What is HbA1c, and why does it matter?

Unlike other blood sugar tests, HbA1c reflects your average glucose levels over time. Here’s why it’s a useful marker for minding blood sugar.

The HbA1c test measures your average blood sugar over the past three months. It is a simple blood test frequently used to screen for and diagnose diabetes and monitor treatment.

HbA1c (also known as A1c) was first discovered in the late 1960s by researchers studying human hemoglobin A (HbA)—an iron-containing oxygen-carrying protein found in red blood cells. They noticed that HbA sometimes appeared in alternate forms, which the researchers designated HbA1a, HbA1b, HbA1c, and so on. These hemoglobin variants had different physical and chemical properties from normal hemoglobin, raising questions about their biological purpose.

By the late 1970s, researchers focused on HbA1c determined that it was formed by glycation—the chemical bonding of a glucose molecule to HbA. People with higher blood glucose levels (such as people with diabetes) were found to have higher levels of HbA1c. Excitement began to build around HbA1c as a marker of high blood sugar because people with higher HbA1c levels developed earlier and more severe diabetic complications. This suggested that doctors could use HbA1c to track how effectively people with diabetes control their blood glucose.

But it wasn’t until the landmark Diabetes Control and Complications Trial (DCCT) that HbA1c was firmly established as an important primary biomarker for diabetes management. The study, which ran from 1983 to 1993, followed 1,441 people with Type 1 diabetes. Participants were given either conventional therapy (one daily blood glucose measurement and 1-2 daily insulin injections) or intensive therapy (4+ daily blood glucose measurements and 3+ daily insulin injections or the use of an insulin pump). People in the intensive therapy group ultimately had lower HbA1c levels (indicating better blood glucose control) and lower rates of microvascular (small blood vessel) complications, such as retinopathy (eye damage that can cause vision loss), nephropathy (kidney damage that can lead to dialysis), and neuropathy (peripheral nerve damage that can lead to amputation).

After affirming the clinical importance of HbA1c testing, researchers faced a new challenge: standardization. By the early 1990s, it had become clear that test results varied significantly between different laboratories and countries. This inconsistency was due to the wide range of chemical techniques used to measure HbA1c—each of which defined the chemical target differently and suffered from unique error types. Laboratories and manufacturers also lacked a primary reference material (i.e., a pure sample of HbA1c to calibrate tests and machinery).

To solve this problem, two groups—the newly-formed National Glycohemoglobin Standardization Program and a working group at the International Federation of Clinical Chemistry and Laboratory Medicine—spearheaded a collaborative, multinational effort. These efforts (which unfolded over the next two decades) were successful, leading to the worldwide harmonization and standardization of HbA1c tests.

Today, clinicians use HbA1c (in combination with other tests) to diagnose diabetes and prediabetes and to monitor blood glucose management in people with diabetes.

What does HbA1c Measure?

The HbA1c test measures glycated hemoglobin in your bloodstream. In the US, Canada, and Japan, you’ll see this number as a percentage. For instance, an HbA1c test result of 5% would mean that 5% of the HbA molecules in your body have a glucose molecule bonded (or glycated) at Amino Acid #1.

Glycation, also known as the Maillard or the caramelization or “browning” reaction, occurs normally. It serves no biological purpose otherwise; it is simply a chance reaction between glucose and proteins in your body. It occurs in every organ, every day. It doesn’t need an enzyme or energy to occur. It’s also called the “aging” reaction—the reason you develop wrinkles and cataracts. Hemoglobin is made of four chains of amino acids folded together in a complex shape. When glucose encounters one of these chains ending with the amino acid valine, the two molecules form an irreversible covalent bond. Also, every time this Maillard reaction occurs, an oxygen radical (like hydrogen peroxide) is formed, which can cause cellular damage if not captured and detoxified by an anti-oxidant, such as Vitamin C or glutathione. Over time, these oxygen radicals (termed “oxidative stress”) can cause whole organs to fail.

The more glucose you have in your bloodstream, the more frequently these bonds occur and the higher your HbA1c level. But there is an upper limit on how high your HbA1c level can rise because your body constantly replaces red blood cells, which typically live for around 120 days. At that point, they are filtered by the spleen and broken down (along with any HbA1c they contain).

This 120-day lifespan (and the fact that glycation is a relatively slow chemical reaction) means that HbA1c levels act as a long-term biomarker for blood glucose levels. Unlike direct measurements of blood glucose (which can vary widely from minute to minute, hour to hour, and day to day), HbA1c levels reflect your average glucose levels over a three-month timeframe.

