Dose Accuracy and Reliability of a Connected Insulin Pen System.

Abstract

For people with diabetes on insulin injection therapy, insulin pen dose accuracy and reliability are key features. Dose accuracy of the Tempo Pen^TM with attached Tempo Smart Button^TM [Module] (the system) was tested for three doses under standard atmospheric conditions. Reliability and the ability of the Module to detect, store, and transmit dose-related data were also tested. The system met the International Organization for Standardization 11608-1:2014 requirements for dose accuracy at all doses. Mean (standard deviation) doses were 0.010 mL (0.002), 0.299 mL (0.002), and 0.597 mL (0.004) for the 0.010-mL, 0.300-mL, and 0.600-mL doses, respectively. The Module also met requirements for data transfer after every injection. The system accurately delivered doses and reliably captured and stored insulin dosing information.