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Randomized Controlled Trial
. 2018 May;20(5):1140-1147.
doi: 10.1111/dom.13203. Epub 2018 Jan 25.

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

Eric Zijlstra  1 , Hans-Veit Coester  1 , Tim Heise  1 , Leona Plum-Mörschel  2 , Ole Rasmussen  3 , Tord Rikte  4 , Line Kynemund Pedersen  4 , Marianne Qvist  4 , Thomas Sparre  4
Affiliations
Randomized Controlled Trial

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

Eric Zijlstra et al. Diabetes Obes Metab. 2018 May.

Abstract

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.

Keywords: FlexPen; confidence; pain; pen-injector; subcutaneous injections.

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Conflict of interest statement

E.Z. has received travel grants and speaker fees from Dance Biopharm, Novo Nordisk and Roche Diabetes Care. T.H. is shareholder of Profil, a private research institute that received research funds from Adocia, Biocon, Dance Pharmaceuticals, Eli Lilly, Johnson & Johnson, Julphar, Medimmune, Mylan, Nordic Bioscience, Novo Nordisk, Poxel, Roche Diagnostics, Saniona, Sanofi, Senseonics, SkyPharma and Zealand Pharma. In addition, T.H. received speaker honoraria from Eli Lilly, Novo Nordisk and Sanofi and fees for the participation in advisory boards from Novo Nordisk. H.‐V.C. has no disclosures to report. L.P.‐M. has received travel grants and speaker fees from Novo Nordisk. O.R., T.S., T.R., M.Q. and L.P. are employees of and hold shares in Novo Nordisk.

Figures

Figure 1
Figure 1
Injection procedure with A, DV3316 and B, FlexPen. DV3316 has a shield concealing the needle. After setting the dose using the dose counter, users are required to press the shield against the skin to trigger the dose delivery mechanism. There is no need to wait after the dose counter has returned to zero. FlexPen users set the required dose using the extending dose button. After inserting the needle into the skin, users are required to fully depress the dose button to deliver the insulin dose and wait for 6 seconds after the “end‐of‐dose” click before withdrawing the needle
Figure 2
Figure 2
A, Subject's confidence in the delivery of a correct dose was assessed after each injection using a scale from 1 to 5, where 1 was ‘not at all confident’ and 5 was ‘extremely confident’. B, assessment of pain with DV3316 and FlexPen. The outer ends of the whiskers of the box plots represent the 10th and the 90th percentiles, respectively, and the dots represent reported visual analogue scale (VAS) scores at each end of the range. Abbreviations: N, number of participants contributing to the evaluation; n, number of injection attempts contributing to the evaluation
See this image and copyright information in PMC

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