The PRECISE (European) Trial¹
Performed over 180 days at 7 clinical sites in Europe, it studied a group of 71 adults with Type 1 and Type 2 diabetes using the Eversense CGM System at home and in the clinic. CGM accuracy was assessed during 8 in-clinic visits. The primary safety outcome was device-related serious adverse events. This trial also included a psychosocial sub-study to explore key issues including impact of device on perceptions of diabetes self-management and diabetes control.²
A1C improved in the study group from 7.54% (59 mmol/mol) at baseline to 7.19% (55 mmol/mol) at end of study. Device use coincided with a significant reduction in A1C within a short period of time.
IMPROVEMENT ACROSS SUBJECTS REGARDLESS OF BASELINE A1C
Post study HbA1c levels across all subjects reduced by 0.5% (SD=0.6%, p=0.03)
Post study analysis of subjects with HbA1c>7.5% (n=23) showed significant reduction of 0.7% (p<0.01)
Participants used the CGM for >23 hours per day over the full study duration. No device- or procedure-related serious adverse events were reported with the insertion, use and removal of 147 glucose sensors in 71 participants.
The psychosocial study results also indicated high device acceptance, with 84% rating “I would want to be inserted with a sensor again,” 90% rating “Using the system helped minimize the burden of diabetes in my life,” and a score of 5 or higher (range 1–7) on the CGM Impact Scale. Participants reported improvements on all domains of the Diabetes Distress Scale, and the device was positively associated with psychosocial functioning and quality of life.³
The advanced sensor technology and under-the-skin sensor help patients reach unprecedented levels of wear time, leading to improved clinical outcomes.