Background: This study was designed to validate the use of SoloSTAR (sanofi-aventis Deutschland GmbH, Frankfurt, Germany), a new disposable pen developed for use with insulin glargine by patients with type 1 or type 2 diabetes.
Methods: This single-center, open-label, single-arm, sequential trial enrolled subjects with type 1 or type 2 diabetes, 21-78 years old. After face-to-face training (Part 1) or self-training (Part 2), subjects performed three dose-delivery repetitions into an injection pad using separate pens; pens were weighed before and after each dose delivery. The primary outcome was the proportion of subjects delivering successful doses (target dose, 40 units) with all three repetitions. Secondary outcomes included pen accuracy and precision.
Results: Validation population included 50 (Part 1) and 54 (Part 2) subjects. In Part 1, 100% of the subjects delivered a successful dose on all three repetitions. In Part 2, 98% of subjects delivered a successful dose on all three repetitions, with five cases of dose-delivery failures reported in the study population. The mean dose delivered was 40.2 units (95% confidence interval [CI], 40.1-40.3 units) in Part 1 and 38.0 units (95% CI, 36.7-39.3 units) in Part 2; 99% and 88% of dose repetitions in Parts 1 and 2, respectively, were within 38-42 units. The safety test was successfully performed by 80% (95% CI, 70.2-88.0%) of subjects in Part 1 and 68% (95% CI, 58.1-77.6%) in Part 2.
Conclusions: This study successfully validated the SoloSTAR pen for use by subjects with or without face-to-face training. SoloSTAR was shown to be easy to use, accurate, and precise.