title: Use of an Intravascular Fluorescent Continuous Glucose Sensor in ICU Patients.
abstract: BACKGROUND
  Hyperglycemia and hypoglycemia are associated with adverse clinical outcomes in intensive care patients. In product development studies at 4 ICUs, the safety and performance of an intravascular continuous glucose monitoring (IV-CGM) system was evaluated in 70 postsurgical patients.
  
  
  METHODS
  The GluCath System (GluMetrics, Inc) used a quenched chemical fluorescence mechanism to optically measure blood glucose when deployed via a radial artery catheter or directly into a peripheral vein. Periodic ultrasound assessed blood flow and thrombus formation. Patient glucose levels were managed according to the standard of care and existing protocols at each site. Reference blood samples were acquired hourly and compared against prospectively calibrated sensor results.
  
  
  RESULTS
  In all, 63 arterial sensors and 9 venous sensors were deployed in 70 patients. Arterial sensors did not interfere with invasive blood pressure monitoring, sampling or other aspects of patient care. A majority of venous sensors (66%) exhibited thrombus on ultrasound. In all, 89.4% (1383/1547) of arterial and 72.2% (182/252) of venous measurements met ISO15197:2003 criteria (within 20%), and 72.7% (1124/1547) of arterial and 56.3% (142/252) of venous measurements met CLSI POCT 12-A3 criteria (within 12.5%). The aggregate mean absolute relative difference (MARD) between the sensors and the reference was 9.6% for arterial and 14.2% for venous sensors.
  
  
  CONCLUSIONS
  The GluCath System exhibited acceptable accuracy when deployed in a radial artery for up to 48 hours in ICU patients after elective cardiac surgery. Accuracy of venous deployment was substantially lower with significant rates of intravascular thrombus observed using ultrasound.
authors.affiliation: GluMetrics, Inc, Irvine, CA, USA paul.strasma@gmail.com.
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Strasma
authors.affiliation: Royal North Shore Hospital, Sydney, Australia University of Sydney, Sydney, Australia.
authors.forename: Simon
authors.initials: S
authors.lastname: Finfer
authors.affiliation: Royal North Shore Hospital, Sydney, Australia.
authors.forename: Oliver
authors.initials: O
authors.lastname: Flower
authors.affiliation: Thomas Jefferson University Hospital, Philadelphia, PA, USA.
authors.forename: Brian
authors.initials: B
authors.lastname: Hipszer
authors.affiliation: Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City, Kansas City, MO, USA.
authors.forename: Mikhail
authors.initials: M
authors.lastname: Kosiborod
authors.affiliation: Royal North Shore Hospital, Sydney, Australia.
authors.forename: Lewis
authors.initials: L
authors.lastname: Macken
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Sechterberger
authors.affiliation: Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands TIAS School for Business, Tilburg, Netherlands.
authors.forename: Peter H J
authors.initials: PH
authors.lastname: van der Voort
authors.affiliation: Academic Medical Center, University of Amsterdam, Amsterdam, Netherlands.
authors.forename: J Hans
authors.initials: JH
authors.lastname: DeVries
authors.affiliation: Thomas Jefferson University Hospital, Philadelphia, PA, USA.
authors.forename: Jeffrey I
authors.initials: JI
authors.lastname: Joseph
mesh_terms: D000368:Aged; D001786:Blood Glucose / Q000032:analysis*; D006348:Cardiac Surgical Procedures; D015331:Cohort Studies; D003422:Critical Care; D003920:Diabetes Mellitus / Q000097:blood / Q000175:diagnosis; D005260:Female; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000175:diagnosis*; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis*; D007262:Infusions, Intravenous; D007332:Insulin Infusion Systems; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D008991:Monitoring, Physiologic / Q000295:instrumentation* / Q000379:methods; D011184:Postoperative Period; D013927:Thrombosis / Q000000981:diagnostic imaging; D014463:Ultrasonography
chemical_list: D001786:Blood Glucose
keywords: continuous glucose monitoring; hospital; intensive care; intravascular