{"doc_desc":{"title":"Cohort of Elderly Patients with T2D. Comparing the Risk of Hypoglycaemia in DPP4-Inhibitors (iDPP4) with Conventional Oral Antidiabetic Drugs as Add-On Therapy to Metformin.","idno":"FRESH-PEF73265-en","producers":[{"name":"Sylvie DEJAGER","affiliation":"NOVARTIS PHARMA SAS"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73265-en","IDno":{"metadata_no":[{"agency":"PEF","code":"73265"},{"agency":"FReSH","code":"FRESH-PEF73265"}]},"title":"Cohort of Elderly Patients with T2D. Comparing the Risk of Hypoglycaemia in DPP4-Inhibitors (iDPP4) with Conventional Oral Antidiabetic Drugs as Add-On Therapy to Metformin.","alternate_title":"HYPOCRAS"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Isabelle;BOURDEL-MARCHASSON","PILabo":"Bordeaux University Hospital","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"059620641","role":"pi id"},{"title":"SIREN","uri":"263305823","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"Isabelle.bourdel-marchasson@chu-bordeaux.fr","isContact":"Yes"},{"type":"investigator","name":"Alfred;PENFORNIS","PILabo":"Jean-Minjoz Hospital \/ EA 3920","affiliationName":"CHU BESANCON (CHU)","extlink":[{"title":"ORCID","uri":"0000-0002-9635-7674","role":"pi id"},{"title":"IdRef","uri":"034191720","role":"pi id"},{"title":"SIREN","uri":"262501760","role":"organisation 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Patients who had at least two follow-up visits planned over the next 6 months (\u00b1 1 month, 3 months, 6 months \u00b1 1 month).\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through independent healthcare practitioners']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1,317"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"","conditions":"Contact the principal investigator","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"09-11-2015","lastUpdatedAuto":null,"lastUpdatedManual":"20-06-2016","isContributorPI":"No","contributorName":"Sylvie DEJAGER","contributorAffiliation":"NOVARTIS PHARMA SAS","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"","link":"http:\/\/www.diabet-metabolism.com\/article\/S1262-3636%2812%2971192-8\/abstract"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Industry"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)","Industry","Public (France)"],"otherSponsorType":["","",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"By general practitioners","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"France"},"dataTypes":{"clinicalDataDetails":"Details of disease, treatment, hypoglycaemic episodes and glycated haemoglobin (HbA1c) level. 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