Status:
UNKNOWN
Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study
Lead Sponsor:
ISIS Diabete Service
Conditions:
Diabetes Mellitus, Type 1
Pediatric ALL
Eligibility:
All Genders
12-17 years
Phase:
NA
Brief Summary
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion). Several studies showed that despite a patients' follow-up mostly by hospital-based paediatr...
Detailed Description
As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the in...
Eligibility Criteria
Inclusion
- Children (\<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII.
- Children for whom it is the first initiation of CSII.
- Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.
Exclusion
- Children with a history of diabetes less than 12 months.
- Children with HbA1c values below 7.5 or above 10 before CSII initiation.
- Children treated by CSII for more than 3 months.
Key Trial Info
Start Date :
September 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04100070
Start Date
September 2 2019
End Date
December 31 2021
Last Update
December 4 2020
Active Locations (1)
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1
Isis Diabete Service
Gennevilliers, Île-de-France Region, France