulin glargine 300 U/mL (Gla-300), the widely used SoloSTAR(®) pen has been modified to allow for accurate and precise delivery of required insulin units in one-third of the volume compared with insulin glargine 100 U/mL, while improving usability. Here we compare the accuracy and injection force of 3 disposable insulin pens: Gla-300 SoloSTAR(®), FlexPen(®), and KwikPen™.
  
  
  METHODS
  For the accuracy assessment, 60 of each of the 3 tested devices were used for the delivery of 3 different doses (1 U, half-maximal dose, and maximal dose), which were measured gravimetrically. For the injection force assessment, 20 pens of each of the 3 types were tested twice at half-maximal and once at maximal dose, at an injection speed of 6 U/s.
  
  
  RESULTS
  All tested pens met the International Organization for Standardization (ISO) requirements for dosing accuracy, with Gla-300 SoloSTAR showing the lowest between-dose variation (greatest reproducibility) at all dose levels. Mean injection force was significantly lower for Gla-300 SoloSTAR than for the other 2 pens at both half maximal and maximal doses (P < .0271).
  
  
  CONCLUSIONS
  All tested pens were accurate according to ISO criteria, and the Gla-300 SoloSTAR pen displayed the greatest reproducibility and lowest injection force of any of the 3 tested devices.
authors: Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA dklonoff@diabetestechnology.org.
authors: David
authors: D
authors: Klonoff
authors: Diabetes Research Institute, Mills-Peninsula Health Services, San Mateo, CA, USA.
authors: Irina
authors: I
authors: Nayberg
authors: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors: Marissa
authors: M
authors: Thonius
authors: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors: Florian
authors: F
authors: See
authors: Zentrallaboratorium Deutscher Apotheker, Eschborn, Germany.
authors: Mona
authors: M
authors: Abdel-Tawab
authors: Sanofi-Aventis Deutschland GmbH, Frankfurt am Main, Germany.
authors: Frank
authors: F
authors: Erbstein
authors: Diabetes Klinik Bad Mergentheim, Bad Mergentheim, Germany.
authors: Thomas
authors: T
authors: Haak
mesh_terms: D004209:Disposable Equipment / Q000592:standards*; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007279:Injections, Subcutaneous / Q000295:instrumentation* / Q000592:standards*; D007328:Insulin / Q000008:administration & dosage*; D015203:Reproducibility of Results
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Gla-300 SoloSTAR; accuracy; injection force; insulin pen