Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?

Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?

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.

Inclusion Criteria:

• Type 1 Diabetes for ≥ 12 months or more (including Cpeptide negative secondary diabetes)
• Children between 8 and 18 years old
• Adults between 18 and 60 years old
• Patients treated with basal-bolus insulin regimens, pump or multiple daily injection, only with analogs, for at least 6 months
• Performing at least 2 finger sticks glucose controls per day
• Able and motivated to use the device
• HbA1c ≥ 8% twice with HPLC method(DCA 2000 excluded)
• Written informed consent obtained prior to enrollment in the study

Exclusion Criteria:

• Blindness or impaired vision so the screen cannot be recognized
• Allergy to sensor
• Active proliferative retinopathy not stabilized by laser or vitrectomy occurence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during study
• Treatment with systemic corticosteroid or medication known to influence insulin sensitivity in the 3 months prioir to visit 1
• Pregnancy
• Manifest psychiatric disturbance
• Presence of any conditions (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actuel or anticipated that the investigators feels would compromise the patient safety or limit his/her successful participation in the study.
• Hemoglobinopathy that interfers with HbA1c measurement