The "Capteur Evadiac" study group, composed of French and Belgian diabetologists, has designed a 1 year randomized controlled multicenter study in order to define what should be the best clinical way of using continuous glucose monitoring in the long term to improve metabolic control in uncontrolled type 1 diabetes patients.
The primary objective of the study is to determine whether patients with chronically poor glycaemic control as evidenced by HbA1c \>= 8% twice can achieve improved metabolic control using during one year CGM together with educative program about insulin adaptation doses compared to conventional self monitoring finger sticks with educative program about insulin adaptation doses alone.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
180
Patients will be encouraged to use the Navigator® all the time and to modify their treatment according to the device measurments. Patients will also follow and educational process in order to adapt insulin doses according to each sensor data
Patients will follow the same educational process as group1 concerning insulin doses adaptation.The duration of the use of the devicewill be determined at the consultation every each 3 months.
Patients will have their usual follow up with self-monitoring blood glucose
CHU Sart Tilman Liège
Liège, Belgium
CHU Jean Minjoz
Besançon, Besancon, France
Comparison of HbA1c mean between the 3 groups
Time frame: at 1 year
Comparison of glucose stability in the 3 groups
Time frame: inclusion, M3, M6, M9, M12
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Time frame: study period
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12
Time frame: prior to inclusion and prior to M3, M6, M9, M12
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
Time frame: inclusion, M3, M6, M9, M12
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
Time frame: inclusion and M12
Comparison of weight, insulin doses, in each group
Time frame: study period
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption
Time frame: study period
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