Actively Recruiting

Phase Not Applicable
Age: 7Years - 18Years
All Genders
NCT06532461

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

Led by Steno Diabetes Center Copenhagen · Updated on 2024-08-06

80

Participants Needed

1

Research Sites

127 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 7Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Type 1 Diabetes
  • Diabetes duration of more than 6 months prior to inclusion
  • Currently using the Medtronic 780G pump and sensor with automated insulin delivery or planning to use it
  • Aged between 7 and 18 years before inclusion
  • Insulin needs over 8 units per day
Not Eligible

You will not qualify if you...

  • Unable to read and understand Danish
  • Cognitive impairments that affect answering questionnaires or participating in phone or video calls

AI-Screening

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Trial Site Locations

Total: 1 location

1

Steno Diabetes Center Copenhagen

Herlev, Capital, Denmark, 2730

Actively Recruiting

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Research Team

J

Jannet Svensson, Professor

CONTACT

J

Julian Bjerrekær, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

4

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