Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system.

BACKGROUND This article describes two novel and easy approaches for assessing the accuracy of insulin pumps as implemented within the artificial pancreas system. The approaches are illustrated by data testing the OmniPod Insulin Management System at its lowest delivery volume (0.05 U) and at doses of 0.1, 0.2, 1, and 6U. METHOD In method 1, a pipette, digital microscope, and imaging software were used to measure average bolus delivery on a linear scale for multiple volumes. In method 2, a digital microscope and imaging software were used to measure the volume of a spherical bolus of 0.05 U of insulin. RESULTS Bench testing results using the two novel methods demonstrated that the OmniPod is extremely accurate, with a relative error ranging from -0.90% to +0.96% for all measured doses (0.05, 0.1, 0.2, 1, and 6 U). In method 1, at target bolus dose of 0.05 U, the mean delivered dose (± standard deviation) was 0.0497 ± 0.003 U, 0.099 ± 0.005 U at 0.1 U, 0.2 ± <1e-5 U at 0.2 U, 1.001 ± 0.018 U at 1 U, and 6.03 ± 0.04 U at 6 U. In method 2, at target bolus dose of 0.5 ml, the mean delivered dose for both OmniPods was 0.505 ± 0.014. CONCLUSIONS Both methods confirmed a high degree of accuracy for the OmniPod insulin pump. These techniques can be used to estimate delivery volume in other infusion pumps as well.