CM's technology platform is first being applied to the automated measurement of blood glucose in hospitalized patients to support tight glycemic control. The system performs automated/on-demand blood glucose monitoring in a safe, efficient and cost effective manner. The Automated Glucose Monitoring System (AGMS) is comprised of:
- An Instrument Module, that consists of a pump, a pinch valve, circuitry and a touch screen tablet to control the device as well as display the glucose readings; and
- A Disposable Kit (life of ≥ 3-days), that consists of patient-dedicated micro-bore tubing, a specialized zero-dead volume luer adapter, an electrochemical flow-through glucose sensor, and saline based fluid bags for flushing and calibration.
Operation: Following an automated priming routine, the microbore tubing is connected to a conventional catheter (which could be a Peripheral IV, PICC, Central Venous, or Arterial). At the touch of a button, the system automatically calibrates the sensor, pulls blood (~ 0.5 ml) across the sensor for glucose measurement, and then re-infuses all of the blood safely back into the patient. Not a single drop of blood is wasted. Each automated measurement cycle (of calibration, sampling/measurement and reinfusion) takes about a minute and the cycle is repeated at clinician-defined intervals. Between each measurement, the system performs a slow saline infusion into the subject to keep the lines open.
Through the user interface, audible and visual alarms are set and trends are continuously displayed or instantly recalled. All measurement data can also be uploaded to the hospital’s electronic medical record system. A fully functional prototype device is shown.
Performance Validation: The CM system uses the same conventional electrochemical glucose sensor technology that is proven as safe, effective, and accurate in multiple products used in the hospitals for manual blood glucose testing. In in-vitro unprocessed whole blood studies, the system has demonstrated accuracy on par with lab analyzers. The system performance has also been demonstrated in pig and rodent models by tethering to a central catheter over an 8 hour period. Additional longer term preclinical studies are currently underway to support a US FDA Investigational Device Exemption (IDE) application.
CM expects to obtain EU CE mark first to launch in select geographies. An FDA 510k application supported with trials in US hospitals is expected to be filed thereafter.
CAUTION: Investigational device, limited by federal law to investigational use.