In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive and display CGM data from a separate subcutaneous glucose sensor, or conventional CSII, and compared glycemic outcomes after 6 months.
The long-term clinical benefit of tight glycemic control in people with diabetes is well known . HbA1c generally assesses the average/long term quality of glycemic control, it has been clearly demonstrated that a target of HbA1c at 7.0% or less has benefits for diabetic patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
115
Minimed paradigm Real Time Sytem
Minimed Paradigm 512/712 Insulin pump
CHU Côte de Nacre
Caen, France
Hôpital Universitaire Debrousse
Lyon, France
Hôpital Sainte Marguerite
Marseille, France
CH La Peyronie
Montpellier, France
Difference in HbA1C From Baseline and 6 Months
Difference in HbA1C from Baseline and 6 Months, HbA1C at 6 months - HbA1C at baseline
Time frame: Baseline and 6 months
Change From Baseline in Mean Blood Glucose Value Calculated From CGMS Recordings.
Difference in mean blood glucose value from Baseline and 6 Months, mean blood glucose value at 6 months - mean blood glucose value at baseline
Time frame: Baseline and 6 months
Change From Baseline in Total Daily Dose (TDD)
Difference in TDD value from Baseline and 6 Months, TDD value at 6 months - TDD value at baseline
Time frame: Baseline and 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
American Memorial Hospital
Reims, France
Hôpital Jeanne D'Arc
Saint-Mandé, France
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
CHU Rangueil
Toulouse, France