Blood glucose monitoring

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Blood glucose monitoring
Blood Glucose Testing.JPG
Blood glucose testing, showing the size of blood drop required by most modern meters.
MeSH D015190

Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood (glycemia). Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin (typically, via fingerstick) to draw blood, then applying the blood to a chemically active disposable 'test-strip'. The other main option is continuous glucose monitoring (CGM). Different manufacturers use different technology, but most systems measure an electrical characteristic and use this to determine the glucose level in the blood. Skin-prick methods measure capillary blood glucose (i.e., the level found in capillary blood), whereas CGM correlates interstitial fluid glucose level to blood glucose level. Measurements may occur after fasting or at random nonfasting intervals (random glucose tests), each of which informs diagnosis or monitoring in different ways.

Contents

Healthcare professionals advise patients with diabetes mellitus on the appropriate monitoring regimen for their condition. Most people with type 2 diabetes test at least once per day. The Mayo Clinic generally recommends that diabetics who use insulin (all type 1 diabetics and many type 2 diabetics) test their blood sugar more often (4–8 times per day for type 1 diabetics, 2 or more times per day for type 2 diabetics), [1] both to assess the effectiveness of their prior insulin dose and to help determine their next insulin dose.

Purpose

Blood glucose monitoring reveals individual patterns of blood glucose changes, and helps in the planning of meals, activities, and at what time of day to take medications. [2]

Also, testing allows for a quick response to high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia). This might include diet adjustments, exercise, and insulin (as instructed by the health care provider). [2]

Blood glucose meters

Four generations of blood glucose meter, c. 1991-2005. Sample sizes vary from 30 to 0.3 ml. Test times vary from 5 seconds to 2 minutes (modern meters typically require less than 15 seconds). Glucose meters.jpg
Four generations of blood glucose meter, c. 1991–2005. Sample sizes vary from 30 to 0.3 μl. Test times vary from 5 seconds to 2 minutes (modern meters typically require less than 15 seconds).

A blood glucose meter is an electronic device for measuring the blood glucose level. A relatively small drop of blood is placed on a disposable test strip which interfaces with a digital meter. Within several seconds, the level of blood glucose will be shown on the digital display. Needing only a small drop of blood for the meter means that the time and effort required for testing are reduced and the compliance of diabetic people to their testing regimens is improved significantly. The cost of using blood glucose meters is believed to be a cost-benefit relative to the avoided medical costs of the complications of diabetes. [3]

Recent advances include:[ citation needed ]

Continuous glucose monitoring

A continuous glucose monitor determines glucose levels on a continuous basis (every few minutes). [4] A typical system consists of:

Continuous glucose monitors measure the concentration of glucose in a sample of interstitial fluid. Shortcomings of CGM systems due to this fact are:

Patients, therefore, require traditional fingerstick measurements for calibration (typically twice per day) and are often advised to use fingerstick measurements to confirm hypo- or hyperglycemia before taking corrective action.

The lag time discussed above has been reported to be about 5 minutes. [6] [7] [8] Anecdotally, some users of the various systems report lag times of up to 10–15 minutes. This lag time is insignificant when blood sugar levels are relatively consistent. However, blood sugar levels, when changing rapidly, may read in the normal range on a CGM system while in reality the patient is already experiencing symptoms of an out-of-range blood glucose value and may require treatment. Patients using CGM are therefore advised to consider both the absolute value of the blood glucose level given by the system as well as any trend in the blood glucose levels. For example, a patient using CGM with a blood glucose of 100 mg/dl on their CGM system might take no action if their blood glucose has been consistent for several readings, while a patient with the same blood glucose level but whose blood glucose has been dropping steeply in a short period of time might be advised to perform a fingerstick test to check for hypoglycemia.[ citation needed ]

Continuous monitoring allows examination of how the blood glucose level reacts to insulin, exercise, food, and other factors. The additional data can be useful for setting correct insulin dosing ratios for food intake and correction of hyperglycemia. Monitoring during periods when blood glucose levels are not typically checked (e.g. overnight) can help to identify problems in insulin dosing (such as basal levels for insulin pump users or long-acting insulin levels for patients taking injections). Monitors may also be equipped with alarms to alert patients of hyperglycemia or hypoglycemia so that a patient can take corrective action(s) (after fingerstick testing, if necessary) even in cases where they do not feel symptoms of either condition. While the technology has its limitations, studies have demonstrated that patients with continuous sensors experience a smaller number of hyperglycemic and hypoglycemic events, a reduction in their glycated hemoglobin levels and a decrease in glycemic variability. [9] [10] [11] [12] [13] Compared to intermittent testing, it is likely to help reduce hypertensive complications during pregnancy. [14]

