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

Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Navigator®; Device: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00726440

2007-A01022-51

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 patients

Sex: All

Ages: 8 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 3 patient groups, including a placebo group

Group1-patient

Active Comparator group

Description:

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.

Treatment:

Device: Navigator®

Device: Navigator®

Group2-diabetologist

Active Comparator group

Description:

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

Treatment:

Device: Navigator®

Device: Navigator®

Group3-Control

Placebo Comparator group

Description:

Usual follow up with self-monitoring blood glucose.

Treatment:

Device: Placebo