Accuracy and Reliability of Tempo Pen and Tempo Smart ButtonTM

Background: Understanding the extent and causes of suboptimal insulin dosing is key for the coordinated diabetes management. Integrating the benefits of monitoring, education, and clinical support can facilitate self-care among people with diabetes mellitus. Methods: This study presents the technical aspects and performance tests on Tempo Pen, a new connection-enabled insulin pen available for Humalog (insulin lispro), Basaglar/Abasaglar (insulin glargine), and Lyumjev (ultra-rapid lispro) U100 formulations. Tempo Pen, as part of the connected care system, work with the Tempo Smart ButtonTM (pending CE mark), which captures insulin dosing information and transmits it to mobile applications to display. The Tempo device (Tempo Pen + Tempo Smart ButtonTM) can track the date, time of day, insulin dose, and type of insulin accurately. Results: The pen met the ISO 11608-1:2014 requirements for dose accuracy at all doses and conditions tested, and all results were within the ISO specification limits. Tempo Smart ButtonTM has been found to be compatible with Tempo Pen, and met the acceptance criteria and target k-values for glide force, dose accuracy, and attachment/detachment force testing. It demonstrated >95% dose recording accuracy with 95% confidence, and also met requirements for data transfer after every injection. Battery life of Tempo Smart ButtonTM was found to be at least one year. Conclusions: Tempo device is the first connected system with a smart disposable pen. It accurately captures real-time insulin dosing information which can help patients and healthcare professionals address suboptimal insulin management to reach the desired glycemic goal.