Dose accuracy and durability of a durable insulin pen before and after simulated lifetime use

Abstract

Background and objective:

NovoPen Echo is an insulin pen designed specifically for children and adolescents with diabetes. The pen combines half-unit dosing and a simple memory function that records the size of the last dose and the time in hours that has elapsed since last injection. Durability is an essential feature of durable insulin pens in order to ensure accuracy throughout the lifetime of the pen. This study was designed to assess dose accuracy and durability of NovoPen Echo before and after simulated lifetime use.

*NovoPen Echo is a registered trademark of Novo Nordisk A/S, Bagsvaerd, Denmark.

Research design and methods:

All testing was conducted according to International Organization for Standardization (ISO) guideline 11608-1 for pen injectors. Dose accuracy was measured for the delivery of 0.5 international units (IU) (5 mg), 15 IU (150 mg) and 30 IU (300 mg) test medium before and after lifetime simulation under standard, cool and hot conditions. Functionality tests were also performed under a number of stress conditions including dry heat, cyclical temperature, vibration, free fall and electrostatic discharge.

**1IU for human insulin corresponds to 1U for modern insulin.

Results:

The dose accuracy of NovoPen Echo meets the requirement stated in ISO 11608-1 for all three doses for all tests before and after lifetime simulation. The pens remained intact and retained dosing accuracy at all doses after exposure to variations in temperature and humidity and before and after physical challenge to simulate lifetime use.

Conclusions:

The accuracy of NovoPen Echo was retained under conditions of stress likely to be encountered in everyday use due to its durable design.

Key words::

• Children
• Diabetes
• Dose accuracy
• Durable insulin pens

Transparency

Declaration of funding

This study was carried out by Novo Nordisk A/S, Bagsvaerd, Denmark.

Declaration of financial/other relationships

C.M.K. and S.K.L. are both employees of Novo Nordisk A/S and both have employee shares in Novo Nordisk A/S.

Peer reviewers may receive honoraria from CMRO for their review work. The peer reviewers have disclosed that they have no relevant financial relationships.

Acknowledgements

The authors would like to acknowledge Elena Kozina, Novo Nordisk A/S for assistance with the statistical analysis and valuable input to the manuscript. Editorial support was provided by John Clarke of ESP Bioscience (Crowthorne, UK).

Notes

*NovoPen Echo is a registered trademark of Novo Nordisk A/S, Bagsvaerd, Denmark.

**1IU for human insulin corresponds to 1U for modern insulin.

*NovoPen is a registered trademark of Novo Nordisk A/S, Bagsvaerd, Denmark.

†NovoFine is a registered trademark of Novo Nordisk A/S, Bagsvaerd, Denmark.

*HumaPen Luxura is a registered trademark of Eli Lilly Company, Indianapolis, USA.