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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:
NCT00726440
First received: July 23, 2008
Last updated: February 8, 2012
Last verified: April 2011
History of Changes
  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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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:

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 ]

Enrollment: 180
Study Start Date: February 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group1-patient
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
Active Comparator: Group2-diabetologist

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.
Placebo Comparator: Group3-Control
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 Jean Minjoz
Besancon, France, 25030
CH SUD Francilien
Corbeil Essonnes, France, 91100
University Hospital Grenoble
Grenoble, France, 38043
Hopital Edouard Herriot
Lyon, France, 69003
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
CHU La Pitié Salpetrière
Paris, France, 75013
CHU Robert Debré
Paris, France, 75019
Hopital Hotel Dieu
Paris, France, 75004
Hopital Haut Leveque
Pessac, France, 33604
CHU de Reims-Hôpital Américain
Reims, France, 51100
CHU de Reims-Hôpital Robert debré
Reims, France, 51100
CHU Rennes
Rennes, France, 35056
Hopital Bellevue
Saint Etienne, France, 42055
CHU Strasbourg
Strasbourg, France, 67091
CHU Toulouse
Toulouse, France, 31403
Sponsors and Collaborators
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Abbott
Investigators
Study Director: Jean-Pierre Riveline, MD CH Sud Francilien
  More Information

No publications provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier: NCT00726440     History of Changes
Other Study ID Numbers: 2007-A01022-51
Study First Received: July 23, 2008
Last Updated: February 8, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 13, 2013