NCT00726440

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?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète · Academic / Other
• Sex: All
• Age: 8 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Navigator®	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
DEVICE	Navigator®	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.
DEVICE	Placebo	Patients will have their usual follow up with self-monitoring blood glucose

Timeline

• Start date: 2008-02-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2008-08-01
• Last updated: 2012-02-09

Locations

19 sites across 2 countries: Belgium, France