Clinical Trial

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

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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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-07-31.
Trial Details
NCT Number NCT06532461
Lead Sponsor Steno Diabetes Center Copenhagen
Conditions Type 1 Diabetes
Enrollment 80 participants
Start Date 2024-07-20
Primary Completion 2026-12-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-08-06