Sylvain Girardot1,2,3, Pauline Jacquemier1,2,3, Flavien Mousin1, Carine Rendekeu1, Sébastien Hardy1, Jean-Pierre Riveline2,3,4. 1. Air Liquide SA, Explor Center (Healthcare), Paris, Île-de-France, France. 2. IMMEDIAB Lab UMRS1138, Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, France. 3. Université Paris Diderot-Paris VII, Paris, France. 4. Department of Diabetes and Endocrinology, Lariboisière Hospital, APHP, Paris, France.
Abstract
Background and Aims: Continuous subcutaneous insulin infusion (CSII) is a widely adopted treatment for type 1 diabetes and is a component of an artificial pancreas. CSII accuracy is essential for glycemic control, however, this metric has not been given sufficient study, especially at the range of the lowest basal rates (BRs), which are commonly used in a pediatric population and in closed-loop systems (CLSs). Our study presents accuracy results of four off-the-shelf CSII systems using a new accurate method for CSII system evaluation. Materials and Methods: The accuracy of four off-the-shelf CSII systems was assessed: Medtronic MiniMed 640G®, Ypsomed YpsoPump®, Insulet Omnipod®, and Tandem t:slim X2®. The assessment was performed using a double-measurement approach through a direct mass flow meter and a time-stamped microgravimetric test bench combined with a Kalman mathematical filter. CSII accuracy was evaluated using mean of dose error. Mean absolute relative difference (MARD) of error was calculated at different observation windows over the whole series of tests. Peakwise insulin deliverance was assessed regarding stroke regularity in terms of frequency and volume. Results: Mean error values indicate a general tendency to underdeliver with up to -16%. MARD of error shows very wide results for each pump and each BR from 7.4% (2 UI/h) to 61.3% (0.1 UI/h). Peakwise analysis shows several choices for BR adaptation (frequency for Omnipod, volume for Tandem, both for YpsoPump and MiniMed 640G). Precision in interstroke time appears to be better (standard deviation [SD] at 0.1 UI/h: 4.6%-12.9%) than stroke volume precision (SD at 0.1 UI/h 38.3%-46.4%). Conclusions: The accuracy of four off-the-shelf CSII systems is model and BR dependent. CSII imprecision could be due to a variability in volume and/or frequency of strokes for every pump. Some models appear better adapted for the smallest insulin needs, or for inclusion in a CLS. The clinical implications of these delivery errors on glucose instability must be evaluated.
Background and Aims: Continuous subcutaneous insulin infusion (CSII) is a widely adopted treatment for type 1 diabetes and is a component of an artificial pancreas. CSII accuracy is essential for glycemic control, however, this metric has not been given sufficient study, especially at the range of the lowest basal rates (BRs), which are commonly used in a pediatric population and in closed-loop systems (CLSs). Our study presents accuracy results of four off-the-shelf CSII systems using a new accurate method for CSII system evaluation. Materials and Methods: The accuracy of four off-the-shelf CSII systems was assessed: Medtronic MiniMed 640G®, Ypsomed YpsoPump®, Insulet Omnipod®, and Tandem t:slim X2®. The assessment was performed using a double-measurement approach through a direct mass flow meter and a time-stamped microgravimetric test bench combined with a Kalman mathematical filter. CSII accuracy was evaluated using mean of dose error. Mean absolute relative difference (MARD) of error was calculated at different observation windows over the whole series of tests. Peakwise insulin deliverance was assessed regarding stroke regularity in terms of frequency and volume. Results: Mean error values indicate a general tendency to underdeliver with up to -16%. MARD of error shows very wide results for each pump and each BR from 7.4% (2 UI/h) to 61.3% (0.1 UI/h). Peakwise analysis shows several choices for BR adaptation (frequency for Omnipod, volume for Tandem, both for YpsoPump and MiniMed 640G). Precision in interstroke time appears to be better (standard deviation [SD] at 0.1 UI/h: 4.6%-12.9%) than stroke volume precision (SD at 0.1 UI/h 38.3%-46.4%). Conclusions: The accuracy of four off-the-shelf CSII systems is model and BR dependent. CSII imprecision could be due to a variability in volume and/or frequency of strokes for every pump. Some models appear better adapted for the smallest insulin needs, or for inclusion in a CLS. The clinical implications of these delivery errors on glucose instability must be evaluated.
Entities:
Keywords:
Artificial pancreas; Insulin pump; Performance; Precision; Test bench; Type 1 diabetes