A Trial of Three- and Seven-days Insulin Infusions Set

Condition(s) studied

Investigational drug(s) / intervention(s)

Mio Advanced infusions set: Insulin infusionsset fitting Medtronic 780 G insulin pump

Novorapid: Randomized to either Novorapid or Humalog

Extended wear insulin infusion (EWIS): Insulin infusionsset fitting Medtronic 780 G insulin pump

Humalog: Randomized to either Novorapid or Humalog

Study summary

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

Eligibility

Primary outcome measure(s)

• Occurence of hyperchogenicity at last two positions for infusions sets — 2 weeks
  Ultrasound scan of skin area for last two positions

Trial sites (1)

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