{"doc_desc":{"title":"Etude transversale sur des patients diab\u00e9tiques de type 2 : modalit\u00e9s d'\u00e9ducation lors de l'initiation d'une insulinoth\u00e9rapie en m\u00e9decine g\u00e9n\u00e9rale","idno":"FRESH-PEF84-fr","producers":[{"name":"Franck VIGNAL","affiliation":"SANOFI (FRANCE)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF84-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"84"},{"agency":"FReSH","code":"FRESH-PEF84"}]},"title":"Etude transversale sur des patients diab\u00e9tiques de type 2 : modalit\u00e9s d'\u00e9ducation lors de l'initiation d'une insulinoth\u00e9rapie en m\u00e9decine g\u00e9n\u00e9rale","alternate_title":"EDITH"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Franck;VIGNAL","firstname":"Franck","lastname":"VIGNAL","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02n6c9837","role":"organisation id"},{"title":"SIREN","uri":"395030844","role":"organisation 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g\u00e9n\u00e9rale","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2008-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n     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trait\u00e9 par antidiab\u00e9tiques oraux \u00e0 dose maximale (ou dose maximale tol\u00e9r\u00e9e le cas \u00e9ch\u00e9ant), ayant n\u00e9cessit\u00e9 l\u2019adjonction d\u2019une insuline basale initi\u00e9e depuis au minimum 1 mois et au maximum 6 mois (+ 1 semaine) avant l\u2019inclusion, revus 1 mois apr\u00e8s l\u2019initiation \u00e0 l\u2019insuline, lors d\u2019une visite de routine entrant dans le cadre du suivi de son diab\u00e8te, acceptant de participer \u00e0 l\u2019\u00e9tude apr\u00e8s information par le m\u00e9decin observateur.\",\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 evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9"}]},"method":{"data_collection":{"time_method":"Etude transversale non 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