NOVA BIOMEDICAL StatStrip 55848 - Real World Evidence Studies

A-36
StatStrip Glucose Hospital Meter
Table A-53: Study Site #1 Breakdown
Departments Patients Enrolled
CVICU 150
MICU 50
OR 368
Total Patient Enrollment 568
The capillary whole blood glucose results were compared
to plasma glucose results obtained from arterial or venous
specimens measured on an IDMS traceable Roche Cobas
Modular P800 hexokinase method (Roche Diagnostics,
Indianapolis, IN).
A.8.2 Real World Evidence Studies
Retrospective studies using real world evidence obtained
from critically ill patients were designed to evaluate the dif-
ferences between specimen types from critically ill patients
with a broad range of complex medical conditions and
treatment regimens to determine if capillary whole blood
testing is acceptable for use in these settings using the
StatStrip system.
Table A-54: Real World Study Site Breakdown
Study Sites Patients Enrolled
Mayo Clinic, MN 2,133
Johns Hopkins Bayview, MD 14,645
Total Patient Enrollment 16,778
Clinical Study #2 was a real world clinical review of 2,133
critical care patients throughout all critical care settings that
had a glucose test performed using a capillary whole blood
specimenobtainedbyngerstickandaplasmaglucose
test performed in the central laboratory within 15 minutes of
StatStrip Glu IFU 1.86 PN55848E EN 510K.indd 36 9/13/18 8:29 AM