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A Trial of Three- and Seven-days Insulin Infusions Set
Sponsor: Steno Diabetes Center Copenhagen
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
Official title: A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes
Key Details
Gender
All
Age Range
7 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-07-20
Completion Date
2026-12-31
Last Updated
2024-08-06
Healthy Volunteers
No
Conditions
Interventions
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
Locations (1)
Steno Diabetes Center Copenhagen
Herlev, Capital, Denmark