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Accuracy of a New Patch Pump Based on a Microelectromechanical System (MEMS) Compared to Other Commercially Available Insulin Pumps: Results of the First In Vitro and In Vivo Studies

Background: The JewelPUMP™ (JP) is a new patch pump based on a microelectromechanical system that operates without any plunger. The study aimed to evaluate the infusion accuracy of the JP in vitro and in vivo. Methods: For the in vitro studies, commercially available pumps meeting the ISO standard w...

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Published in:Journal of diabetes science and technology 2014-11, Vol.8 (6), p.1133-1141
Main Authors: Borot, Sophie, Franc, Sylvia, Cristante, Justine, Penfornis, Alfred, Benhamou, Pierre-Yves, Guerci, Bruno, Hanaire, Hélène, Renard, Eric, Reznik, Yves, Simon, Chantal, Charpentier, Guillaume
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Language:English
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Summary:Background: The JewelPUMP™ (JP) is a new patch pump based on a microelectromechanical system that operates without any plunger. The study aimed to evaluate the infusion accuracy of the JP in vitro and in vivo. Methods: For the in vitro studies, commercially available pumps meeting the ISO standard were compared to the JP: the MiniMed® Paradigm® 712 (MP), Accu-Chek® Combo (AC), OmniPod® (OP), Animas® Vibe™ (AN). Pump accuracy was measured over 24 hours using a continuous microweighing method, at 0.1 and 1 IU/h basal rates. The occlusion alarm threshold was measured after a catheter occlusion. The JP, filled with physiological serum, was then tested in 13 patients with type 1 diabetes simultaneously with their own pump for 2 days. The weight difference was used to calculate the infused insulin volume. Results: The JP showed reduced absolute median error rate in vitro over a 15-minute observation window compared to other pumps (1 IU/h): ±1.02% (JP) vs ±1.60% (AN), ±1.66% (AC), ±2.22% (MP), and ±4.63% (OP), P < .0001. But there was no difference over 24 hours. At 0.5 IU/h, the JP was able to detect an occlusion earlier than other pumps: 21 (19; 25) minutes vs 90 (85; 95), 58 (42; 74), and 143 (132; 218) minutes (AN, AC, MP), P < .05 vs AN and MP. In patients, the 24-hour flow error was not significantly different between the JP and usual pumps (–2.2 ± 5.6% vs –0.37 ± 4.0%, P = .25). The JP was found to be easier to wear than conventional pumps. Conclusions: The JP is more precise over a short time period, more sensitive to catheter occlusion, well accepted by patients, and consequently, of potential interest for a closed-loop insulin delivery system.
ISSN:1932-2968
1932-2968
1932-3107
DOI:10.1177/1932296814543946