Insulin delivery by implanted pumps: one-year trial with programmable infusion systems (the Point Study). 1989

H Walter
IIIrd Medical Department, City Hospital Munich, FRG.

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.

UI MeSH Term Description Entries
D007332 Insulin Infusion Systems Portable or implantable devices for infusion of insulin. Includes open-loop systems which may be patient-operated or controlled by a pre-set program and are designed for constant delivery of small quantities of insulin, increased during food ingestion, and closed-loop systems which deliver quantities of insulin automatically based on an electronic glucose sensor. Pancreas, Artificial Endocrine,Programmable Implantable Insulin Pump,beta Cell, Artificial,Implantable Programmable Insulin Pump,Insulin Pump, Programmable Implantable,Pump, Programmable Implantable Insulin,Artificial Endocrine Pancreas,Artificial beta Cell,Artificial beta Cells,Cell, Artificial beta,Cells, Artificial beta,Endocrine Pancreas, Artificial,Infusion System, Insulin,Infusion Systems, Insulin,Insulin Infusion System,System, Insulin Infusion,Systems, Insulin Infusion,beta Cells, Artificial
D008297 Male Males
D003922 Diabetes Mellitus, Type 1 A subtype of DIABETES MELLITUS that is characterized by INSULIN deficiency. It is manifested by the sudden onset of severe HYPERGLYCEMIA, rapid progression to DIABETIC KETOACIDOSIS, and DEATH unless treated with insulin. The disease may occur at any age, but is most common in childhood or adolescence. Diabetes Mellitus, Brittle,Diabetes Mellitus, Insulin-Dependent,Diabetes Mellitus, Juvenile-Onset,Diabetes Mellitus, Ketosis-Prone,Diabetes Mellitus, Sudden-Onset,Diabetes, Autoimmune,IDDM,Autoimmune Diabetes,Diabetes Mellitus, Insulin-Dependent, 1,Diabetes Mellitus, Type I,Insulin-Dependent Diabetes Mellitus 1,Juvenile-Onset Diabetes,Type 1 Diabetes,Type 1 Diabetes Mellitus,Brittle Diabetes Mellitus,Diabetes Mellitus, Insulin Dependent,Diabetes Mellitus, Juvenile Onset,Diabetes Mellitus, Ketosis Prone,Diabetes Mellitus, Sudden Onset,Diabetes, Juvenile-Onset,Diabetes, Type 1,Insulin Dependent Diabetes Mellitus 1,Insulin-Dependent Diabetes Mellitus,Juvenile Onset Diabetes,Juvenile-Onset Diabetes Mellitus,Ketosis-Prone Diabetes Mellitus,Sudden-Onset Diabetes Mellitus
D005240 Feasibility Studies Studies to determine the advantages or disadvantages, practicability, or capability of accomplishing a projected plan, study, or project. Feasibility Study,Studies, Feasibility,Study, Feasibility
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D015337 Multicenter Studies as Topic Works about controlled studies which are planned and carried out by several cooperating institutions to assess certain variables and outcomes in specific patient populations, for example, a multicenter study of congenital anomalies in children. Multicenter Trials,Multicentre Studies as Topic,Multicentre Trials,Multicenter Trial,Multicentre Trial,Trial, Multicenter,Trial, Multicentre,Trials, Multicenter,Trials, Multicentre
D015918 Infusion Pumps, Implantable Implanted fluid propulsion systems with self-contained power source for providing long-term controlled-rate delivery of drugs such as chemotherapeutic agents or analgesics. Delivery rate may be externally controlled or osmotically or peristatically controlled with the aid of transcutaneous monitoring. Drug Delivery Systems, Implantable,Implantable Infusion Pumps,Perfusion Pumps, Implantable,Peristaltic Pumps, Implantable,Programmable Implantable Medication Systems,Implantable Medication Systems, Programmable,Medication Systems, Programmable Implantable,Systems, Programmable Implantable Medication,Implantable Infusion Pump,Implantable Perfusion Pump,Implantable Perfusion Pumps,Implantable Peristaltic Pump,Implantable Peristaltic Pumps,Infusion Pump, Implantable,Perfusion Pump, Implantable,Peristaltic Pump, Implantable,Pump, Implantable Infusion,Pump, Implantable Perfusion,Pump, Implantable Peristaltic,Pumps, Implantable Infusion,Pumps, Implantable Perfusion,Pumps, Implantable Peristaltic

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