Continuous blood glucose monitoring is not automatically covered by health insurance in the United States in the same way that most other diabetic supplies are covered (e.g. standard glucose testing supplies, insulin, and insulin pumps). However, an increasing number of insurance companies do cover continuous glucose monitoring supplies (both the receiver and disposable sensors) on a case-by-case basis if the patient and doctor show a specific need. The lack of insurance coverage is exacerbated by the fact that disposable sensors must be frequently replaced. Some sensors have been U.S. Food and Drug Administration (FDA) approved for 7- and 3-day use, (although some patients wear sensors for longer than the recommended period) and the receiving meters likewise have finite lifetimes (less than 2 years and as little as 6 months). This is one factor in the slow uptake in the use of sensors that have been marketed in the United States.[ citation needed ]

The principles, history and recent developments of operation of electrochemical glucose biosensors are discussed in a chemical review by Joseph Wang. [15]

Glucose sensing bio-implants

Investigations on the use of test strips have shown that the required self-injury acts as a psychological barrier restraining the patients from sufficient glucose control. [16] As a result, secondary diseases are caused by excessive glucose levels. A significant improvement of diabetes therapy might be achieved with an implantable sensor that would continuously monitor blood sugar levels within the body and transmit the measured data outside. The burden of regular blood testing would be taken from the patient, who would instead follow the course of their glucose levels on an intelligent device like a laptop or a smartphone.[ citation needed ]

Glucose concentrations do not necessarily have to be measured in blood vessels, but may also be determined in the interstitial fluid, where the same levels prevail – with a time lag of a few minutes – due to its connection with the capillary system. However, the enzymatic glucose detection scheme used in single-use test strips is not directly suitable for implants. One main problem is caused by the varying supply of oxygen, by which glucose is converted to glucono lactone and H2O2 by glucose oxidase. Since the implantation of a sensor into the body is accompanied by growth of encapsulation tissue, [17] the diffusion of oxygen to the reaction zone is continuously diminished. This decreasing oxygen availability causes the sensor reading to drift, requiring frequent re-calibration using finger-sticks and test strips.

One approach to achieving long-term glucose sensing is to measure and compensate for the changing local oxygen concentration. [18] Other approaches replace the troublesome glucose oxidase reaction with a reversible sensing reaction, known as an affinity assay. This scheme was originally put forward by Schultz & Sims in 1978. [19] [20] A number of different affinity assays have been investigated, [21] [22] [23] with fluorescent assays proving most common. [24] [25] [26] MEMS technology has recently allowed for smaller and more convenient alternatives to fluorescent detection, via measurement of viscosity. [27] Investigation of affinity-based sensors has shown that encapsulation by body tissue does not cause a drift of the sensor signal, but only a time lag of the signal compared to the direct measurement in blood. [28] A new implantable continuous glucose monitor based on affinity principles and fluorescence detection is the Eversense device manufactured by Senseonics Inc. This device has been approved by the FDA for 90 day implantation. [29] [30]

Non-invasive technologies

Some new technologies to monitor blood glucose levels will not require access to blood to read the glucose level. Non-invasive technologies include microwave/RF sensing, [31] [32] near IR detection, [33] ultrasound [34] and dielectric spectroscopy. [35] These may free the person with diabetes from finger sticks to supply the drop of blood for blood glucose analysis.[ citation needed ]

Most[ citation needed ] of the non-invasive methods under development are continuous glucose monitoring methods and offer the advantage of providing additional information to the subject between the conventional finger stick, blood glucose measurements, and overtime periods where no finger stick measurements are available (i.e. while the subject is sleeping).

