Status:
COMPLETED
Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?
Lead Sponsor:
Centre Hospitalier du Luxembourg
Collaborating Sponsors:
University of Cambridge
Luxembourg Institute of Health
Conditions:
Type1 Diabetes Mellitus
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief Summary
This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump trea...
Detailed Description
Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metaboli...
Eligibility Criteria
Inclusion
- 12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents
Exclusion
- Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.
- More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months
- \-
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2018
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03300934
Start Date
July 1 2017
End Date
July 19 2018
Last Update
July 31 2018
Active Locations (1)
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1
Clinique des Enfants CHluxembourg
Luxembourg, Luxembourg, 1210