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Aims To evaluate the injection success and user perception of a shield‐triggered pen‐injector mechanism. Methods The trial ( ClinicalTrials.gov NCT02627287) was an exploratory, two‐centre, one‐visit, open‐label, randomized controlled trial conducted in Germany in 150 injection‐experienced individuals with type 1 or type 2 diabetes. Participants self‐administered subcutaneous injections of a placebo solution using a prototype shield‐triggered pen‐injector, DV3316 (Novo Nordisk, Bagsvaerd, Denmark), and FlexPen (Novo Nordisk, Bagsvaerd, Denmark). Injection success was evaluated on a yes/no basis by the investigator. Participant confidence, leakage of fluid and pain were evaluated after each injection. Pain and device experience were assessed after completion of all injections with each pen‐injector. Overall preference was assessed after completion of all injections with both pen‐injectors. Results Injection success was high with both pen‐injectors (97.0%, DV3316 vs 99.7%, FlexPen). Participant confidence in dose delivery was similar for the two devices (88% of injections with DV3316 vs 81% with FlexPen were scored as “extremely confident”). The median injection pain score on a visual analogue scale (0‐100) was 3 with DV3316 vs 4 with FlexPen after each injection, and 4 with DV3316 vs 5 with FlexPen after all injections with each device. After all injections were completed, 55% of participants reported an overall preference for DV3316 vs 21% for FlexPen. Conclusion This study demonstrates that injection‐experienced individuals can achieve a high injection success rate with a shield‐triggered pen‐injector, with similar patient confidence and injection pain compared with FlexPen.
Zijlstra et al. (Wed,) studied this question.