Effectiveness

For patients with diabetes mellitus type 2, the importance of monitoring and the optimal frequency of monitoring are not clear. A 2011 study found no evidence that blood glucose monitoring leads to better patient outcomes in actual practice. [36] Randomized controlled trials found that self-monitoring of blood glucose did not improve glycated hemoglobin (HbA1c) among "reasonably well controlled non-insulin treated patients with type 2 diabetes" [37] or lead to significant changes in quality of life. [38] However a recent meta-analysis of 47 randomized controlled trials encompassing 7677 patients showed that self-care management intervention improves glycemic control in diabetics, with an estimated 0.36% (95% CI, 0.21–0.51) reduction in their glycated hemoglobin values. [39] Furthermore, a recent study showed that patients described as being "Uncontrolled Diabetics" (defined in this study by HbA1C levels >8%) showed a statistically significant decrease in the HbA1C levels after a 90-day period of seven-point self-monitoring of blood glucose (SMBG) with a relative risk reduction (RRR) of 0.18% (95% CI, 0.86–2.64%, p<.001). [40] Regardless of lab values or other numerical parameters, the purpose of the clinician is to improve quality of life and patient outcomes in diabetic patients. A recent study included 12 randomized controlled trials and evaluated outcomes in 3259 patients. The authors concluded through a qualitative analysis that SMBG on quality of life showed no effect on patient satisfaction or the patients' health-related quality of life. Furthermore, the same study identified that patients with type 2 diabetes mellitus diagnosed greater than one year prior to initiation of SMBG, who were not on insulin, experienced a statistically significant reduction in their HbA1C of 0.3% (95% CI, -0.4 – -0.1) at six months follow up, but a statistically insignificant reduction of 0.1% (95% CI, -0.3 – 0.04) at twelve months follow up. Conversely, newly diagnosed patients experienced a statistically significant reduction of 0.5% (95% CI, -0.9 – -0.1) at 12 months follow up. [41] A recent study found that a treatment strategy of intensively lowering blood sugar levels (below 6%) in patients with additional cardiovascular disease risk factors poses more harm than benefit. [42] For type 2 diabetics who are not on insulin, exercise and diet are the best tools.[ citation needed ] Blood glucose monitoring is, in that case, simply a tool to evaluate the success of diet and exercise. Insulin-dependent type 2 diabetics do not need to monitor their blood sugar as frequently as type 1 diabetics. [43]

Recommendations

The National Institute for Health and Clinical Excellence (NICE), UK released updated diabetes recommendations on 30 May 2008, which recommend that self-monitoring of plasma glucose levels for people with newly diagnosed type 2 diabetes must be integrated into a structured self-management education process. [44] The recommendations have been updated in August 2015 for children and young adults with type 1 diabetes. [45]

The American Diabetes Association (ADA), which produces guidelines for diabetes care and clinical practice recommendations, recently updated its "Standards of Medical Care" in January 2019 to acknowledge that routine self-monitoring of blood glucose in people who are not using insulin is of limited additional clinical benefit. [46] A randomized controlled trial evaluated once-daily self-monitoring that included tailored patient messaging and did not show that this strategy led to significant changes in A1C after a year. [38]

Related Research Articles

<span class="mw-page-title-main">Insulin pump</span> Medical device to administer insulin

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin therapy. The device configuration may vary depending on design. A traditional pump includes:

Intensive insulin therapy or flexible insulin therapy is a therapeutic regimen for diabetes mellitus treatment. This newer approach contrasts with conventional insulin therapy. Rather than minimize the number of insulin injections per day, the intensive approach favors flexible meal times with variable carbohydrate as well as flexible physical activities. The trade-off is the increase from 2 or 3 injections per day to 4 or more injections per day, which was considered "intensive" relative to the older approach. In North America in 2004, many endocrinologists prefer the term "flexible insulin therapy" (FIT) to "intensive therapy" and use it to refer to any method of replacing insulin that attempts to mimic the pattern of small continuous basal insulin secretion of a working pancreas combined with larger insulin secretions at mealtimes. The semantic distinction reflects changing treatment.

<span class="mw-page-title-main">Hyperglycemia</span> Too much blood sugar, usually because of diabetes

Hyperglycemia is a condition in which an excessive amount of glucose circulates in the blood plasma. This is generally a blood sugar level higher than 11.1 mmol/L (200 mg/dL), but symptoms may not start to become noticeable until even higher values such as 13.9–16.7 mmol/L (~250–300 mg/dL). A subject with a consistent fasting blood glucose range between ~5.6 and ~7 mmol/L is considered slightly hyperglycemic, and above 7 mmol/L is generally held to have diabetes. For diabetics, glucose levels that are considered to be too hyperglycemic can vary from person to person, mainly due to the person's renal threshold of glucose and overall glucose tolerance. On average, however, chronic levels above 10–12 mmol/L (180–216 mg/dL) can produce noticeable organ damage over time.

