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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Device: Navigator®
* Device: Navigator®
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group1-patient<br>The patient will be encouraged to use the Navigator® all the time and to modify his treatment according to the continous blood glucose measurements. The patients will follow an educational process in order to adapt insulin doses according to each sensor data. | Device: Navigator®<br>* 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<br>|
| Active Comparator: Group2-diabetologist<br>The patient will follow the same educational process as group 1 concerning insulin dose adaptation. They will use the continous glucose monitoring device according to the diabetologist's prescription and they will receive precise instructions to make considering results. The duration of the use of the Navigator® will be increased if one of the following criteria is observed at the consultation each 3 months: HbA1c>=7.5% 1 severe hypoglycaemia or more More than 4 benign hypoglycaemia per week According to these criteria, every 3 months, the duration of the use of the monitoring system will be increased as following: step 1: 3 sensors per month step 2: 4 sensors per month step 3: 5 sensors per month step 4: continuous use | Device: Navigator®<br>* 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.<br>|
| Placebo Comparator: Group3-Control<br>Usual follow up with self-monitoring blood glucose. | Device: Placebo<br>* Patients will have their usual follow up with self-monitoring blood glucose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of HbA1c mean between the 3 groups |  | at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of glucose stability in the 3 groups |  | inclusion, M3, M6, M9, M12 | 
| Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period |  | study period | 
| Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12 |  | 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 |  | inclusion, M3, M6, M9, M12 | 
| Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups |  | inclusion and M12 | 
| Comparison of weight, insulin doses, in each group |  | study period | 
| comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption |  | study period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®