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Glucose Meters (Glucose Readers or Glucometers)
A glucose meter (or glucometer) is a medical device for determining the approximate concentration of glucose in the blood. It is a key element of home blood glucose monitoring (HBGM) by people with diabetes mellitus or with proneness to hypoglycemia. A small drop of blood obtained by pricking the skin with a lancet is placed on a disposable test strip, which the meter reads and uses to calculate the blood glucose level. The meter then displays the level in mg/dl or mmol/l.
Since approximately 1980, a primary goal of the management of Type 1 diabetes has been the achievement of closer-to-normal levels of glucose in the blood for as much of the time as possible, guided by HBGM several times a day. The benefits include a reduction in the occurrence rate and severity of long-term complications from hyperglycemia as well as a reduction in the short-term, potentially life-threatening complications of hypoglycemia.
There are several key characteristics of glucose meters that may differ from model to model:
The cost of home blood glucose monitoring is substantial due to the cost of the test strips. In 2006, the consumer cost of each glucose strip ranged from about $0.35 to $1.00, so that testing four times a day costs about $1.40 to $4 a day. Manufacturers often provide meters at no cost to induce use of the profitable test strips. Type 1 diabetics test as often as 10 to 12 times a day due to the dynamics of insulin adjustment, whereas Type 2 test less frequently, especially when insulin is not part of treatment.
Some batches of counterfeit test strips for some meters have been identified, and these have been shown to produce inaccurate results. They should not be used} and should be reported to the supposed manufacturer.
Accuracy of glucose meters is a common topic of clinical concern. Nearly all of the meters have similar accuracy (±10-15%) when used optimally. However, a variety of factors can affect the accuracy of a test. Factors affecting accuracy of various meters have included calibration of meter, ambient temperature, pressure use to wipe off strip, size of blood sample, high levels of certain drugs in blood, hematocrit, dirt on meter, humidity, and aging of test strips. Models vary in their susceptibility to these factors, and in their ability to prevent or warn of inaccurate results with error messages. The Clarke error grid is a common way of analyzing and displaying accuracy of readings related to management consequences. More recently an improved version of the Clarke error grid has come into use - this is known as the Consensus Error Grid.
The earliest widely-used meter was the Ames Reflectance Meter, which was used in American hospitals in the 1970s. It was about 10 inches long and required connection to an electrical outlet for power. A moving needle indicated the blood glucose reading after 60 seconds.
Home glucose monitoring was demonstrated to improve glycemic control of Type 1 diabetes in the late 1970s, and the first meters were marketed for home use around 1980. The two models initially dominant in North America in the 1980s were the Glucometer whose trademark is owned by Bayer and the Accu-Chek meter (by Roche). Consequently, these brand names have become synonymous with the generic product to many health care professionals.
Test strips that changed color and could be read "visually", without a meter, were also widely used in the 1980s. They had the added advantage that they could be cut with scissors longitudinally to save money. As meter accuracy and insurance coverage improved, they lost popularity and are no longer marketed.
At least in North America, hospitals resisted adoption of meter glucose measurements for inpatient diabetes care for over a decade. Managers of laboratories argued that the superior accuracy of a laboratory glucose measurement outweighed the advantage of immediate availability and made meter glucose measurements unacceptable for inpatient diabetes management. Patients with diabetes and their endocrinologists eventually persuaded acceptance.
Development of noninvasive devices may enable continuous monitoring. Research is being done on noninvasive methods for measuring blood glucose, such as using electric currents and ultrasound.
There is one noninvasive glucose meter that has been approved by the FDA: The GlucoWatch G2 Biographer is designed to be worn on the wrist, and it uses electric fields to draw out body fluid for testing. The device does not replace conventional blood glucose monitoring. One limitation is that the GlucoWatch system is not able to cope with perspiration at the measurement site. The sweat must be allowed to dry before measurement can resume. Due to these limitations and others, the product is no longer on the market.
It is speculated that within the next decade, meters may be replaced with continuous glucose sensors for many people with diabetes. This will likely decrease complications found in people with diabetes by limiting problems associated with hyperglycemia and hypoglycemia.
