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Taking people in DenmarkNo phase

Comparing 3-day and 7-day insulin infusion sets in children with type 1 diabetes

Compares skin changes with 3-day and 7-day insulin infusion sets in young people.

Plain-language title generated from the registry record
Registry title: A Trial of Three- and Seven-days Insulin Infusions Set

Key facts

Where
Herlev, DenmarkSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers with type 1 diabetes who use a Medtronic 780G pump with automated insulin delivery.

Age
7 to 18 years
Sex
Boys and girls can both join.
Disease stage
Type 1 diabetes for more than 6 months. Insulin needs above 8 units per day.
Earlier treatment
Currently using, or planning to use, the Medtronic 780G pump with its sensor and automated insulin delivery.

Main reasons for not taking part

  • Cannot read and understand Danish
  • Impaired cognitive development that may make it hard to answer questionnaires in Danish or be reached by phone or videocall

Read by machine on 9 November 2026.

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 7 and 18 years old?

Source: NCT06532461, who can take part

Where in Denmark

  • Steno Diabetes Center CopenhagenHerlev, DenmarkTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Steno Diabetes Center Copenhagen
Trial code
NCT06532461
Record updated
6 August 2024
Original description
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 - HumalogRead full original descriptionShow less

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

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

Inclusion: 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: 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.

ClinicalTrials.gov NCT06532461