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

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