Clinical trial NCT00726440: Are the Continuous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients?
Official title: Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Real Time Continuous Glucose Monitoring System
HbA1c
Navigator®
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2008-08-01
Enrollment: 180
Sex: ALL
Minimum age (years): 8
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 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

Primary outcomes:
measure: Comparison of HbA1c mean between the 3 groups
timeFrame: at 1 year
Secondary outcomes:
measure: Comparison of glucose stability in the 3 groups
timeFrame: inclusion, M3, M6, M9, M12
measure: Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
timeFrame: study period
measure: Frequency of symptomatic benign hypoglycaemic episodes during the week prior to each visit. inclusion and prior to M3, M6, M9, M12
timeFrame: prior to inclusion and prior to M3, M6, M9, M12
measure: Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
timeFrame: inclusion, M3, M6, M9, M12
measure: Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
timeFrame: inclusion and M12
measure: Comparison of weight, insulin doses, in each group
timeFrame: study period
measure: comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption
timeFrame: study period
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: CHU Sart Tilman Liège
city: Besancon
country: France
facility: CHU Jean Minjoz
city: Corbeil Essonnes
country: France
facility: CH SUD Francilien
city: Grenoble
country: France
facility: University Hospital Grenoble
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: CHU Marseille Hôpitaux Sud
city: Montpellier
country: France
facility: Chu Montpellier
city: Nancy
country: France
facility: CHU Hôpital Jeanne d'Arc
city: Nantes
country: France
facility: CHU Nantes
city: Paris
country: France
facility: Hopital Hotel Dieu
city: Paris
country: France
facility: CHU La Pitié Salpetrière
city: Paris
country: France
facility: CHU Robert Debré
city: Pessac
country: France
facility: Hopital Haut Leveque
city: Reims
country: France
facility: CHU de Reims-Hôpital Américain
city: Reims
country: France
facility: CHU de Reims-Hôpital Robert debré
city: Rennes
country: France
facility: CHU Rennes
city: Saint Etienne
country: France
facility: Hopital Bellevue
city: Strasbourg
country: France
facility: CHU Strasbourg
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CH Sud Francilien
name: Jean-Pierre Riveline, MD
role: STUDY_DIRECTOR
References:
citation: 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.