{"doc_desc":{"title":"Etude longitudinale sur des patients diab\u00e9tiques de type 2 d\u00e9butant un traitement injectable par ex\u00e9natide ou insuline de patients diab\u00e9tiques de type 2 d\u00e9butant un traitement injectable par ex\u00e9natide ou insuline","idno":"FRESH-PEF67-fr","producers":[{"name":"","affiliation":""}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF67-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"67"},{"agency":"FReSH","code":"FRESH-PEF67"}]},"title":"Etude longitudinale sur des patients diab\u00e9tiques de type 2 d\u00e9butant un traitement injectable par ex\u00e9natide ou insuline de patients diab\u00e9tiques de type 2 d\u00e9butant un traitement injectable par ex\u00e9natide ou insuline","alternate_title":"CHOICE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"LILLY FRANCE","extlink":[{"title":"SIREN","uri":"609849153"}]}]},"distribution_statement":{"contact":[{"name":"","type":"contact"}]},"study_info":{"keywords":[{"keyword":"Diab\u00e8te type 2"},{"keyword":"ex\u00e9natide"},{"keyword":"HbA1c"},{"keyword":"insuline"},{"keyword":"qualit\u00e9 de vie"},{"keyword":"effets ind\u00e9sirables"}],"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":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Estimer la dur\u00e9e sous traitement avant tout changement th\u00e9rapeutique significatif chez des patients diab\u00e9tiques de type 2 d\u00e9butant pour la premi\u00e8re fois un traitement par ex\u00e9natide ou insuline.","abstract":"","coll_dates":[{"start":"2008-01-01","end":"2012-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}},{"name":"Allemagne","abbreviation":"de","extLink":{"vocab":"ISO","vocabURI":"de"}},{"name":"Su\u00e8de","abbreviation":"se","extLink":{"vocab":"ISO","vocabURI":"se"}},{"name":"Danemark","abbreviation":"dk","extLink":{"vocab":"ISO","vocabURI":"dk"}},{"name":"Belgique","abbreviation":"be","extLink":{"vocab":"ISO","vocabURI":"be"}},{"name":"Gr\u00e8ce","abbreviation":"gr","extLink":{"vocab":"ISO","vocabURI":"gr"}}],"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        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Adultes de 18 ans et plus,  - Patients de diab\u00e8te  type 2, n\u2019ayant jamais re\u00e7u d\u2019insuline ou d\u2019ex\u00e9natide et d\u00e9butant un traitement par ex\u00e9natide ou une insulinoth\u00e9rapie, dans le cadre habituel de soins.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','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\r\nConsommation de soins\/services de sant\u00e9\r\nQualit\u00e9 de vie\/sant\u00e9 per\u00e7ue"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"2388 (1114 exenatide, 1274 insulin)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"14-12-2010","lastUpdatedAuto":null,"lastUpdatedManual":"09-01-2013","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-CHOICE"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industrie"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Industrie"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Cahier de recueil des donn\u00e9es et questionnaires","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"France, Allemagne, Su\u00e8de, Danemark, Belgique et Gr\u00e8ce"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"HbA1c, glyc\u00e9mie, bilan lipidique, fonction r\u00e9nale (si disponible)","isDataInBiobank":false,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}