Design and Clinical Evaluation of the Interoperable Artificial Pancreas System (iAPS) Smartphone App: Interoperable Components with Modular Design for Progressive Artificial Pancreas Research and Development

摘要

Background: There is an unmet need for a modular artificial pancreas (AP) system for clinical trials within the existing regulatory framework to further AP research projects from both academia and industry. We designed, developed, and tested the interoperable artificial pancreas system (iAPS) smartphone app that can interface wirelessly with leading continuous glucose monitors (CGM), insulin pump devices, and decision-making algorithms while running on an unlocked smartphone. Methods: After algorithm verification, hazard and mitigation analysis, and complete system verification of iAPS, six adults with type 1 diabetes completed 1 week of sensor-augmented pump (SAP) use followed by 48 h of AP use with the iAPS, a Dexcom G5 CGM, and either a Tandem or Insulet insulin pump in an investigational device exemption study. The AP system was challenged by participants performing extensive walking without exercise announcement to the controller, multiple large meals eaten out at restaurants, two overnight periods, and multiple intentional connectivity interruptions. Results: Even with these intentional challenges, comparison of the SAP phase with the AP study showed a trend toward improved time in target glucose range 70–180 mg/dL (78.8% vs. 83.1%; P = 0.31), and a statistically significant reduction in time below 70 mg/dL (6.1% vs. 2.2%; P = 0.03). The iAPS system performed reliably and showed robust connectivity with the peripheral devices (99.8% time connected to CGM and 94.3% time in closed loop) while requiring limited user intervention. Conclusions: The iAPS system was safe and effective in regulating glucose levels under challenging conditions and is suitable for use in unconstrained environments.