System for monitoring safety in medication delivery for diabetes management

摘要

An integrated diabetes management (IDM) system includes a safety layer which, in one configuration has two components, one located between a glucose sensor and a controller and a second component located between a controller and a pump, to monitor various aspects of signals and modify those signals for compatibility and safety purposes. In one application, the safety layer receives output control signals from a controller and modifies those control signals as a function of an actual amount of insulin delivered to the user. The safety layer allows for an increased level of safety in the IDM system and permits development of separate hardware and software upgrades with the safety layer assuring that compatibility between components will continue.

主权项

1. An integrated diabetes management system, comprising:
a glucose sensor configured to sense glucose and provide sensor glucose data representative of sensed glucose; a delivery device configured to deliver medication in response to a delivery control signal; a controller programmed to receive the sensor glucose data, to calculate a delivery level of medication based on the received sensor glucose data, and to provide an output control signal as a function of the received sensor glucose data to effect the calculated delivery level of medication; and a safety layer programmed to receive at least one of the sensor glucose data and the output control signal, and to modify at least one of the received sensor glucose data and the output control signal so that at least one of the glucose data would be modified to become modified glucose data and the output control signal would be modified to become a modified output control signal that would be provided as the delivery control signal to achieve the calculated delivery level of medication without reconfiguration of either the glucose sensor or the programming of the controller to calculate the delivery level.