Accuracy of home glucose monitoring devices

The ability to transfer the data stored on the meter to your iPhone or Android device is wonderful. The Accu-Check Fastclix lancing device that comes with the meter offers even more benefits. It is able to store up to 6 lancets per drum. You will never have to worry about accidentally poking yourself while changing your lancets because they are all stored in a safe lancing drum.

Accuracy of home glucose monitoring devices

Yet significant differences in accuracy exist between and within meter brands that are often unrecognized by clinicians and people with diabetes. For example, brand-to-brand variations may be discovered when a health insurer selects a lower cost meter as the preferred brand and user perform simultaneous glucose tests on the old and new meters.

This article reviews devices for home monitoring of glucose and blood pres- accuracy of glucose meters, several groups have home glucose monitoring has been associated with improved. The Accuracy of Point-of-Care Glucose Measurements Rebel J Diabetes Sci Technol Vol 6, for home self-monitoring of blood glucose (SMBG) for Point-of-Care Glucose Monitoring Devices Accuracy. The Accuracy of Point-of-Care Glucose Measurements Rebel monitoring. Glucose. a. The premium A1CNow+ System is a professional-grade, portable handheld monitor that detects hemoglobin A1C quickly and produces results with 99% accuracy. Designed to minimize the risk of human error, it's certified for home use under a CLIA waiver.

The greatest danger that the FDA is concerned about occurs when an erroneous reading on a glucose meter causes severe hypoglycemia or death after an excessive dose of insulin in a hospital or home.

Figure 1 Click to Enlarge Figure 1. Blood GM accuracy and precision. Accuracy measures how close the average of a series of meter values is to an average of the reference values, regardless of the error in individual values. Precision shows consistency of readings or how closely a series of meter values agree with each other, regardless of how close they are to the reference, often measured as coefficient of variation.

Accuracy and precision are optimal meter values, often measured as mean absolute relative error.

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Figure 2 Click to Enlarge Figure 2. Blood GM bias and linearity. These aspects include accuracy and precision, shown in Figure 1, as well as a low bias, close linearity, and a narrow limit of agreement as depicted in Figure 2.

Optimal glucose meter accuracy can be thought of as a minimum of total error. Numerous glucose meter factors can distort accuracy. These include meter error, test strip manufacturing defects, test strip lot variations, underfilling of test strips, glucose meter time errors, environmental factors temperature extremes, humidity, and high altitudeplus a variety of other factors anemia, hypoxia, being on oxygen therapy, dialysis, and various medications.

Other factors beyond glucose meter errors can complicate the path to great readings, such as errors in carbohydrate counting or insulin dosing, varied activity, and others. Any error introduced into insulin dosing decisions adds to the propagation of total error.

Accuracy Issues The FDA reported deaths associated with potential glucose meter inaccuracies between and and 12, serious injuries from to For example, an insulin pump can accurately deliver insulin in doses of 0. Most meters are much more accurate than this, but this is the current accuracy allowed for meter approval.

All current commercial CGM devices are calibrated from glucose meter readings. Research shows that CGM accuracy is greatly improved when a CGM device is calibrated from laboratory venous plasma glucose levels rather than glucose meter readings. Bolus calculators that correct for insulin stacking are common in insulin pumps.

They are also becoming more widely available in meters and phone applets for those who use insulin pens and injections. This increases the need for meter accuracy for more and more people using insulin. One review of 27 meters that had previously been approved with the ISO standard, only 16 of them actually met this standard in post-approval testing.

Someone with type 2 diabetes who uses diet only or medications with little risk of hypoglycemia would not require a meter that is as accurate as someone who is pregnant, someone who users insulin to maintain tight glycemic goals, or a critically ill patient in a hospital who is being treated with tight glycemic control protocols.

These include intensive glucose control with a bolus calculator, pregnancy, use in a child who is unable to communicate hypoglycemia symptoms, those with hypoglycemia unawareness, calibration of a CGM device, those with type 2 diabetes treated with diet or oral agents, and for hospital use.

Currently, the FDA gives a yes or no approval for meters that are submitted. Ideally, a panel of diabetes inpatient and outpatient clinicians would be formed to recommend the accuracy requirements for different groups. Yearly or biyearly retesting of the meter with at least 3 lots of test strips purchased from pharmacies or distributors will also be needed to ensure accuracy is maintained over time in the manufacturing process.

These and many other suggestions to improve meter accuracy and reduce clinical error are reviewed in recent publications. Standardized evaluation of nine instruments for self-monitoring of blood glucose. Assuring the accuracy of home glucose monitoring. J Am Board Fam Pract.

March 16 and 17,Gaithersburg, MD. AACE patient safety — editorials: Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use. Diabetes Res Clin Pract. Guidelines for optimal bolus calculator settings in adults.

J Diabetes Sci Technol. Journal of Diabetes Science and Technology ; 6 2 Accuracy in Blood Glucose Measurement:This article reviews devices for home monitoring of glucose and blood pres- accuracy of glucose meters, several groups have home glucose monitoring has been associated with improved.

Before approval, the FDA required a clinical study of diabetics, comparing the device’s accuracy to lab-conducted glucose readings while evaluating the potential risks, which are listed as allergic reactions, bleeding, bruising, infection, pain and discomfort, scarring, sensor .

What is glucose?

Accuracy of home glucose monitoring devices

Glucose is a sugar that your body uses as a source of energy. Unless you have diabetes, your body regulates the amount of glucose in your blood. Evaluation of a new blood glucose monitoring system with auto-calibration for home and hospital bedside use.

Diabetes Res Clin Pract. ;74(1)– Walsh J, Roberts R, Bailey T.

Accuracy of home glucose monitoring devices

Guidelines for optimal bolus calculator settings in adults. Modern blood glucose meters are smaller, faster, and more accurate than ever, and can help manage diabetes while maintaining an affordable annual strip cost.

The Accuracy of Home Glucose Monitoring Devices during Hypo and Hyperglycaemia. Self – monitoring of blood glucose at home is useful for the management of diabetes as it helps to monitor symptoms of hyper and hypoglycaemia (Diabetes UK).

Blood glucose monitors: What factors affect accuracy? - Mayo Clinic