Status:
RECRUITING
A Trial of Three- and Seven-days Insulin Infusions Set
Lead Sponsor:
Steno Diabetes Center Copenhagen
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-18 years
Phase:
NA
Brief 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 insul...
Detailed Description
Background An increasing proportion of patients with diabetes mellitus type 1 (T1D) is using diabetes devices in order to achieve better glycemic control, improved quality of life and more flexible li...
Eligibility Criteria
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
Key Trial Info
Start Date :
July 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06532461
Start Date
July 20 2024
End Date
December 31 2026
Last Update
August 6 2024
Active Locations (1)
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1
Steno Diabetes Center Copenhagen
Herlev, Capital, Denmark, 2730