There are currently 2 CGMS (continuous glucose monitoring system) available. The first is Medtronic's Minimed Paradigm RTS with a sub-cutaneous probe attached to a small transmitter (roughly the size of a quarter) that sends interstitial glucose levels to a small pager sized receiver every 5 minutes. As well, the DexCom™ STS® System is available (2Q 2006). It is a hypodermic probe with a small transmitter. The receiver is about the size of a cell phone and can operate up to five feet from the transmitter. Aside from a two hour calibration period, monitoring is logged at five-minute intervals for up to 72 hours. High and low glucose alarms are user-settable.
There is currently an effort to develop an integrated treatment system with a glucose meter, insulin pump and wristop controller, as well as an effort to integrate the glucose meter and a cell phone. These glucose meter/cellular phone combinations are under testing and currently cost $149.00 USD retail. Testing strips are proprietary and available only through the manufacturer (no insurance availability.) These "Glugophones" are currently offered in three forms: as a dongle for the iPhone, an addon pack for LG model UX5000, VX5200, and LX350 cell phones, as well as an addon pack for the Motorola Razor cell phone. This limits providers to AT&T for the iPhone and Verizon for the others.
Many glucose meters employ the oxidation of glucose to gluconolactone catalyzed by glucose oxidase. Others use a similar reaction catalysed instead by another enzyme, Glucose Dehydrogenase (GHD). This has the advantage of sensitivity over glucose oxidase, but is more susceptible to interfering reactions with other substances.
The first-generation devices relied on the same colorimetric reaction that is still used nowadays in glucose test strips for urine. Besides glucose oxidase, the test kit contains a benzidine derivative, which is oxidized to a blue polymer by the hydrogen peroxide formed in the oxidation reaction. The disadvantage of this method was that the test strip had to be developed after a precise interval (the blood had to be washed away), and the meter needed to be calibrated frequently.
Most glucometers today use an electrochemical method. Test strips contain a capillary that sucks up a reproducible amount of blood and an enzyme electrode containing glucose oxidase. The enzyme is reoxidized with an excess of ferrocyanide ion. The total charge passing through the electrode is measured and is proportional to the concentration of glucose in the blood. The coulometric method is a technique used to define a reaction where the amount of charge measured over a fixed time is measured. The amperometric method is used by some meters that allows the reaction to go to completion and where the total charge transfer is measured. The coulometric method allows for a fixed test time, whereas test times with a meter using the amperometric techique can vary.
Meter use for hypoglycemia
Although the apparent value of immediate measurement of blood glucose might seem to be higher for hypoglycemia than hyperglycemia, meters have been less useful. The primary problems are precision and ratio of false positive and negative results. An imprecision of ±15% is less of a problem for high glucose levels than low. There is little difference in the management of a glucose of 200 mg/dl compared with 260 (i.e., a "true" glucose of 230±15%), but the difference between 70 mg/dl and 55 (i.e., 67±15%) represents a more unsatisfactory uncertainty.
The imprecision is compounded by the relative likelihoods of false positives and negatives in populations with diabetes and those without. People with Type 1 diabetes usually have glucose levels above normal, often ranging from 40 to 500 mg/dl (2.2 to 28 mmol/l), and when a meter reading of 50 or 70 (2.8 or 3.9 mmol/l) is accompanied by their usual hypoglycemic symptoms, there is little uncertainty about the reading representing a "true positive" and little harm done if it is a "false positive."
In contrast, people who do not have diabetes but periodically have hypoglycemic symptoms will have a much higher rate of false positives to true, and a meter is not accurate enough to base a diagnosis of hypoglycemia upon. A meter can occasionally be useful in the monitoring of severe types of hypoglycemia (e.g., congenital hyperinsulinism), to ensure that the average glucoses when fasting remain above 70 mg/dl (3.9 mmol/l).
YouTube Videos of Blood Glucose MetersMyDiabetesCentral.com:
Johns Hopkins Health Alerts on Diabetes:
The Diabetes Portal:
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