One-year trial of a remote-controlled implantable insulin infusion system in type I diabetic patients. Point Study Group.

Twenty remote-controlled insulin pumps (Siemens AG) were implanted into insulin-dependent type I diabetic patients for a one-year feasibility trial in four centres. The total observation time was 18.2 patient-years. Three pumps had to be prematurely removed after 101, 141, and 236 days. Patients self-monitored blood glucose levels with a mean of 5.5 (range 1-17) measurements per day. 62.9% of these measurements were in the range 3.33-8.88 mmol/l. 3.25 glucose measurements per patient-month were in the hypoglycaemic range (lower than 2.78 mmol/l) and 2.6 episodes of hypoglycaemia with symptoms were reported per patient-month, of which 0.22 per patient-year required medical attention. The median HbA1c level was 7.6% at baseline (10-90% centile = 5.9-9.1%) and 7.0% at the end of the trial (10-90% centile = 5.7-8.3%) (p less than 0.05). Despite some technical and clinical problems, the pump, when used with a stable insulin preparation, was an effective means of treating insulin-dependent patients.