title: Pilot study for assessment of optimal frequency for changing catheters in insulin pump therapy-trouble starts on day 3.
abstract: BACKGROUND
  Continuous subcutaneous insulin infusion (CSII) by means of insulin pump devices is considered to be one of the most optimal therapies to achieve treatment targets in patients with diabetes mellitus. In CSII, the insulin is delivered through Teflon catheters or steel needle infusion sets, which need to be renewed on a regular basis. This pilot study was performed to investigate the optimal change frequency in daily practice and to explore potential problems that may occur when the sets are used for a more prolonged time than the recommended up to 72 hours of usage (Teflon catheters).
  
  
  METHODS
  Twelve patients with type 1 diabetes participated in the trial [age (mean +/- STD): 40.3 +/- 12.6 years, body mass index: 26.2 +/- 3.3 kg/m(2), hemoglobin A1c: 6.7 +/- 0.6%]. They were asked to wear their infusion set (Comfort or Silhouette) for increasing periods of 1, 2, 3, 4, and 5 days. After each use, patients completed standardized questionnaires regarding technical and medical issues associated with infusion set use. A health care professional investigated the infusion sites and infusion sets and completed an "infusion set inspection" questionnaire. Blood glucose was measured and recorded to assess a potential influence of duration of catheter use on glycemic control.
  
  
  RESULTS
  Infusion set and injection site problems (itching, bruising, swelling, and pain) started to occur in measurable amounts on the 3rd day of catheter use, and about 40% of patients reported significant issues when using a catheter for 5 days. In parallel, there was a consistent increase in mean daily blood glucose levels that correlated with the number of days of catheter use (e.g., day 1: 7.5 +/- 3.8 mmol/liter, day 3: 8.4 +/- 4.2 mmol/liter, day 5: 9.0 +/- 4.0 mmol/liter, day 7: 11.6 +/- 2.2 mmol/liter, p < 0.05 vs day 1).
  
  
  CONCLUSIONS
  Using the catheters for 2 days resulted in a safe and well-tolerated therapy. Clinically relevant adverse events started to occur during the 3rd day and their incidence increased constantly with longer use. This was associated with undesired changes in mean glycemic control. Data support the recommendation by the drug and device manufacturers that insulin pump catheters should only be used for 48-72 hours to avoid adverse events and potential metabolic deterioration.
authors.affiliation: IKFE-CRO, Mainz, Germany.
authors.forename: Volkmar
authors.initials: V
authors.lastname: Schmid
authors.forename: Cloth
authors.initials: C
authors.lastname: Hohberg
authors.forename: Marcus
authors.initials: M
authors.lastname: Borchert
authors.forename: Thomas
authors.initials: T
authors.lastname: Forst
authors.forename: Andreas
authors.initials: A
authors.lastname: Pfützner
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis; D015190:Blood Glucose Self-Monitoring; D002404:Catheterization / Q000009:adverse effects*; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems / Q000009:adverse effects*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011138:Polytetrafluoroethylene; D011446:Prospective Studies; D012867:Skin / Q000293:injuries; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D011138:Polytetrafluoroethylene