Abstract

The objective of AP@home is to build and evaluate an artificial pancreas (AP) with automated closed loop glycaemic control for insulin treated patients with diabetes. AP systems require algorithms using blood glucose levels obtained via glucose monitoring for controlling subcutaneous insulin administration.

First, well established subcutaneous continuous glucose sensors and insulin pumps will be combined to improve and verify the functionality of enhanced closed-loop algorithms. We will advance algorithm quality, improve sensors by bringing their accuracy below the desired 5% error level and add a remote hypoglycaemia alarm. Second, in parallel, two AP systems will be developed by combining an insulin pump and a sensor into a single device, using only one access point through the skin (“single-port”). Thereby the need to puncture the skin twice, once for the glucose sensor and once for the insulin infusion, can be avoided (“two-port”). If proven successful in computer simulations we will evaluate the best selected single-port system under clinical conditions.

Deliverables include: description of more precise glucose sensing methods; description of system integration of the two-port and both single-port AP systems; validation of prototypes in the clinic and at home. In a multinational controlled trial AP performance will be compared with standard intensive insulin therapy in daily life.

Impact of the project includes strengthened competitiveness of European industry across a complete value chain involving large, mid-sized and small companies, enabling Europe to lead progress in AP systems. Also, the project will put European research and clinical organizations in leading positions with an increased number of high-skilled jobs in the medical device industry. Finally, diabetes care will be simplified, quality of life of patients with diabetes will be improved and diabetes related complications and health costs will diminish in the long run.