Development of program-controlled portable insulin delivery devices.

Various alternatives for program-controlled insulin delivery systems, on which we have been working since 1972, are described. Fixed-programmable and demand-programmable devices, both in two parts comprising separate control and delivery units, have been miniaturized and technically improved to the extent that they can now be used for the ambulant, long-term treatment of diabetic patients. The electronic drive systems, including control and safety circuits, that are discussed using the demand-type system as an example have been conventionally designed, using CMOS technology. The mechanical components of the insulin-delivery devices, in particular the roller pump driven by a stepping motor, have been developed in such a way that they can also be employed in implantable devices, without any essential modifications. Particular attention was thus paid to the features of miniaturization, high insulin concentration, low energy consumption, and a high degree of safety and reliability. The experience obtained from broad-based clinical trials of the devices is summarized briefly.