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.

Keywords: Tempo Pen; Tempo Smart Button; connected insulin pen; self-management.

Figure 1.

Personalized diabetes management system. (a) Humalog Pen injector operational/mechanical characteristics. (b) Smart Button. (c) Connected care environment.

Figure 2.

Distribution curves of dose accuracy analysis for (a) 0.010 mL, (b) 0.300 mL, and (c) 0.600 mL. The blue lines indicate the International Organization for Standardization specification limits. Abbreviations: LSL, lower specification limit; USL, upper specification limit.

Figure 3.

Histogram showing the data for maximum angle deviation from nominal (a) including all doses and (b) excluding the first dose. The blue line indicates the International Organization for Standardization specification limit. Abbreviation: USL, upper specification limit.