Accuracy of a New Patch Pump Based on a Microelectromechanical System (MEMS) Compared to Other Commercially Available Insulin Pumps

Abstract

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. Keywords catheter occlusion, continuous subcutaneous insulin infusion (CSII), insulin delivery accuracy, insulin pump, insulin therapy, microelectromechanical system (MEMS), patch pump, type 1 diabetes

Insulin Micropump with Embedded Pressure Sensors for Failure Detection and Delivery of Accurate Monitoring

“…Switching from multiple daily infusion (MDI) to continuous subcutaneous insulin infusion (CSII) induces well-known advantages, including the reduction of swings in blood glucose levels and the limitation of severe hypoglycemia [5][6][7]. In addition, this MEMS-based micropump provides outstanding delivery accuracy and failure detection capabilities, as reported in recent in vitro and in vivo studies comparing the pumping capability of several pump systems [8]. In this paper, the emphasis is placed on the description of the integrated pressure sensors and their typical experimental responses in various conditions.…”

Comparison of different insulin pump makes under routine care conditions in adults with Type 1 diabetes

“…Median (interquartile range (IQR)) age at the start of pump use was 40 (30, 49) years and median diabetes duration was 20 (11,29) years. Initial pump models were: 50% Medtronic, 24% Omnipod (patch pump), 14% Roche and 12% Animas.…”

“…In particular, Jahn et al showed that the accuracy of the patch pump was lower than that of traditional pumps. In another study by Borot et al, the Omnipod pump was again the least accurate of the pumps tested [11]. However, there has been criticism of the methods used in the studies [16].…”

“…Two reports have suggested lower dose accuracy for the Omnipod insulin pump compared with traditional pumps [10] and to another patch pump [11]. By contrast, inaccuracy in basal insulin delivery has been reported with the movement of conventional pumps in relation to the catheter (pumping upwards and downwards) due to a siphon, whereas the Omnipod performed better [12].…”

Development of a Low-Cost Insulin Infusion Pump: Lessons Learned from an Industry Case

“…We also are analyzing the certification requirements established by ANVISA (Brazilian agency of health surveillance). The accuracy of insulin pumps is of great concern, especially in cases with low infusion rates, where they can limit glycemic variability and unexplained hypo-or hyperglycemic events unawares [8]. So, the next step of the prototype development will start with in vitro studies, using a continuous microweighing method to measure water delivery, and evaluate the accuracy of our prototype.…”