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

Sponsor:	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Collaborators:	AFD Abbott
Information provided by:	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:	NCT00726440

Purpose

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.

Condition	Intervention
Type 1 Diabetes	Device: Navigator® Device: Placebo

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Dextrose

U.S. FDA Resources

Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:

Comparison of HbA1c mean between the 3 groups [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of glucose stability in the 3 groups [ Time Frame: inclusion, M3, M6, M9, M12 ] [ Designated as safety issue: No ]
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period [ Time Frame: study period ] [ Designated as safety issue: Yes ]
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12 [ Time Frame: prior to inclusion and prior to M3, M6, M9, M12 ] [ Designated as safety issue: Yes ]
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection [ Time Frame: inclusion, M3, M6, M9, M12 ] [ Designated as safety issue: No ]
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups [ Time Frame: inclusion and M12 ] [ Designated as safety issue: No ]
Comparison of weight, insulin doses, in each group [ Time Frame: study period ] [ Designated as safety issue: No ]
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption [ Time Frame: study period ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	February 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group1-patient: Active Comparator 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® 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
Group2-diabetologist: Active Comparator 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® 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.
Group3-Control: Placebo Comparator Usual follow up with self-monitoring blood glucose.	Device: Placebo Patients will have their usual follow up with self-monitoring blood glucose

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.

Eligibility

Ages Eligible for Study:	8 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726440

Locations

Belgium
CHU Sart Tilman Liège
LIEGE, Belgium, 4000
France
CHU Strasbourg
Strasbourg, France, 67091
CHU La Pitié Salpetrière
Paris, France, 75013
CHU de Reims-Hôpital Robert debré
Reims, France, 51100
CHU de Reims-Hôpital Américain
Reims, France, 51100
CHU Robert Debré
Paris, France, 75019
CHU Jean Minjoz
Besancon, France, 25030
CH SUD Francilien
Corbeil Essonnes, France, 91100
University Hospital Grenoble
Grenoble, France, 38043
CHU Toulouse
Toulouse, France, 31403
CHU Marseille Hôpitaux Sud
Marseille, France, 13274
Chu Montpellier
Montpellier, France, 34295
CHU Hôpital Jeanne d'Arc
Nancy, France, 54201
CHU Nantes
Nantes, France, 44093
Hopital Hotel Dieu
PARIS, France, 75004
Hopital Haut Leveque
PESSAC, France, 33604
CHU Rennes
Rennes, France, 35056
Hopital Bellevue
Saint Etienne, France, 42055
Hopital Edouard Herriot
Lyon, France, 69003

Sponsors and Collaborators

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

AFD

Abbott

Investigators

Study Director:

Jean-Pierre Riveline, MD

CH Sud Francilien

More Information

No publications provided

Responsible Party:	Centre d'Etudes et de Recharche pour l'Intensification du Traitement du Diabète ( Dr Jean-Pierre RIVELINE / Principal Investigator )
Study ID Numbers:	2007-A01022-51
Study First Received:	July 23, 2008
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00726440 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Type 1 Diabetes
Real Time Continuous Glucose Monitoring System
HbA1c
Navigator®

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010