{"doc_desc":{"title":"Etude transversale sur l'intensification de l'insulinoth\u00e9rapie des patients diab\u00e9tiques de type 2 en pratique r\u00e9elle","idno":"FRESH-PEF88-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF88-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"88"},{"agency":"FReSH","code":"FRESH-PEF88"}]},"title":"Etude transversale sur l'intensification de l'insulinoth\u00e9rapie des patients diab\u00e9tiques de type 2 en pratique r\u00e9elle","alternate_title":"INTENSIVE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Franck;VIGNAL","PILabo":"Sanofi Aventis","affiliationName":"SANOFI (FRANCE)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"","uri":"","role":"pi id"},{"title":"SIREN","uri":"395030844","role":"organisation id"},{"title":"","uri":"","role":"labo 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l'insulinoth\u00e9rapie"}],"topics":[{"topic":"Endocrinologie","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/d1dd1bac-5313-4ab3-837f-4acd3ec521a7"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D004704"}]},{"topic":"Diab\u00e8te sucr\u00e9 de type 2","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/119724091","title":"CIM-11"}]}],"purpose":"D\u00e9crire l\u2019\u00e9volution de l\u2019HbA1c \u00e0 6 mois sous diff\u00e9rentes strat\u00e9gies th\u00e9rapeutiques d\u2019intensification de l\u2019insulinoth\u00e9rapie utilis\u00e9es chez des patients diab\u00e9tiques de type 2 trait\u00e9s par l\u2019association d\u2019antidiab\u00e9tiques oraux et d\u2019insuline basale n\u00e9cessitant l\u2019adjonction d\u2019insuline 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   {\n            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"homme ou femme, \u00e2g\u00e9(e) de plus de 18 ans, pr\u00e9sentant un diab\u00e8te de type 2 r\u00e9pondant aux crit\u00e8res de l\u2019HAS : trait\u00e9 par l\u2019association d\u2019antidiab\u00e9tiques oraux et d\u2019insuline basale (semi lente ou lente) et n\u00e9cessitant l\u2019adjonction d\u2019une insuline rapide.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary 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