MASA Understand Prove CONFIDENTIAL 1 Communicate Grow Evangelos - PowerPoint PPT Presentation

Ev Evan angelos Nt Ntriv rivalas, M MD, D, P PhD, D, H HCLD/ D/CC(ABB), D( D(ABMLI) Director of Medical & Scientific Affairs Nova Biomedical MASA Understand • Prove • CONFIDENTIAL 1 Communicate • Grow

Evangelos Ntrivalas, MD, PhD, is a paid employee of Nova Biomedical, a designer and manufacturer of whole blood diagnostic technologies. This presentation is intended to be educational and free from commercial content. MASA Understand • Prove • CONFIDENTIAL 2 Communicate • Grow

Discuss the new regulatory requirements for bedside glucose • measuring systems (BGMS) in hospitals Why FDA has new requirements for BGMS testing on critically ill • Glucose meter performance issues created the need for new • FDA regulations Define the problems caused by glucose meter inaccuracy • P resent the clinical evidences supporting the new FDA critical care • clearance What are the restrictions related to “off- label” use of BGMS on • critically ill patients. MASA Understand • Prove • CONFIDENTIAL 3 Communicate • Grow

Glucose meters are used in the management of dysgly glycemia mia (hypog ogycemia ia and hypergly lycemia ia) in the hospital MASA Understand • Prove • CONFIDENTIAL 4 Communicate • Grow

 To accomplish this goal, need to  1) rapidly detect dysglycemia and Glycemic  2) return patient to “normoglycemia ” control is  Frequent measurement of glucose to detect dysglycemia the end goal  Frequency dependent on acuity  Treat acute hyperglycemia with insulin  SQ vs. IV  Treat hypoglycemia with oral nutrition and/or dextrose MASA Understand • Prove • CONFIDENTIAL 5 Communicate • Grow

Settin ting Applic icatio ion Emerge rgency D Depart artment Evaluation of unconscious patient, detection of hyperglycemia, detection of hypoglycemia, evaluation of acid- base disorder etiology (diabetic ketoacidosis) General Medi edical F Floo oor o or U Unit Monitoring of glucose, management of diabetic patients (adjustments of anti - diabetic medications including SQ insulin) Int ntensive Ca Care U Uni nit Frequent monitoring as part of tight glycemic control protocol, detection of stress hyperglycemia, monitoring for hypoglycemia in critically ill non- responsive patients Nursery ry Monitoring and detection of hypoglycemia, monitoring for efficacy of nutritional management MASA Understand • Prove • CONFIDENTIAL 6 Communicate • Grow

 Multiple specimen types  Capillary, venous, and arterial  Low sample volume  Most systems require less than 5 µL of whole blood  Rapid analysis time  Reduced therapeutic turn around time Combined these features allow for frequent serial monitoring of patients with rapid therapeutic turn around time MASA Understand • Prove • CONFIDENTIAL 7 Communicate • Grow

Pre-examination errors (pre-analytical) 1. Examination errors (analytical) 2. Post-examination errors (post-analytical) 3. MASA Understand • Prove • CONFIDENTIAL 8 Communicate • Grow

e.g. Improper sampling, User Error calibration code errors e.g. Altitude, temperature, humidity Endogenous Environmental Glucose Interferences Factors Meter e.g. Hematocrit, hypotension, pH, electrolytes, lipids, PO 2 e.g. Maltose, Exogenous galactose, xylose, ascorbate, Interferences acetaminophen MASA Isbell and Lyon. Glucose meters. Where are we now? Where are we heading? MLO. 2012 Understand • Prove • CONFIDENTIAL 9 Communicate • Grow

Glucose = 54 mg/dL Glucose = 247mg/dL Karon BS et al. Evaluation of the Impact of Hematocrit and Other Interference on the Accuracy of Hospital- Based Glucose Meters. Diabetes Technology & Therapeutics, Vol 10, No 2, 2008. MASA Understand • Prove • CONFIDENTIAL 10 Communicate • Grow

Change in baseline glucose (mmol/L) 1.1 Glucose 68 mg/dL 0.55 0 -0.55 -1.1 MASA Karon BS et al. Evaluation of the Impact of Hematocrit and Other Interference on the Accuracy of Hospital-Based Glucose Meters. Diabetes Technology & Therapeutics, Vol 10, No 2, 2008. Understand • Prove • CONFIDENTIAL 11 Communicate • Grow

CASE REPORT MASA Understand • Prove • CONFIDENTIAL 12 Communicate • Grow

CASE REPORT 54-year-old female History Presented with altered sensorium and drowsiness, • leading to unconsciousness in 1 hr Initial glucose levels checked on glucometer: 187 m 187 mg/dL dL • Past history Diabetic • Chronic kidney disease • MASA IJCRI 2013;4(9):485 -488 Understand • Prove • CONFIDENTIAL 13 Communicate • Grow

