Type1 Diabetes Mellitus Clinical Trial
Official title:
Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
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 treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep
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 metabolic control . This study will evaluate whether the automated closed-loop
will facilitate and improve the management of diabetes in youth with a poor metabolic
control.
It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety
and acceptability of the automated closed-loop glucose control (CL) day and night, over 28
days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting
in poorly controlled type 1 diabetes adolescents.
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