StatStrip® Glucose/Ketone

The Most Extensively Studied and Proven Glucose Measurement Technology

In addition to studies submitted to the FDA, 168 other independent studies since 2007—including 53 critical care studies—have found no clinically significant interferences for StatStrip's measurement technology. This is a statement that no other glucose meter manufacturer can make. StatStrip and StatStrip Xpress2 are the world’s most extensively studied and proven glucose test. It has been proven to be safe and effective for use throughout all hospital and professional healthcare settings including critical care.

Only Glucose Meter FDA Cleared for Use With All Patients in All Departments, Including Critically Ill

StatStrip Glucose has been designed specifically to measure and correct for clinical interferences that can be present in critically ill patients. The proof data submitted to the FDA included;

  • 1,698 individual critical care patients from five university medical centres had StatStrip Glucose results paired with an IDMS traceable laboratory glucose reference method.
  • Data from multiple intensive care settings representing 19 complex medical condition categories and 257 subcategories as designated by the World Health Organisation were included.
  • Over 8,000 medications representing 33 parent drug classes and 134 drug subclasses as designated by the Unites States Pharmacopeia were studied for possible clinical interferences; no clinical interferences were observed.

"This device provides an important public health resource for critically ill hospitalised patients, who often have conditions or are taking medications that can cause incorrect blood glucose reading. It is important for manufacturers of glucose meters used in hospitals to design and test their devices for use in all hospitalised patients."1

-Alberto Gutierres, Director of the Office of In Vitro Diagnostics and Radiological Devices, Center for Devices and Radiological Health, FDA

No Known Clinical Interferences

Measures and corrects for errors caused by interferences

StatStrip Glucose Multi-Well technology employs a patented, additional interference test well to measure and correct for electrochemical interferences, including paracetamol, ascorbic acid (vitamin C), uric acid, maltose, galactose, dopamine and n-acetylcysteine.

Measures and corrects for errors caused by abnormal haematocrit levels

Low haematocrit (anaemia) is the leading cause of glucose meter error. The average haematocrit among patients at ICU admission is 33% to 34% and continues to decline during ICU stay.1,2 Low haematocrit levels result in erroneously high glucose results, while high haematocrit levels result in erroneously low glucose results. StatStrip Glucose measures and corrects for the effects of haematocrit throughout the haematocrit range encountered in hospitalised patients.

Glucose errors due to interferences result in insulin dosing errors

Boyd et al. studied the effect of glucose measurement errors on insulin dosing error rates. Glucose errors of 15% resulted in very significant insulin dosing error rates, with two-step or greater errors of insulin dosing occurring more than 5% of the time.3

Measures Ketones     

Blood ketone testing should be performed whenever glucose exceeds 11 mmol/l

The Joint British Diabetes Society (JBDS) recommend that blood ketone testing be performed whenever glucose exceeds 11 mmol/l for rapid detection or prevention of diabetic ketoacidosis (DKA).

Glucose and ketone testing results obtained from capillary samples

Capillary blood samples are not only preferred over urine samples to detect and monitor DKA, they are also easier to obtain and allow for immediate reflex testing of ketones whenever glucose is greater then 14mmol/l.4,5

Blood ketone monitoring reduces costs and ICU length of stay for DKA patients

An ICU study evaluated the effectiveness of blood ketone testing versus urine ketone testing for DKA patients. The blood ketone testing group of patients left the ICU 6.5 hours earlier than the urine ketone testing group. This led to savings of 22 hours of nursing time and 375 laboratory investigations, for a total saving of €2,940.6

Fast, Easy Glucose and Ketone Testing

  • Glucose results in 6 seconds 
  • Ketone results in 10 seconds
  • No dosing errors
  • Simple, colour touchscreen operation
  • No calibration codes
  • Bidirectional wireless meter connectivity

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