Skip to main content
OpenTrials
Completed

NCT Number: NCT00726440

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

8 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Sart Tilman Liège, Liège, Belgium

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Navigator®

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

PLACEBO

Device

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

Primary outcomes

  1. Comparison of HbA1c mean between the 3 groups

    Time frame: at 1 year

Secondary outcomes

  1. Comparison of glucose stability in the 3 groups

    Time frame: inclusion, M3, M6, M9, M12

  2. Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period

    Time frame: study period

  3. 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

  4. Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection

    Time frame: inclusion, M3, M6, M9, M12

  5. Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups

    Time frame: inclusion and M12

  6. Comparison of weight, insulin doses, in each group

    Time frame: study period

  7. comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption

    Time frame: study period

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Abbott

Registry information

Official study title

Are the Continous Glucose Monitoring Systems Able to Improve Long Term Glycaemic Control in Type 1 Diabetic Patients With Poor Metabolic Control?

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 1, 2008
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.