Insulin delivery by implanted pumps: one-year trial with programmable infusion systems (the Point Study).

A feasibility trial was carried out in four European centers to test the safety and efficacy of stabilized insulin (HOE 21GH) in twenty remote-controlled infusion pumps (Siemens AG) implanted in twenty type I diabetic patients. Fifteen had been implanted with intraperitoneal and five with the intravenous access route. Total observation time was 18.2 patient years. A total of 36,077 self blood glucose measurements were collected from the patients. Of these 62.9% were in the acceptable range of 70-160 mg/dl. Symptomatic hypoglycemias were rare and reported in a frequency of 2.6 per patient months; of these 0.22 per patient year required medical attention. The median of HbA1c was in the upper normal range or slightly above. Three pumps had to be explanted prematurely because of surgical and technical problems. Although some technical and clinical problems were still observed, the study shows the successful clinical use of implanted, remote-controlled dosing devices and the special insulin preparation stabilized with polyethylene-polypropylene-glycol.