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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726440
• Other study ID #: 2007-A01022-51
• Status: Completed
• Phase: N/A
• First received: July 23, 2008
• Last updated: February 8, 2012
• Start date: February 2008
• Est. completion date: June 2010

Study information

• Verified date: April 2011
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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
• 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.
• Placebo
Patients will have their usual follow up with self-monitoring blood glucose

Locations

Country	Name	City	State
Belgium	CHU Sart Tilman Liège	Liege
France	CHU Jean Minjoz	Besancon
France	CH SUD Francilien	Corbeil Essonnes
France	University Hospital Grenoble	Grenoble
France	Hopital Edouard Herriot	Lyon
France	CHU Marseille Hôpitaux Sud	Marseille
France	Chu Montpellier	Montpellier
France	CHU Hôpital Jeanne d'Arc	Nancy
France	CHU Nantes	Nantes
France	CHU La Pitié Salpetrière	Paris
France	CHU Robert Debré	Paris
France	Hopital Hotel Dieu	Paris
France	Hopital Haut Leveque	Pessac
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

Sponsors (2)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète	Abbott

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of HbA1c mean between the 3 groups		at 1 year	No
Secondary	Comparison of glucose stability in the 3 groups		inclusion, M3, M6, M9, M12	No
Secondary	Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period		study period	Yes
Secondary	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	Yes
Secondary	Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection		inclusion, M3, M6, M9, M12	No
Secondary	Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups		inclusion and M12	No
Secondary	Comparison of weight, insulin doses, in each group		study period	No
Secondary	comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption		study period	No