Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens

Abstract

Background: Improved patient comfort and optimal glycemic control have led to the widespread use of insulin pens, particularly in Europe. Most of the former studies on the dose accuracy of insulin pens included only a small number of doses and pens. In extension to our previous large-scale study testing the dosing accuracy following a randomized dosing sequence with each pen, the present study was more directed toward the dose accuracy for one specific dose dispensed repeatedly with the same pen. This is the first study providing detailed comparative data on the accuracy of repeated dose delivery with prefilled disposable insulin pens at low, middle, and high doses, dispensed over the entire pen volume. Results: All tested insulin pens met the requirements for accuracy with none of the single values being outside the defined range of the ISO recommendations (1 -1 units, 30 -1.5 units, and 60 -3 units, respectively). Conclusion:The present study demonstrated a consistent and accurate dose delivery at all dosage levels for all tested insulin pens, with no clinically relevant differences among the products.

Dosing Accuracy and Insulin Flow Rate Characteristics of a New Disposable Insulin Pen, FlexTouch, Compared with SoloSTAR

“…Differences between the average values of the actual dose from the target dose were statistically significant at the maximum dose in favor of SS. Consequently, this study confirms the results of previous studies indicating high dosing accuracy for the SS 4,12,13 and disproves former studies reporting single doses outside ISO limits. 6,7,11 Moreover, it demonstrates that the springloaded mechanism of the FT does not translate into a dose accuracy advantage compared with the manually operated SS, even though this might not have been the primary objective for the FT mode of mechanism.…”

“…4 Because of the simplicity and ease of use of these devices, the conversion from the vial and syringe delivery to insulin pens is generally associated with improved medication adherence and reduced likelihood of experiencing hypoglycemic events. 4,5 Previous studies verified the accurate dosing of existing insulin pens, 4,[6][7][8][9][10][11][12][13] although single doses outside the limits specified by the International Organization for Standardization standard (DIN EN ISO 11608-1:2000) 14 have been reported in some small-scale studies. 6,7,11 The existing pen options have been extended by the introduction of the FlexTouch ® (FT; Novo Nordisk; insulin aspart), a prefilled insulin pen with a spring-loaded mechanism.…”

Production and manufacturing of biosimilar insulins: implications for patients, physicians, and health care systems

“…57,58 Various disposable and reusable pens have recently been studied in this respect, and it has been reported that the administration devices that deliver insulin copies showed different performance characteristics compared with the originator devices. [59][60][61][62] For example, Friedrichs et al most recently reported that injection forces with copy insulin pens available in India were significantly higher than those for original insulin devices, 63 a physical difference that could lead to a potentially different patient experience.…”

Dialing Torque Preferences of People with Diabetes When Using Insulin Pens: A Pilot Study

“…The growing popularity of insulin pen devices has led to a number of studies on their usage. Certain technical aspects of insulin pens—such as injection force [5–9] and dose accuracy [4, 5, 7, 8, 10–13]—are thoroughly studied, but there is a paucity of data on the dialing torque required for setting a dose.…”