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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Navigator®; Device: Placebo

• Registration Number: NCT00726440
• Lead Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-07-23
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2011-04
• Last Update Submitted: 2012-02-08
• Last Update Posted: 2012-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1-patient	Navigator®	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.
Group2-diabetologist	Navigator®	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
Group3-Control	Placebo	Usual follow up with self-monitoring blood glucose.

Primary Outcome Measures

Name	Time	Method
Comparison of HbA1c mean between the 3 groups	at 1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

CH SUD Francilien; 🇫🇷 Corbeil Essonnes, France

CHU Nantes; 🇫🇷 Nantes, France

Hopital Haut Leveque; 🇫🇷 Pessac, France

CHU Robert Debré; 🇫🇷 Paris, France

CHU de Reims-Hôpital Américain; 🇫🇷 Reims, France

CHU de Reims-Hôpital Robert debré; 🇫🇷 Reims, France

CHU Rennes; 🇫🇷 Rennes, France

Hopital Bellevue; 🇫🇷 Saint Etienne, France

CHU Strasbourg; 🇫🇷 Strasbourg, France

CHU Toulouse; 🇫🇷 Toulouse, France

CHU Sart Tilman Liège; 🇧🇪 Liege, Belgium

CHU Jean Minjoz; 🇫🇷 Besancon, France

Chu Montpellier; 🇫🇷 Montpellier, France

CHU Hôpital Jeanne d'Arc; 🇫🇷 Nancy, France

Hopital Hotel Dieu; 🇫🇷 Paris, France

CHU La Pitié Salpetrière; 🇫🇷 Paris, France

Hopital Edouard Herriot; 🇫🇷 Lyon, France

University Hospital Grenoble; 🇫🇷 Grenoble, France

CHU Marseille Hôpitaux Sud; 🇫🇷 Marseille, France