RecruitingNot ApplicableNCT06532461

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

Sponsor

Steno Diabetes Center Copenhagen

Enrollment

80 participants

Start Date

Jul 20, 2024

Study Type

INTERVENTIONAL

Conditions

Type 1 Diabetes

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

Eligibility

Min Age: 7 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two schedules for changing insulin pump infusion sets (the small needle and tubing that delivers insulin under the skin) in children and teenagers with Type 1 diabetes using an automated insulin system. Currently, sets are typically changed every 3 days. This study asks: is changing them every 7 days safe and does it affect blood sugar control? The goal is to reduce the burden of frequent set changes for young patients. **You may be eligible if...** - You have Type 1 diabetes diagnosed more than 6 months ago - You are between 7 and 18 years old - You use or plan to use the Medtronic 780G hybrid closed-loop insulin pump with its paired sensor - You need more than 8 units of insulin per day **You may NOT be eligible if...** - You cannot read or understand Danish - You have a cognitive impairment that would make it hard to complete questionnaires or participate by phone or video call Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMio Advanced infusions set

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUGNovorapid

Randomized to either Novorapid or Humalog

DEVICEExtended wear insulin infusion (EWIS)

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUGHumalog

Randomized to either Novorapid or Humalog

Locations(1)

Steno Diabetes Center Copenhagen

Herlev, Capital, Denmark

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NCT06532461

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