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Collaboration develops artificial pancreas

Pushing the boundaries of current technologies using an automated closed loop software algorithm, Continuous Glucose Monitor (CGM) and a Continuous Subcutaneous Insulin Infusion (CSII) could help many thousands of diabetes patients around the world lead improved lives by providing an artificial pancreas. Leading product design and development company Triteq, is part of the AP@home collaboration a European research project funded by the European Commission and is responsible for developing the system for Clinical Evaluations across six European sites.

The main objective of the project is to improve how patients manage diabetes in a home environment, by developing an artificial pancreas that allows automated glucose control for patients with insulin treated diabetes.

Earlier this month Triteq's Commercial Director Steve Lane and Project Manager Ian Fowler joined the consortium of academic and industrial partners at the 5th International Conference on Advanced Technologies & Treatments for Diabetes in Barcelona. The conference brought together leading researchers, clinicians and general practitioners from all fields of diabetes, endocrinology and metabolism.

AP@home would allow automated glucose control for people with type 1 insulin treated diabetes. Normally, insulin is given either by manual dose injections (MDI) or via continuous subcutaneous infusion pumps (CSII) based on self-medicated blood glucose (SMBG) readings. However, blood glucose levels can be greatly affected by many factors such as diet, physical activity, illness and stress to name a few, so that it is difficult for patients to manage their insulin needs particularly around meal times and the risk of hypoglycemia overnight, in addition each individual patient has a different tolerance and reaction to varying insulin doses. An advanced AP system that combines a Continuous Glucose Monitor (CGM), an insulin infusion pump (CSII), and an automated closed loop software algorithm that calculates how much insulin to deliver at any time in response to the calculated blood glucose level, could not only improve the quality of life for people with type 1 diabetes, but also reduce the escalating healthcare cost burden.

The cost burden could be addressed by this system as a secondary function/feature is to introduce remote monitoring (for the clinical evaluations), but could be extended to remote treatments i.e. Telemedicine, providing the clinical support infrastructure is in place.

The AP@home consortium brings together world-leading experts in the fields of diabetic medical device development, clinical researchers and modeling & control algorithm experts, including seven academic partners (Universities of Cambridge, Padova, Pavia, University Hospitals of Amsterdam and Montpellier, Medical University Graz, EPF Lausanne) and five industrial partners (Profil Institut für Stoffwechselforschung GmbH, Sensile Medical AG, STMicroelectronics, 4a engineering GmbH, as well as Triteq). The project is funded with a €10.5M grant from the European Commission's Framework Programme 7 as it is now entering its third year of a four year project. The forthcoming months will see Triteq piece together the system component parts, and start the verification activities and regulatory requirements need to meet the required safety cases and performance characteristics to support the first automated clinical evaluations with support from the various institutions.

One of the differing approaches Triteq has taken with this Framework 7 programme is to look at delivering a system that could be commercialized and has ensured the correct methods and processes have been followed such that the step to CE mark and potential 510k Submission would be formalities.

Triteq's Ian Fowler, who has been responsible for the Project Management of AP@home gave a presentation at the Conference, detailing the regulatory approval process and the steps required to obtain approavals of medical devices in Europe and the USA.

Being familiar with the regulatory processes required for medical devices for clinical submissions, CE marking and FDA approvals, Triteq has proven itself to be a valued member of the consortium.

Triteq Ltd

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