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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1-patient | Active Comparator | 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. |
|
| Group2-diabetologist | Active Comparator | 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:
According to these criteria, every 3 months, the duration of the use of the monitoring system will be increased as following:
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| Group3-Control | Placebo Comparator | Usual follow up with self-monitoring blood glucose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of HbA1c mean between the 3 groups | at 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of glucose stability in the 3 groups | inclusion, M3, M6, M9, M12 | |
| Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period | study period | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Pierre Riveline, MD | CH Sud Francilien | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Sart Tilman Liège | Liège | 4000 | Belgium | |||
| CHU Jean Minjoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22456864 | Derived | 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. |
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| Navigator® | 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. |
|
| Placebo | Device | Patients will have their usual follow up with self-monitoring blood glucose |
|
| 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 |
| Evaluation of the Quality of Life (DQOL and SF36) and patient's satisfaction in the 3 groups | inclusion and 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 |
| Besançon |
| Besancon |
| 25030 |
| France |
| CH SUD Francilien | Corbeil-Essonnes | Corbeil Essonnes | 91100 | France |
| University Hospital Grenoble | Grenoble | Grenoble | 38043 | France |
| Hopital Edouard Herriot | Lyon | Lyon | 69003 | France |
| CHU Marseille Hôpitaux Sud | Marseille | Marseille | 13274 | France |
| Chu Montpellier | Montpellier | Montpellier | 34295 | France |
| CHU Hôpital Jeanne d'Arc | Nancy | Nancy | 54201 | France |
| CHU Nantes | Nantes | Nantes | 44093 | France |
| Hopital Hotel Dieu | Paris | Paris | 75004 | France |
| Hopital Haut Leveque | Pessac | Pessac | 33604 | France |
| CHU Rennes | Rennes | Rennes | 35056 | France |
| Hopital Bellevue | Saint-Etienne | Saint Etienne | 42055 | France |
| CHU Toulouse | Toulouse | Toulouse | 31403 | France |
| CHU La Pitié Salpetrière | Paris | 75013 | France |
| CHU Robert Debré | Paris | 75019 | France |
| CHU de Reims-Hôpital Américain | Reims | 51100 | France |
| CHU de Reims-Hôpital Robert debré | Reims | 51100 | France |
| CHU Strasbourg | Strasbourg | 67091 | France |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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