NCT06532461Recruiting
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
Source: ClinicalTrials.gov · Last updated 6 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 29 Jul 2024
- Start date
- 20 Jul 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06532461
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 20 Jul 2024 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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
Who the study is looking for
- 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
Age in the registry: 7 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.