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.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Navigator®; Device: Navigator®; Device: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • CHU Sart Tilman Liege
• France
  • Besancon, France, 25030
    • CHU Jean Minjoz
  • Corbeil Essonnes, France, 91100
    • CH Sud Francilien
  • Grenoble, France, 38043
    • University Hospital Grenoble
  • Lyon, France, 69003
    • Hôpital Edouard Herriot
  • Marseille, France, 13274
    • CHU Marseille Hôpitaux Sud
  • Montpellier, France, 34295
    • CHU Montpellier
  • Nancy, France, 54201
    • CHU Hôpital Jeanne d'Arc
  • Nantes, France, 44093
    • CHU Nantes
  • Paris, France, 75004
    • Hôpital Hôtel Dieu
  • Paris, France, 75019
    • CHU Robert Debré
  • Paris, France, 75013
    • Chu La Pitie Salpetriere
  • Pessac, France, 33604
    • Hôpital Haut Levêque
  • Reims, France, 51100
    • CHU de Reims-Hôpital Américain
  • Reims, France, 51100
    • CHU de Reims-Hopital Robert Debre
  • Rennes, France, 35056
    • CHU Rennes
  • Saint Etienne, France, 42055
    • Hôpital Bellevue
  • Strasbourg, France, 67091
    • CHU Strasbourg
  • Toulouse, France, 31403
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of HbA1c mean between the 3 groups	at 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period	study period
Comparison of glucose stability in the 3 groups	inclusion, M3, M6, M9, M12
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
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection	inclusion, M3, M6, M9, M12
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups	inclusion and M12
Comparison of weight, insulin doses, in each group	study period
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption	study period

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Collaborators: Abbott
• Investigators: Study Director: Jean-Pierre Riveline, MD, CH Sud Francilien

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: July 23, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (Estimate): August 1, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: HbA1c; Type 1 Diabetes; Real Time Continuous Glucose Monitoring System; Navigator®
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2007-A01022-51