Need for Inpatient Glycemic Control
The intensive care units have a very high prevalence of hyperglycemia (> 40%). Additionally, hypoglycemia and glycemic variability are well recognized risk factors. It was not until 2001 that a “landmark” study by Berghe et.al. established the need for tight glycemic control [i.e., normalizing glucose through intensive insulin therapy] in ICUs. Significant reduction in mortality, morbidity (due to sepsis, renal failure, blood transfusion), and length of stay (LoS) savings were observed. Financial savings were estimated at $3,345/patient due to reduced LoS and avoided interventions. However despite protocols calling for tight glycemic control, there was poor compliance due to the existing labor-intensive and sub-par accuracy measurement methods which were typically based on capillary fingerstick sampling and meter/strips. The US Medicare system instituted “no-pay” guidelines for complications that arise from poor glucose control.
Challenges with Sepsis Management
Sepsis (defined as a dysregulated host response to infection that causes life-threatening organ dysfunction) is typically caused by blood-borne infections, which may be bacterial, viral or otherwise. Specifically, upon the earliest suspicion of Sepsis, the blood lactate levels should be assessed as part of the Surviving Sepsis Protocol, which helps to rule out or identify the root cause of a lactate elevation. If lactate is elevated (> 2 mmol/L), it can be due to elevated glucose values (Glucose monitoring would address this), internal bleeding (Hemoglobin would address this), need for resuscitating fluids (Central Venous Oxygen Saturation, ScvO2 would address this), organ failure (rare, but heart monitor can address), and blood infection. The knowledge of the "big four" analytes enables the "race" to administer triple anti-biotic therapy, which is today delayed considerably.
Existing Solutions
Currently, blood glucose monitoring is done using labor intensive fingerstick based meters/strips offered by companies like Roche Diagnostics, Nova Biomedical, and Abbott. Multi-analyte measurements are done using products like the i-Stat which uses single use cartridges or blood gas analyzers based on multi-use cartridges from companies like Radiometer (Danaher), Instrumentation Laboratories and Siemens Healthineers. Not only are blood gas analyzers labor intensive, they also are associated with long turn around times, have high cost, expose the care giver to infectious blood and above all result in substantial blood loss to the patient. Central venous oxygen saturation measurements utilize dedicated central venous catheter based fiber-optic systems from companies like Edwards Lifesciences and ICU Medical, but their use remains restricted.
Thus the CMX 4-plex solution provides a one of its kind system for early glycemic management and early Sepsis diagnosis and treatment that is associated with significant mortality and morbidity reductions.