title: [Evaluation of a new disposable insulin pen and injection habits of diabetes patients in everyday clinical practice].
abstract: Evaluation of a new disposable insulin pen and injection habits of diabetes patients in everyday clinical practice
  
  
  BACKGROUND
  Injection devices (pens) for insulin application play a major role in treatment acceptance and adherence in insulin-treated diabetes patients. The mechanical disposable pen SoloStar containing the insulin analogs glargine or glulisine (each 100 IE/ml) provides modern design with user-friendly handling features.
  
  
  METHODS
  In two independent, non-interventional, observational studies conducted nation-wide between April and December 2007 in outpatient practices, patients with diabetes newly instructed on how to use the pen were interviewed by their trainers (physicians, diabetes consultants) after approx. 6-8 weeks of pen use to give feedback on technical deficiencies, handling problems with the pen, injection habits, as well as on pen properties. Trainers were also asked to assess pen properties and particularly to document the time required for pen training. The evaluation applied a grading system similar to that used in German schools (1: very good; 6: very insufficient/failed). Furthermore, trainers were asked to retrospectively record any adverse events occurring during the observational period.
  
  
  RESULTS
  A total of 2,412 trainers from 1,626 centres and 8,428 patients (80% type 2) participated in the studies. In each study 0.5% of patients reported 41 and 19 technical problems with the pen, respectively. Similarly 3% of patients from each study reported handling problems. Recommended changes of needles and safety checks of the pen before each injection were performed by 40% and max. 25% of the patients, respectively. The features of the new disposable pen were all rated "very good" to "good" by the majority of patients and trainers. The best rated features were usability, dose adjustment and the low effort for the dose release. Pen training of patients were rated as "very simple" or "simple" by the training staff and average instruction time was reported not to exceed more than 10 minutes for the majority of patients. In 19 patients (0.2%) a total of 34 adverse events were documented.
  
  
  CONCLUSIONS
  The results of these two observational studies showed no relevant technical deficiencies and handling problems associated with the new disposable pen in everyday clinical practice. Ease of use and little time required for pen training may contribute to a high acceptance and satisfaction by the patients and training staff. Injection habits, however, indicated that patients did not well comply with recommendations given for needle changes and safety tests.
authors: mail@steffen-boehler.de
authors: S
authors: S
authors: Böhler
authors: W
authors: W
authors: Landgraf
authors: S A
authors: SA
authors: Schreiber