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.
D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D002986:Clinical Trials as Topic; D003258:Consumer Behavior; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006441:Hemoglobin A / Q000032:analysis; D006801:Humans; D007260:Infusion Pumps; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D012648:Self Care
D001786:Blood Glucose; D007328:Insulin; D006441:Hemoglobin A