Dose Accuracy and Reliability of a Connected Insulin Pen System.

For people with diabetes on insulin injection therapy, insulin pen dose accuracy and reliability are key features. Dose accuracy of the Tempo Pen with attached Tempo Smart Button [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.