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

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About this study

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

Condition
Type 1 Diabetes
Tested
Mio Advanced infusions set, Novorapid, Extended wear insulin infusion (EWIS), Humalog
Sponsor
Steno Diabetes Center Copenhagen

Who can join

Age
7 to 18 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 9

  • Minimum age: 7 years
  • Maximum age: 18 years
  • Study condition: Type 1 Diabetes
  • Diagnosed with T1D
  • Diabetes duration of more than 6 months prior to inclusion.
  • Currently using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.
  • Planning to using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.
  • Being between 7 and 18 years of age prior to inclusion
  • Insulin needs per day above 8 units

Exclusion 2

  • Those who are unable to read and understand Danish
  • Those with impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and/or be reached by phone or videocall

Where

1 site, 1 recruiting

Steno Diabetes Center Copenhagen

Herlev, Capital, Denmark

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.