Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Evaluation of Insuman Implantable 400 IU/ml in Patients With Type 1 Diabetes Treated With the Medtronic MiniMed Implantable Pump System Using Insuplant 400IU/ml
Primary Objective:
To compare Insuman Implantable 400 IU/ml versus Insuplant 400 IU/ml with respect to the pump
refill accuracy during a 4 refill cycle period (i.e. the comparative phase); To assess
efficacy measured by hemoglobin glycosylated (HBA1c) change in Insuman Implantable 400 IU/ml
group versus Insuplant 400 IU/ml group after a 4 refill cycle period (i.e. the comparative
phase).
Secondary Objective:
To assess efficacy, safety, refill accuracy evolution and device interventions during the
open-label treatment period with Insuman To evaluate daily insulin doses To assess
Anti-Insulin Antibodies (ADAs or AIA) levels during all study phases
The study duration will be displayed in 2 parts as follow:
Comparative phase (only French patients): 160 +/- 20 days Open label Insuman Implantable
extension phase (French and European patients): from day 160 up to the grant of Insuman
implantable marketing authorization
;
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