Dosing accuracy of commonly used disposable insulin pens

Abstract

Objective:

The present study aimed to assess the dosing accuracy of commonly used disposable insulin pens including SoloStar (SR)^*, FlexPen (FP)^†, Next Generation FlexPen (NGFP)^†, and KwikPen (KP)^‡. It is the first comparative study covering the whole dosing range from 1 U to 60 U. It also covers the accuracy of SR at 80 U.

* SoloStar (SR) is a registered trademark of sanofi-aventis.

† FlexPen (FP) and Next Generation FlexPen (NGFP) are registered trademarks of Novo Nordisk A/S.

‡ KwikPen (KP) is a registered trademark of Eli Lilly.

Research design and method:

A total of sixty insulin pens from two lots of each pen type were used. From each pen 1 U, 10 U, 30 U, 40 U, 60 U and 80 U were dispensed in random order. The 80 U dose was only evaluated for the SR as the other insulin pens do not deliver this dose in one injection. The actual doses were determined gravimetrically taking density of the different insulin preparations into account. The evaluation of dose accuracy was based on the regulations of the International Organization for Standardization (DIN EN ISO 11608-1:2000).

Results:

All tested insulin pens met the requirements for accuracy with none of the single values at all dose levels being outside the defined range of the ISO recommendations (1 ± 1 U, 10 ± 1 U, 30 ± 1.5 U, 40 ± 2 U, 60 ± 3 U and 80 ± 4 U). For the investigated dosage levels the absolute average deviation of all insulin pens ranged between 0.09 and 0.81 U.

Conclusion:

The present study demonstrates an excellent dosing accuracy for all tested insulin pens, with no clinically relevant differences between the products.

Key words::

• Diabetes
• DIN EN ISO 11608-1:2000
• Dosing accuracy
• Insulin
• Pre-filled disposable pens

Transparency

Declaration of funding

This study was sponsored by sanofi-aventis Deutschland GmbH.

Declaration of financial/other relationships

T.v.B. has disclosed that he is employed at sanofi-aventis and was involved in the design of the present study.

Some peer reviewers receive honoraria from CMRO for their review work. The peer reviewers of this paper have disclosed that they have no relevant financial relationships.

Acknowledgments

M.K., M.S.-Z. and M.A.-T. were responsible for the study’s performance and evaluation. U.F. was responsible for its statistical evaluation.

The authors have disclosed that they had no outside editorial assistance in preparing this manuscript.

The results of this study were presented in poster form at the CODHy World Congress on Controversies to Consensus in Diabetes, Obesity and Hypertension in Barcelona, Spain, October 30 – November 2, 2008.

Notes

* SoloStar (SR) is a registered trademark of sanofi-aventis.

† FlexPen (FP) and Next Generation FlexPen (NGFP) are registered trademarks of Novo Nordisk A/S.

‡ KwikPen (KP) is a registered trademark of Eli Lilly.

* SoloStar (SR) is a registered trade mark of sanofi-aventis.

†FlexPen (FP) and Next Generation FlexPen (NGFP) are registered trade marks of Novo Nordisk A/S.

‡KwikPen (KP) is a registered trade mark of Eli Lilly.