Type 1 Diabetes Clinical Trial
Official title:
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.
Status | Completed |
Enrollment | 180 |
Est. completion date | June 2010 |
Est. primary completion date | June 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 60 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Sart Tilman Liège | Liege | |
France | CHU Jean Minjoz | Besancon | |
France | CH SUD Francilien | Corbeil Essonnes | |
France | University Hospital Grenoble | Grenoble | |
France | Hopital Edouard Herriot | Lyon | |
France | CHU Marseille Hôpitaux Sud | Marseille | |
France | Chu Montpellier | Montpellier | |
France | CHU Hôpital Jeanne d'Arc | Nancy | |
France | CHU Nantes | Nantes | |
France | CHU La Pitié Salpetrière | Paris | |
France | CHU Robert Debré | Paris | |
France | Hopital Hotel Dieu | Paris | |
France | Hopital Haut Leveque | Pessac | |
France | CHU de Reims-Hôpital Américain | Reims | |
France | CHU de Reims-Hôpital Robert debré | Reims | |
France | CHU Rennes | Rennes | |
France | Hopital Bellevue | Saint Etienne | |
France | CHU Strasbourg | Strasbourg | |
France | CHU Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète | Abbott |
Belgium, France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of HbA1c mean between the 3 groups | at 1 year | No | |
Secondary | Comparison of glucose stability in the 3 groups | inclusion, M3, M6, M9, M12 | No | |
Secondary | Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period | study period | Yes | |
Secondary | 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 | Yes | |
Secondary | Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection | inclusion, M3, M6, M9, M12 | No | |
Secondary | Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups | inclusion and M12 | No | |
Secondary | Comparison of weight, insulin doses, in each group | study period | No | |
Secondary | comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption | study period | No |
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