Injecting without pressing a button: An exploratory study of a shield‐triggered injection mechanism

Abstract

AimsTo evaluate the injection success and user perception of a shield‐triggered pen‐injector mechanism.MethodsThe trial (http://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.ResultsInjection 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.ConclusionThis 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.

Analysis of “Laboratory and Benchtop Performance of a Mealtime Insulin Delivery System”

“…[5][6][7][8] New injection mechanisms for prefilled pens are being developed to simplify insulin delivery and improve user experience further. 9 And in a recent editorial in this journal, a strong case was made that new smart pens are likely to be beneficial in improving effective use of insulin. 10 Switching poorly controlled patients with type 2 diabetes from MDI to continuous subcutaneous insulin infusion (CSII) has shown potential to provide benefits in terms of HbA1c reduction and a reduction of total daily insulin dose, but a widespread adoption of insulin pump therapy in this patient collective is hampered by the complexity of the devices with extensive training requirements and a lack of reimbursement.…”