Clinical Need: Critically ill patients undergoing intensive medical treatment often develop insulin resistance associated with hyperglycemia (elevated blood glucose levels) even if they have no previous history of diabetes. Hyperglycemia in hospitalized patient slows healing, prolongs length of stay, increases costs and contributes to a high incidence of morbidity and mortality. Maintaining normoglycemia in these intensive care settings is associated with significantly better clinical outcomes and reduced length of stay. The foundation of tight glycemic control that is achieved through intensive insulin therapy demands frequent blood glucose monitoring. Here is what the key opinion leaders in this space have to say about the need for automated glucose monitoring.
The current protocols for blood glucose testing utilize frequent finger-sticks which are labor intensive, painful, costly, error-prone, and expose the caregiver to potentially infectious blood. More importantly, the overworked nurses are not able to adhere to the tight testing schedules required to maintain normoglycemia. Tests are often missed or delayed and the insulin is not adjusted timely enough to prevent episodes of hypoglycemia, a condition that can result in neurological impairment and/or death. Automating the current blood sampling, measurement and/or control process (see figure) will allow nurses to use this crucial time for other care and quality initiatives.
Furthermore, medical experts recommend that inpatient glucose measurement be ideally made in vascular derived samples (venous/arterial) as opposed to capillary blood (from finger-sticks) or interstitial fluid (from subcutaneous implants), given the patient's reduced peripheral blood flow and abnormal physiological status.
Market Estimates: Of the 5 million ICU admissions annually in the US, nearly half of them experience hyperglycemia as a complication of their treatment. According to industry estimates, each conventional finger-stick glucose test costs a hospital approximately $10-$20 of which 80% is labor. By automating manual testing, the market is expected to well exceed $1B as labor costs are transferred to the automated testing equipment.
Medicare, the US government health service for seniors, has even instituted “no-pay” guidelines for complications associated with out-of-control glucose [CMS-1390-F]. As a consequence, 82% of hospitals in the US have now adopted intensive insulin therapy (IIT) protocols, up from 28% in 2006. However, few hospitals are able to comply with the protocol mandates because of the intense nurse labor required and the inadequacy of the current manual measurement tools. It may also be mentioned here that, notwithstanding the strong evidence in favor of maintaining tight glycemic control in ICUs, there have been certain recent randomized studies of intensive insulin therapy that have reported inconsistent effects on mortality and significantly increased rates of severe hypoglycemia. The key reasons identified for these inconsistencies relates to the challenge of implementing the intervention needed to maintain tight control and the poor accuracy of the strip-based capillary blood glucose measurements. For the lack of resources and tools, the study sponsors recommended relaxed glycemic control targets rather than risk hypoglycemic events.
Cascade Metrix is working to bring products to market to address this clinical opportunity. Winning in the marketplace will much depend on the test accuracy, reliability, robustness, and price. CM believes its system can achieve the winning balance of these critical features.