Novel Single-Site Device for Conjoined Glucose Sensing and Insulin Infusion: Performance Evaluation in Diabetes Patients During Home-Use.

Goal: This study evaluated a novel diabetes treatment device that combines commercially available continuous glucose monitoring and insulin infusion technology in such a way as to perform insulin delivery and glucose sensing through a single skin insertion site (single-port device). Methods: Ten type 1 diabetes patients used the device for up to 6 days in their home/work environment for open-loop insulin delivery and glucose sensing. On an additional day the device was used in combination with an algorithm to perform automated closed-loop glucose control under hospital settings. To assess the performance of the device, capillary blood glucose concentrations were frequently determined and a continuous glucose sensor was additionally worn by the patients. Results: The average mean absolute relative deviation (mean ARD) from blood glucose concentrations obtained for the sensor of the device was low (median 13.0%; interquartile range 10.5 - 16.7%; n=10) and did not differ from that of the additionally worn glucose sensor (vs. 13.9%; 11.9 - 15.3%; P=0.922). Furthermore, insulin delivery with the single-port device was reliable and safe during home use and, when performed in combination with the control algorithm, was adequate to achieve and maintain near normoglycemia. Conclusion: Our data show the feasibility of open- and closed-loop glucose control in diabetes patients using a device that combines insulin delivery and glucose sensing at a single tissue site. Significance: The reduction in device size and invasiveness achieved by this design may largely increase patient convenience and enhance acceptance of diabetes treatment with continuous glucose monitoring and insulin delivery technology.