title: Reduced Silent Occlusions with a Novel Catheter Infusion Set (BD FlowSmart): Results from Two Open-Label Comparative Studies.
abstract: BACKGROUND
  Insulin pump users experience periods of unexplained hyperglycemia. In some cases these may be due to insulin flow interruptions termed "silent occlusions," which occur without activating the pump alarm and may require set replacement.
  
  
  METHODS
  In-line pressure profiles of a novel infusion set with a 6-mm, 28-gauge polymer, dual-ported catheter (BD FlowSmart™; Becton Dickinson and Co., Franklin Lakes, NJ) were compared with those of an existing infusion set (Quick-set®; Medtronic MiniMed, Northridge, CA) in two separate studies involving insulin diluent infusions over 2.5-4.5-h periods in healthy adults without diabetes. Study 1, a pilot study (n = 25), compared the occurrence of flow interruption events (silent occlusions and/or occlusion alarms) between the two infusion sets and between manual or device-assisted insertion methods. Study 2 (n = 60) was designed to show ≥50% reduction in flow interruption events with the BD set after manual insertions. (Silent occlusions were defined by a continuous pressure rise for ≥30 min.)
  
  
  RESULTS
  In Study 1, significantly fewer silent occlusions were seen with BD FlowSmart versus Quick-set infusion sets for both manual (three of 22 [13.6%] vs. 12 of 24 [50%]; P = 0.012) and mechanical (two of 24 [8.3%] vs. nine of 25 [36%]; P = 0.037) insertions, yielding risk reductions of 73% (95% confidence interval [CI], 25-91%) and 77% (95% CI, 17-94%), respectively. In Study 2, flow interruption events occurred in three of 117 (2.6%) and 12 of 118 (10.2%) BD FlowSmart and Quick-set infusion sets, respectively, yielding a 75% risk reduction (95% CI, 20-92%; P = 0.030). Percentage of time with flow interruption was significantly lower with BD sets in both studies (P < 0.02). Leakage (>0.5 IU or 5 μL) occurred infrequently and did not differ between sets.
  
  
  CONCLUSIONS
  A novel side-ported insulin infusion set demonstrated significant reductions in flow interruptions, including silent occlusions, versus a leading marketed set, which may improve insulin delivery.
authors.affiliation: 1 Diabetes Care, BD Medical Affairs, Becton Dickinson and Company , Franklin Lakes, New Jersey.
authors.forename: Michael
authors.initials: M
authors.lastname: Gibney
authors.affiliation: 2 Office of Science, Medicine and Technology, BD Corporate Clinical Development, Becton Dickinson and Company , Sparks, Maryland.
authors.forename: Zhenyi
authors.initials: Z
authors.lastname: Xue
authors.affiliation: 3 Diabetes Care, BD Research & Development, Becton Dickinson and Company , Andover, Massachusetts.
authors.forename: Monica
authors.initials: M
authors.lastname: Swinney
authors.affiliation: 1 Diabetes Care, BD Medical Affairs, Becton Dickinson and Company , Franklin Lakes, New Jersey.|4 School of Pharmacy, MCPHS University , Boston, Massachusetts.
authors.forename: Damian
authors.initials: D
authors.lastname: Bialonczyk
authors.affiliation: 1 Diabetes Care, BD Medical Affairs, Becton Dickinson and Company , Franklin Lakes, New Jersey.
authors.forename: Laurence
authors.initials: L
authors.lastname: Hirsch
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D061807:Catheter Obstruction / Q000009:adverse effects*; D002404:Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000379:methods / Q000451:nursing; D002408:Catheters, Indwelling / Q000009:adverse effects*; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D006801:Humans; D007332:Insulin Infusion Systems / Q000009:adverse effects*; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D009515:New Jersey; D010865:Pilot Projects; D058996:Quality Improvement; D013041:Specialties, Nursing / Q000193:education; D055815:Young Adult