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• High Percentage of Manual Queries
• High Percentage of Subjects with Hypoglycaemic events
• High Percentage of DropOuts
• High Percentage of Subjects with PDs in the Informed Consent Form
• Underrecruitment
• High Percentage of Missing Outcomes/Endpoints
• High Percentage of Lost To Follow-Up
• High Percentage of Missing eCRF Entries
• Long Mean Time for Data Entry
• High Percentage of Subjects with Hyperglycaemic events