title: Feasibility of intraperitoneal insulin therapy with programmable implantable pumps in IDDM. A multicenter study. The EVADIAC Study Group. Evaluation dans le Diabète du Traitement par Implants Actifs.
abstract: OBJECTIVE
  To report the overall French experience, obtained through the collaboration of seven centers (EVADIAC [Evaluation dans le Diabète du Traitement par Implants Actifs] register), on the safety, feasibility, and efficacy of intraperitoneal insulin therapy by programmable implantable pumps, using three different devices.
  
  
  METHODS
  This is a multicenter prospective study involving 224 type I diabetic patients implanted with a programmable implantable pump (cumulative follow-up: 353 patient-years; mean duration: 1.5 +/- 0.9 years [mean +/- SD]. The Infusaid and the Promedos devices are equipped with a side port and refilled with U100 insulin (Hoechst 21 PH); the Minimed pump is not equipped with a side port and is refilled with U400 insulin (Hoechst 21 PH). Metabolic data and adverse events were recorded in a central register run by EVADIAC.
  
  
  RESULTS
  A total of 29 local pump-pocket events (8/100 patient-years) and 9 pump failures (2.5/100 patient-years) occurred. The major technical problems were 1) pump flow rate reduction related to insulin aggregates, reversible after alkaline rinsing of the pump, and 2) 47 catheter obstructions requiring laparoscopic or conventional surgery. Pump therapy was abandoned in only 11 patients. HbA1c (7.4 +/- 1.8 vs. 6.8 +/- 1.0%, P < 0.001), mean glycemia (8.7 +/- 1.5 vs. 7.8 +/- 1.0 mmol/l, P < 0.001), and blood glucose SDs (3.8 +/- 0.8 vs. 3.3 +/- 0.8 mol/l, P < 0.001) decreased significantly after 6 months and remained lower than baseline thereafter.
  
  
  CONCLUSIONS
  Intraperitoneal insulin infusion using an implantable programmable pump is a feasible and relatively safe technique that may improve metabolic control and glycemic stability. Long-term studies, however, are needed to demonstrate whether or not the improvement in glycemic control could be sustained for several years.
authors.affiliation: Hôpital Rangueil, Toulouse, France.
authors.forename: H
authors.initials: H
authors.lastname: Hanaire-Broutin
authors.forename: C
authors.initials: C
authors.lastname: Broussolle
authors.forename: N
authors.initials: N
authors.lastname: Jeandidier
authors.forename: E
authors.initials: E
authors.lastname: Renard
authors.forename: B
authors.initials: B
authors.lastname: Guerci
authors.forename: M J
authors.initials: MJ
authors.lastname: Haardt
authors.forename: V
authors.initials: V
authors.lastname: Lassmann-Vague
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D001786:Blood Glucose / Q000378:metabolism; D002408:Catheters, Indwelling / Q000009:adverse effects; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000188:drug therapy*; D004867:Equipment Design; D004868:Equipment Failure / Q000706:statistics & numerical data; D005240:Feasibility Studies; D005260:Female; D005602:France; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D011446:Prospective Studies; D012449:Safety
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin