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

July 23, 2008
February 8, 2012
February 2008
June 2010   (final data collection date for primary outcome measure)
Comparison of HbA1c mean between the 3 groups [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00726440 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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?

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type 1 Diabetes
  • 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
  • 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.
    Intervention: Device: Navigator®
  • 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
    Intervention: Device: Navigator®
  • Placebo Comparator: Group3-Control
    Usual follow up with self-monitoring blood glucose.
    Intervention: Device: Placebo
Riveline JP, Schaepelynck P, Chaillous L, Renard E, Sola-Gazagnes A, Penfornis A, Tubiana-Rufi N, Sulmont V, Catargi B, Lukas C, Radermecker RP, Thivolet C, Moreau F, Benhamou PY, Guerci B, Leguerrier AM, Millot L, Sachon C, Charpentier G, Hanaire H; EVADIAC Sensor Study Group. Assessment of patient-led or physician-driven continuous glucose monitoring in patients with poorly controlled type 1 diabetes using basal-bolus insulin regimens: a 1-year multicenter study. Diabetes Care. 2012 May;35(5):965-71. doi: 10.2337/dc11-2021. Epub 2012 Mar 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
8 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
France,   Belgium
 
NCT00726440
2007-A01022-51
No
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Abbott
Study Director: Jean-Pierre Riveline, MD CH Sud Francilien
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP