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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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 Criteria: * 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

Treatments Being Tested

DEVICE

Mio Advanced infusions set

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUG

Novorapid

Randomized to either Novorapid or Humalog

DEVICE

Extended wear insulin infusion (EWIS)

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUG

Humalog

Randomized to either Novorapid or Humalog

Locations (1)

Steno Diabetes Center Copenhagen
Herlev, Capital, Denmark