Memorandum
ClinicalTrials.gov (Identifier: NCT02336945) is reporting that Abbott has begun recruiting participants for a US pilot study of a professional version of its FreeStyle Libre. The multicenter evaluation (seven centers across the US) will be conducted in adults with type 2 diabetes (estimated enrollment=132) and will assign patients to wear two blinded Libre sensors, one applied to the back of each upper arm, while going about daily activities for a period of 14 days. The primary outcome is the sensor’s glucose variability as measured by Abbott’s Ambulatory Glucose Profile interquartile range, and the study’s estimated date of completion is May 2015. Our understanding is that the study is evaluating Libre’s potential as essentially a professional CGM product – patients would wear the blinded sensor for two weeks allowing providers to get a snapshot of their glucose data. As a reminder, data from the 72-patient, 14-day CE Mark trial of Libre have already been strong and, combined with the initial reception and form factor, have left us enthusiastic about its potential. The company has also begun its US pivotal trial (ClinicalTrials.gov Identifier: NCT02283411) of the sensor at six sites. The study is ongoing (recruitment is complete) and is expected to wrap up in March. Ultimately, it is positive to see Abbott moving ahead on all fronts and we eagerly await topline results.