CASE REPORT Symptoms and signs at hospital admission Patient unconscious; not responding to deep pain; • flaccid paralysis of all 4 limbs; pupils constricted but reacted to light; depressed deep tendon reflexes; plantar reflexes not elicited Vital signs Normal heart rate (100 bpm) • Blood pressure 110/70 mmHg • Respiratory rate: 18 per minute • Capillary glucose levels checked by glucose meter at • admission: 167 m 167 mg/dL dL MASA IJCRI 2013;4(9):485 -488 Understand • Prove • CONFIDENTIAL 14 Communicate • Grow

CASE REPORT Differential diagnoses Brain stem cerebrovascular accident • Metabolic encephalopathy • Uremic encephalopathy • Brain MRI “ Bilateral symmetrical hyper intense lesions in the internal capsule, corona radiata and centrum semiovale , with reduced apparent diffusion coefficient” MASA IJCRI 2013;4(9):485 -488 Understand • Prove • CONFIDENTIAL 15 Communicate • Grow

CASE REPORT Laboratory results (one hour later) Hemoglobin 8.2 g/ dL ↓ • Hematocrit 20% ↓ • Normal CBC • Normal hepatic enzymes • BUN 96 mg/dL ↑ • Na ++ 132 mEq/L • K + 5.2 mEq/L • Uric acid 9.2 mg/dL ↑ • Plasma glucose 24 m mg/ g/dL dL • MASA IJCRI 2013;4(9):485 -488 Understand • Prove • CONFIDENTIAL 16 Communicate • Grow

CASE REPORT Treatment 25% dextrose and then 500 mL of 10% glucose infusion • Outcome Patient improved dramatically in few minutes; regained • consciousness; moving all four limbs; complete recovery of all neurological deficit Discharge Patient was discharged asymptomatic within 24 hrs with the • diagnosis of hypoglyc ycemic ic encephalo lopathy MASA IJCRI 2013;4(9):485 -488 Understand • Prove • CONFIDENTIAL 17 Communicate • Grow

CASE REPORTS Galactose interference MASA Understand • Prove • CONFIDENTIAL 18 Communicate • Grow

CASE REPORTS Galactose interference Neonate with prolonged jaundice, liver 13-day-old girl • • dysfunction, renal tubular dysfunction Jaundice, hemolytic anemia • POC glucose: > 15mmol/L POC glucose: persistently high • • Treated with insulin Absence of glycosuria • • Condition deteriorated • Plasma glucose results : consis iste tently tly Plasma glucose results: consis iste tently tly • • low low Urine: 4+ galactose High blood galactose level • • Diagnosis: galactosemia Diagnosis: galactosemia • • MASA Understand • Prove • CONFIDENTIAL 19 Communicate • Grow

Glucose Xylose Mannose Lactose Gal Glc Glucosamine Icodextrin Galactose EXTRANEAL Peritoneal Maltose Dialysis Solution A disaccharide composed A branched glucose polymer of two glucose units MASA Understand • Prove • CONFIDENTIAL 20 Communicate • Grow

What l led ed t to the c e change i in regulatory requirements? MASA Understand • Prove • CONFIDENTIAL 21 Communicate • Grow

Implementation of intensive insulin therapy (IIT) and tight • glycemic control (TGC) protocols Erroneous glucose results led to adverse events and deaths • FDA holds open forum: “Public Meeting: Blood Glucose • Meters” (Mar 16,17 2010) FDA issues warning letters about PQQ enzyme POCT systems, • maltose interferences, etc. Community of patients, providers, manufacturers, and • regulators identify the need for improved performance criteria for all glucose meters MASA Understand • Prove • CONFIDENTIAL 22 Communicate • Grow

Inapprop opriat iate Interferences management Inaccu ccurate Advers rse measure reme ment event nt of g of glu lucose For example a falsely high result could lead to over- treatment with insulin or missed detection of hypoglycemia Av Avoidan ance o of an anal alytical erro rrors rs requir ires t technolog ology d desig igned specif ifically ally to eliminate i inter erfer eren ences s seen en o on hospit italiz lized p patients MASA Understand • Prove • CONFIDENTIAL 23 Communicate • Grow

 Serious injuries and deaths reported due to whole blood glucose meters: 100 deaths associated with whole blood glucose • monitoring reported to the FDA (1992- 2009) including hospital deaths attributed to maltose, galactose and ascorbic acid among others 12,672 serious injuries to patients (2004 - 2008) • Interferences were the primary root cause of deaths and • adverse events. MASA FDA/CDRH Public Meeting, 2010 Understand • Prove • CONFIDENTIAL 24 Communicate • Grow