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 (known by glucose monitoring), internal bleeding (known by Hemoglobin monitoring), need for resuscitating fluids (known by Central Venous Oxygen Saturation), organ failure (known by cardiac monitoring), and blood infection. The knowledge of the "big four" analytes enables the "race" to administer triple anti-biotic therapy, which is today delayed considerably.
Shortcomings of Existing Solutions
Blood glucose monitoring is currently done using labor intensive fingerstick based meters/strips offered by companies like Roche Diagnostics, Nova Biomedical, and Abbott or by interstitial fluid based continuous glucose monitoring systems from companies like Medtronic and Dexcom - which are known of have sub-optimal accuracy in critical care. Multi-analyte measurements are typically done using point-of-care instruments like the Abbott i-Stat and the Siemens epoc which use single use cartridges. Alternatively, they are performed using blood gas analyzers with a multi-use cartridge from companies like Radiometer (Danaher), Instrumentation Laboratories (Werfen). 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.
The CMX Solution: AutoPlexer
Other Blood Analytes: CMX plans to add other time sensitive tests to the AutoSampler platform. Whole blood sensors to monitor blood gases, electrolytes and multiple other biomarkers will be integrated to the plataform. Combining leading edge innovations in micro-fluidics, electro-chemistry, and machine intelligence, CMX has developed patentable inventions covering technologies, designs, and other relevant operational aspects.
Critical Care Stats in the US and a visual illustration of the AutoPlexer is provided below.
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