Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Real Time Continuous Glucose Monitoring System, HbA1c, Navigator®
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.
Interventions
DEVICENavigator®
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
DEVICEPlacebo
Patients will have their usual follow up with self-monitoring blood glucose
Sponsors
Abbott
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of HbA1c mean between the 3 groups | at 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period | study period |
| 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 |
| Comparison of HbA1c in patients treated by pump to those treated by multiple daily injection | inclusion, M3, M6, M9, M12 |
| Comparison of glucose stability in the 3 groups | inclusion, M3, M6, M9, M12 |
| Comparison of weight, insulin doses, in each group | study period |
| comparison of the sensors consumption in group 1 and 2 and the evolution in time of this consumption | study period |
| Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups | inclusion and M12 |
Countries
Belgium, France
Outcome results
None listed