<span class="mw-page-title-main">Type 2 diabetes</span> Type of diabetes mellitus with high blood sugar and insulin resistance

Type 2 diabetes (T2D), formerly known as adult-onset diabetes, is a form of diabetes mellitus that is characterized by high blood sugar, insulin resistance, and relative lack of insulin. Common symptoms include increased thirst, frequent urination, fatigue and unexplained weight loss. Symptoms may also include increased hunger, having a sensation of pins and needles, and sores (wounds) that do not heal. Often symptoms come on slowly. Long-term complications from high blood sugar include heart disease, strokes, diabetic retinopathy which can result in blindness, kidney failure, and poor blood flow in the limbs which may lead to amputations. The sudden onset of hyperosmolar hyperglycemic state may occur; however, ketoacidosis is uncommon.

Glycated hemoglobin is a form of hemoglobin (Hb) that is chemically linked to a sugar. Most monosaccharides, including glucose, galactose and fructose, spontaneously bond with hemoglobin when present in the bloodstream. However, glucose is only 21% as likely to do so as galactose and 13% as likely to do so as fructose, which may explain why glucose is used as the primary metabolic fuel in humans.

<span class="mw-page-title-main">Glucose meter</span> Medical device for determining the concentration of glucose in the blood

A glucose meter, also referred to as a "glucometer", is a medical device for determining the approximate concentration of glucose in the blood. It can also be a strip of glucose paper dipped into a substance and measured to the glucose chart. It is a key element of glucose testing, including home blood glucose monitoring (HBGM) performed by people with diabetes mellitus or hypoglycemia. A small drop of blood, obtained from slightly piercing a fingertip with a lancet, is placed on a disposable test strip that the meter reads and uses to calculate the blood glucose level. The meter then displays the level in units of mg/dL or mmol/L.

<span class="mw-page-title-main">Type 1 diabetes</span> Form of diabetes mellitus

Type 1 diabetes (T1D), formerly known as juvenile diabetes, is an autoimmune disease that originates when cells that make insulin are destroyed by the immune system. Insulin is a hormone required for the cells to use blood sugar for energy and it helps regulate glucose levels in the bloodstream. Before treatment this results in high blood sugar levels in the body. The common symptoms of this elevated blood sugar are frequent urination, increased thirst, increased hunger, weight loss, and other serious complications. Additional symptoms may include blurry vision, tiredness, and slow wound healing. Symptoms typically develop over a short period of time, often a matter of weeks if not months.

The term diabetes includes several different metabolic disorders that all, if left untreated, result in abnormally high concentrations of a sugar called glucose in the blood. Diabetes mellitus type 1 results when the pancreas no longer produces significant amounts of the hormone insulin, usually owing to the autoimmune destruction of the insulin-producing beta cells of the pancreas. Diabetes mellitus type 2, in contrast, is now thought to result from autoimmune attacks on the pancreas and/or insulin resistance. The pancreas of a person with type 2 diabetes may be producing normal or even abnormally large amounts of insulin. Other forms of diabetes mellitus, such as the various forms of maturity-onset diabetes of the young, may represent some combination of insufficient insulin production and insulin resistance. Some degree of insulin resistance may also be present in a person with type 1 diabetes.

Fructosamines are compounds that result from glycation reactions between a sugar and a primary amine, followed by isomerization via the Amadori rearrangement. Biologically, fructosamines are recognized by fructosamine-3-kinase, which may trigger the degradation of advanced glycation end-products. Fructosamine can also refer to the specific compound 1-amino-1-deoxy-D-fructose (isoglucosamine), first synthesized by Nobel laureate Hermann Emil Fischer in 1886.

Automated insulin delivery systems are automated systems designed to assist people with insulin-requiring diabetes, by automatically adjusting insulin delivery in response to blood glucose levels. Currently available systems can only deliver a single hormone—insulin. Other systems currently in development aim to improve on current systems by adding one or more additional hormones that can be delivered as needed, providing something closer to the endocrine functionality of the pancreas.

