Feasibility Study Comparing the Accuracy of G5 Mobile vs. Abbott Libre
Research type
Research Study
Full title
Feasibility Study Comparing the Accuracy of G5® Mobile vs. Abbott FreeStyle® Libre Flash Continuous Glucose Monitoring Systems
IRAS ID
207658
Contact name
Eileen Casal
Contact email
Sponsor organisation
Dexcom, Inc.
Duration of Study in the UK
0 years, 3 months, 1 days
Research summary
This is a prospective, non-randomized, single-arm, single center study conducted in the United Kingdom. Following screening, if subjects meet inclusion/exclusion criteria and deemed acceptable for enrollment by the Principal Investigator, subjects will participate in up to 14-days sensor wear period (336 hours + 12), the G5 system will consist of two 7-day sensor wear periods and the Libre System will consist of one 14-day sensor wear period; with a specified visit schedule. Subjects will be asked to refrain from the use of acetaminophen-containing medications for the duration of the study, or to notify the study staff if these medications are required. After training on the Systems using provided training materials (e.g. User Guide, Quick Start Guide, and video tutorial), all sensor insertions will be performed at the clinic by subjects, with observation and assistance by clinical staff, if needed, reflecting real-world practice. Subjects will wear CGM Systems in the abdomen (G5 System) and back of the upper arm (Libre System) following instructions from the prospective System User Guide. Subjects will evaluate the Systems at home and during two clinic sessions. If either of the CGM Systems fails prior to the planned study conclusion (after the initial 12-hour replacement period), subjects are instructed to contact their study staff for further instructions.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/1298
Date of REC Opinion
24 Aug 2016
REC opinion
Further Information Favourable Opinion