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

NCT ID: NCT00726440

Last Updated: 2012-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Navigator®

Intervention Type: DEVICE

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

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

Group Type: ACTIVE_COMPARATOR

Navigator®

Intervention Type: DEVICE

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

Usual follow up with self-monitoring blood glucose.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Patients will have their usual follow up with self-monitoring blood glucose

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Placebo

Patients will have their usual follow up with self-monitoring blood glucose

Intervention Type: DEVICE

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Pierre Riveline, MD

Role: STUDY_DIRECTOR

CH Sud Francilien

Locations

CHU Sart Tilman Liège

Liège, , Belgium

CHU Jean Minjoz

Besançon, Besancon, France

CH SUD Francilien

Corbeil-Essonnes, Corbeil Essonnes, France

University Hospital Grenoble

Grenoble, Grenoble, France

Hopital Edouard Herriot

Lyon, Lyon, France

CHU Marseille Hôpitaux Sud

Marseille, Marseille, France

Chu Montpellier

Montpellier, Montpellier, France

CHU Hôpital Jeanne d'Arc

Nancy, Nancy, France

CHU Nantes

Nantes, Nantes, France

Hopital Hotel Dieu

Paris, Paris, France

Hopital Haut Leveque

Pessac, Pessac, France

CHU Rennes

Rennes, Rennes, France

Hopital Bellevue

Saint-Etienne, Saint Etienne, France

CHU Toulouse

Toulouse, Toulouse, France

CHU La Pitié Salpetrière

Paris, , France

CHU Robert Debré

Paris, , France

CHU de Reims-Hôpital Américain

Reims, , France

CHU de Reims-Hôpital Robert debré

Reims, , France

CHU Strasbourg

Strasbourg, , France

Countries

Belgium; France

References

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.

Reference Type: DERIVED

PMID: 22456864 (View on PubMed)

Other Identifiers

2007-A01022-51

Identifier Type: -

Identifier Source: org_study_id