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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Navigator®
Navigator®
Placebo
Sponsored by
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®

Eligibility Criteria

8 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Sart Tilman Liège
  • CHU Jean Minjoz
  • CH SUD Francilien
  • University Hospital Grenoble
  • Hopital Edouard Herriot
  • CHU Marseille Hôpitaux Sud
  • Chu Montpellier
  • CHU Hôpital Jeanne d'Arc
  • CHU Nantes
  • Hopital Hotel Dieu
  • CHU La Pitié Salpetrière
  • CHU Robert Debré
  • Hopital Haut Leveque
  • CHU de Reims-Hôpital Américain
  • CHU de Reims-Hôpital Robert debré
  • CHU Rennes
  • Hopital Bellevue
  • CHU Strasbourg
  • CHU Toulouse

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Group1-patient

Group2-diabetologist

Group3-Control

Arm Description

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.

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

Usual follow up with self-monitoring blood glucose.

Outcomes

Primary Outcome Measures

Comparison of HbA1c mean between the 3 groups

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2008
Last Updated
February 8, 2012
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
Abbott
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1. Study Identification

Unique Protocol Identification Number
NCT00726440
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
Abbott

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group1-patient
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group2-diabetologist
Arm Type
Active Comparator
Arm Description
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
Arm Title
Group3-Control
Arm Type
Placebo Comparator
Arm Description
Usual follow up with self-monitoring blood glucose.
Intervention Type
Device
Intervention Name(s)
Navigator®
Intervention Description
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
Intervention Name(s)
Navigator®
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Patients will have their usual follow up with self-monitoring blood glucose
Primary Outcome Measure Information:
Title
Comparison of HbA1c mean between the 3 groups
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Comparison of glucose stability in the 3 groups
Time Frame
inclusion, M3, M6, M9, M12
Title
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Time Frame
study period
Title
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
Title
Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection
Time Frame
inclusion, M3, M6, M9, M12
Title
Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups
Time Frame
inclusion and M12
Title
Comparison of weight, insulin doses, in each group
Time Frame
study period
Title
comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption
Time Frame
study period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Riveline, MD
Organizational Affiliation
CH Sud Francilien
Official's Role
Study Director
Facility Information:
Facility Name
CHU Sart Tilman Liège
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
CHU Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CH SUD Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Marseille Hôpitaux Sud
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hôpital Jeanne d'Arc
City
Nancy
ZIP/Postal Code
54201
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Hotel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
CHU La Pitié Salpetrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
CHU Robert Debré
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU de Reims-Hôpital Américain
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU de Reims-Hôpital Robert debré
City
Reims
ZIP/Postal Code
51100
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Hopital Bellevue
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
22456864
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.
Results Reference
derived

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

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