997-P: Testing a Novel Infusion Set for Extended Wear Duration

2020 
This was a randomized double blinded study of a novel infusion set with and without heparin, hypothesizing that small doses of heparin would decrease thrombosis and subcutaneous inflammation. The MiniMed™ Quick-set™ infusion set was modified with a new tubing connector from current P-Cap. The P-Cap was modified to contain a foam (F) or a foam with heparin (F+H) connector. Visibly the sets appeared identical. Each participant wore two F and two F + H sets for 7 days or until set failure. The order of infusion set wear was randomly assigned. Infusion set failure was determined by unexplained hyperglycemia >250mg/dL with a failed correction dose, ketones >0.6mmol/L, evidence of infection, occlusion alarms, or adhesive failure. Infused set survival was compared to similar published 1-week studies using standard Quick-sets. There were 20 participants (mean age 29.5±8 years). Each set was worn 40 times. Length of wear and causes of failure are shown below. Length of wear was not different between the F and F+H groups, but both had improved length of wear compared to historical Quick-sets (p There was no difference in overall duration of wear between the F and F+H groups. Both infusion set groups intended for extended wear had significantly better survival than the historical Quick-Set™ group. Further studies are planned with the F group. Disclosure B.A. Buckingham: Advisory Panel; Self; ConvaTec Inc., Medtronic. Research Support; Self; Beta Bionics, Inc., Dexcom, Inc., Insulet Corporation, Medtronic, Tandem Diabetes Care. T. Marcal: None. L. Hoffman: None. G. Musolino: None. L. Ekhlaspour: None. G. Zhang: None. S. Chattaraj: Employee; Self; Medtronic. Funding Medtronic Diabetes
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