A diabetic diet is a diet that is used by people with diabetes mellitus or high blood sugar to minimize symptoms and dangerous complications of long-term elevations in blood sugar.

<span class="mw-page-title-main">Diabetes management software</span>

Diabetes Management Software refers to software tools that run on personal computers and personal digital assistants to help persons with Type 1 and Type 2 diabetes manage the data associated with:

Chronic Somogyi rebound is a contested explanation of phenomena of elevated blood sugars experienced by diabetics in the morning. Also called the Somogyi effect and posthypoglycemic hyperglycemia, it is a rebounding high blood sugar that is a response to low blood sugar. When managing the blood glucose level with insulin injections, this effect is counter-intuitive to people who experience high blood sugar in the morning as a result of an overabundance of insulin at night.

<span class="mw-page-title-main">Prediabetes</span> Predisease state of hyperglycemia with high risk for diabetes

Prediabetes is a component of metabolic syndrome and is characterized by elevated blood sugar levels that fall below the threshold to diagnose diabetes mellitus. It usually does not cause symptoms but people with prediabetes often have obesity, dyslipidemia with high triglycerides and/or low HDL cholesterol, and hypertension. It is also associated with increased risk for cardiovascular disease (CVD). Prediabetes is more accurately considered an early stage of diabetes as health complications associated with type 2 diabetes often occur before the diagnosis of diabetes.

The dawn phenomenon, sometimes called the dawn effect, is an observed increase in blood sugar (glucose) levels that takes place in the early-morning, often between 2 a.m. and 8 a.m. First described by Schmidt in 1981 as an increase of blood glucose or insulin demand occurring at dawn, this naturally occurring phenomenon is frequently seen among the general population and is clinically relevant for patients with diabetes as it can affect their medical management. In contrast to Chronic Somogyi rebound, the dawn phenomenon is not associated with nocturnal hypoglycemia.

<span class="mw-page-title-main">Postprandial glucose test</span>

A postprandial glucose (PPG) test is a blood glucose test that determines the amount of glucose, in the plasma after a meal. The diagnosis is typically restricted to postprandial hyperglycemia due to lack of strong evidence of co-relation with a diagnosis of diabetes.

<span class="mw-page-title-main">Minimed Paradigm</span> Insulin pumps

MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention.

<span class="mw-page-title-main">1,5-Anhydroglucitol</span> Chemical compound

1,5-Anhydroglucitol, also known as 1,5-AG, is a naturally occurring monosaccharide found in nearly all foods. Blood concentrations of 1,5-anhydroglucitol decrease during times of hyperglycemia above 180 mg/dL, and return to normal levels after approximately 2 weeks in the absence of hyperglycemia. As a result, it can be used for people with either type-1 or type-2 diabetes mellitus to identify glycemic variability or a history of high blood glucose even if current glycemic measurements such as hemoglobin A1c (HbA1c) and blood glucose monitoring have near normal values. Despite this possible use and its approval by the FDA, 1,5-AG tests are rarely ordered. There is some data suggesting that 1,5-AG values are useful to fill the gap and offer complementary information to HbA1c and fructosamine tests.

Ambulatory glucose profile (AGP) is a single-page, standardized report for interpreting a patient's daily glucose and insulin patterns. AGP provides both graphic and quantitative characterizations of daily glucose patterns. First developed by Drs. Roger Mazze and David Rodbard, with colleagues at the Albert Einstein College of Medicine in 1987, AGP was initially used for the representation of episodic self-monitored blood glucose (SMBG). The first version included a glucose median and inter-quartile ranges graphed as a 24-hour day. Dr. Mazze brought the original AGP to the International Diabetes Center (IDC) in the late 1980s. Since then, IDC has built the AGP into the internationally recognized standard for glucose pattern reporting.

<span class="mw-page-title-main">Continuous glucose monitor</span> Blood glucose monitoring device

A continuous glucose monitor (CGM) is a device used for monitoring blood glucose on a continual basis instead of monitoring glucose levels periodically by drawing a drop of blood from a finger. This is known as continuous glucose monitoring. CGMs are used by people who treat their diabetes with insulin, for example people with type 1 diabetes, type 2 diabetes, or other types of diabetes, such as gestational diabetes.

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