title: Evaluation of Intradermal and Subcutaneous Infusion Set Performance Under 24-Hour Basal and Bolus Conditions.
abstract: BACKGROUND
  This study sought to assess the function and delivery reliability of intradermal (ID) infusion sets used with commercial insulin pumps.
  
  
  METHODS
  Healthy subjects (n = 43) were randomized to either ID or subcutaneous (SC) arms, and received basal/bolus placebo delivery for 24 hours. Subjects received 4 of 8 infusion set combinations (ID: microneedle design A or B, with 2 pump brands [Animas or MiniMed]; SC: Teflon Quickset or steel Rapid-D, Animas pump only, with or without overtaping) and were evaluated for pump occlusion alarms, fluid leakage, pain, and tissue tolerability. A novel algorithm was developed to determine flow consistency based on fluid pressure, and the duration and occurrence rate for periods of unalarmed but interrupted flow ("silent occlusions'") were compared.
  
  
  RESULTS
  ID delivery was successfully maintained over the 24-hour infusion period. The number of silent occlusions was lower for ID microneedle cannula design B than A (P < .01) and lower for Rapid-D SC device compared to Quick-set (P = .03). There was no significant difference in the number of occlusion alarms between the ID and SC devices with the Animas pump. However, the pumps tested with ID devices had significantly different alarm rates (MiniMed 29.5%, Animas 0%, P < .001). Leakage and tissue tolerability were comparable across devices.
  
  
  CONCLUSIONS
  The ID infusion set reliably delivered diluent for an extended 24-hour period in healthy subjects and was well tolerated. Silent occlusion flow interruptions could be detected in both ID and SC infusion sets using a proprietary algorithm. This algorithm is a promising method for quantitatively evaluating infusion set flow performance.
authors: BD Technologies, Research Triangle Park, NC, USA MaxPoint Interactive, Morrisville, NC, USA.
authors: Elaine
authors: E
authors: McVey
authors: BD Technologies, Research Triangle Park, NC, USA Parker Hannifin Corporation, Madison, WI, USA.
authors: Steven
authors: S
authors: Keith
authors: BD Technologies, Research Triangle Park, NC, USA.
authors: Joshua K
authors: JK
authors: Herr
authors: BD Technologies, Research Triangle Park, NC, USA.
authors: Diane
authors: D
authors: Sutter
authors: BD Technologies, Research Triangle Park, NC, USA Ron_J_Pettis@bd.com.
authors: Ronald J
authors: RJ
authors: Pettis
mesh_terms: D000293:Adolescent; D000328:Adult; D000465:Algorithms; D056902:Clinical Alarms; D004867:Equipment Design; D004868:Equipment Failure; D005240:Feasibility Studies; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D055104:Infusions, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems / Q000009:adverse effects; D008297:Male; D008422:Materials Testing; D008875:Middle Aged; D009339:Needles; D011312:Pressure; D013997:Time Factors; D055815:Young Adult
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin
keywords: continuous subcutaneous insulin delivery; insulin infusion catheter sets; insulin pump occlusion; intradermal insulin delivery; silent occlusion