Artificial Pancreas Project

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Product Assessment Platform

Triteq's Product Assessment Platform provides a quick economical route to creating portable medical applications for clinical or research evaluation or as a stepping stone to assess a product principle before committing to full development of a bespoke medical product. The system has been designed to the strict standards required for medical devices and the associated documents and templates can be adapted to fit the requirements of a number of medical device types.

Historical Context

In 2009 Triteq was invited to join the AP@home project, a framework 7 European funded initiative to research the design of an Artificial Pancreas.  Prior work by other partners in the consortium had developed AP algorithms and carried out clinical trials using PC based systems. While these were suitable for a clinical environment their use was restricted, partly due to the complexity and size of the PC. The intention of the AP@home project was to move this research into the home environment, but to achieve this, a portable system was required. It was also important that this could be approved by the regulatory authorities in different countries for home use and away from direct clinical supervision.

For the AP@home project, Triteq have developed a Control Platform which connects to a commercially available Continuous Glucose Monitor and Insulin Pump. The platform is based on an ARM processor and can run the closed loop control algorithms developed by the clinical research partners in the project.

 Platform Philosophy

In designing a flexible platform for the AP@home project Triteq's engineers have developed a multi-purpose system that provides the basis for developing wearable technology for clinical research applications. 

Triteq's purpose was to create a set of common hardware, supported by a flexible software system that could be adapted to a variety of potential clinical applications.  The basic premise of the system is for applications requiring closed loop control, where a bio-physical sensor provides a feedback signal to the system from the element that is being controlled.  In the AP@home project the system is used to control the delivery of Insulin which regulates the body's glucose level and this provides the feedback to the control algorithm.

Control of devices such as pumps, thermal regulation, illumination etc is all possible from the platform providing this input changes the bio-physical parameter being measured. 

 High performance processing

The platform incorporates a high power ARM processor, capable of running advanced control algorithms. Triteq have developed a core operating system for the platform and the system provides a flexible interface for the clinical algorithm. Using an embedded library compiled from the researchers' code, the platform is configured to call these library routines and pass parameters into and out of the control algorithm. This means that the researcher maintains control of the source code protecting the valuable IP that has been developed within this. 

A second processor is used to provide an independent safety system for the operations monitoring the hardware and software operation of the main process and raising appropriate alarms under defined fault conditions.

 

Regulatory Approvals

Design of the platform has been carried out within the ISO13485 standards and the necessary traceability of documentation is managed within Triteq's Quality system.  A series of document templates allows the system to be adapted for new research applications so that future regulatory submission can be carried out. Triteq will openly discuss the documentation behind the AP@home project so that the scope of any new adaptation can be easily seen by the researchers.

Triteq's support on a new project based on the platform will extend to providing regulatory liaison with the UK (European?) authorities on behalf of the client, and seeing the process through to clinical trials of the system.

 

Platform Connectivity

The platform supports a number of industry standard connections, allowing flexibility for connecting to sensors, output devices and monitoring.

 

An inbuilt WiFi provides inter-device or Internet connectivity thereby allowing remote system monitoring and supervision.

 

ANT+ low power radio technology, being integrated into many commercially available low power sensors.  Bluetooth, which gives access to a number of different commercially available systems and devices, including Smartphone and tablet applications.  Each of these can be customised to suit the specific research application.

 

User Interface

The Platform User Interface has been designed to run on a PC. The application allows configuration of the platform as well as live monitoring of the performance. The flexibility of using a PC application means that the application can be readily adapted for different user scenarios, while maintaining a common communication protocol with the platform. The basic function screens for the application include User, Clinician and Technician interface, allocation and logging of patient records and system performance monitoring. Triteq will adapt the user interface to suit any user requirement for the platform.

 

Enclosure

The platform will operate from 4AA batteries and is housed in a custom designed case. This provides a robust housing and also features a number of push button inputs and led indicators. The function of each button and indicator can be customised for a user application. Alternatively Triteq can design a bespoke enclosure for a clinical research project or provide full customisation of the design to suit a particular product requirement.

 

For further information please contact Steve Lane at Triteq on 01488 684554.

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