Why Would I Get HbA1c Tested?

Doctors generally test HbA1c for three reasons:

1. Diabetes screening.  The American Diabetes Association recommends that all people aged 45 and older get an HbA1c test, even if they have no symptoms or risk factors for diabetes.
2. Diabetes diagnosis. If you already have symptoms of diabetes or other risk factors (e.g., high blood pressure or first-degree relatives with diabetes), your doctor may use an HbA1c test to make an official diagnosis.
3. Diabetes management. If you have been diagnosed with diabetes, your healthcare provider may use periodic HbA1c tests to gauge how well you control your blood sugar.

In each case, the HbA1c level infers your average blood glucose over the prior three months. This result provides important information that alternative tests can’t. For instance, a fasting plasma glucose test (which requires patients to fast for 8-10 hours before the blood draw) only reflects your blood sugar at a single moment. Researchers have argued that these “snapshot” tests, even when performed twice, are less reliable than the HbA1c test in diagnosing chronically elevated blood glucose levels. This is partly due to “acute perturbations” — factors like stress, smoking, and diet that can influence a simple blood glucose reading on the day of your test.

The same is true of the oral glucose tolerance test (OGTT). In this test, you drink a large, sugary beverage. After a two-hour wait, doctors measure your blood glucose to see how effectively your body has cleared that glucose from the bloodstream. A healthy person’s blood glucose levels will spike at 30-60 minutes, followed by a fairly prompt decline by 120 minutes. In a person with insulin resistance or diabetes, however, blood glucose levels will remain high for an extended period. Like the fasting plasma glucose (FPG) test, this is a “snapshot” test that can be impacted by stress, sleep, and eating before the test, as well as the rate at which your stomach empties and your level of physical activity level in the preceding days.

The FPG and OGTT tests can also be swayed by laboratory errors that don’t affect HbA1c tests. Furthermore, they require 8-14 hours of fasting before the test (an instruction that some people may not successfully follow). For all these reasons, the HbA1c test is more reproducible than the FPG or the OGTT. If a person takes the HbA1c test twice, their results will likely be fairly close. If the same person takes an FPG or an OGTT, their results are less likely to match. For now, the OGTT is still considered the “gold standard” of diabetes diagnosis—but there is debate around this point.

Some authors argue that HbA1c is generally a more reliable indicator of chronic blood glucose elevation. Some recent research supports this view, such as a 2017 study of 3326 people in Singapore, which found that the HbA1c test outperformed the OGTT in classifying people with diabetes. Another study of 200 people in Hong Kong found that HbA1c was better for diagnosing diabetes and tracking its progression than the FPG test. And a 2012 study of 77 overweight or obese African American women and 5 African American men found that high HbA1c was superior to FPG testing in making a positive diabetes diagnosis (though a low HbA1c did not rule out diabetes).

Conversely, other research has reached the opposite conclusion. For instance, a 2012 study of 844 people in Italy at risk of Type 2 diabetes found that the OGTT was a better predictor of prediabetes and diabetes than HbA1c testing. Similarly, a 2019 study of 512 high-risk Thai patients found that HbA1c testing is “much inferior” to the OGTT as a diabetes screening tool. Finally, a 2015 study of 98 obese US youth found that the OGTT and HbA1c testing performed equally well. Again, this is an area of ongoing discussion and research, and the mainstream perspective may shift in the future.

It’s important to note that the HbA1c test has some limitations. For instance, medical conditions that shorten the lifespan of your red blood cells (such as the sickle cell trait) can produce a falsely low A1c reading. This is because your red blood cells quickly cycle out, giving hemoglobin glycation less time to occur. In this situation, an A1c test could incorrectly suggest that your glucose levels have been normal, even if they have been dangerously high. That’s why a diabetes diagnosis typically requires multiple types of glucose testing.

Not also that HbA1c only measures glucose fluctuations; it does not measure fructose variations in the blood, as fructose is more likely to bind to HbA at positions #66 and #110 rather than at position #1. This limits the use of HbA1c to diagnose or monitor sugar overconsumption.

A1c also captures only a long-term trend, not a picture of your daily glucose fluctuations (or glycemic variability), which can also impact your health.

How Do I Get HbA1c Tested?

The HbA1c test is not part of a standard blood chemistry panel. Your doctor is only likely to order it if they’re screening, diagnosing, or treating you for diabetes. But even if you don’t fit into one of those categories, you can still request an HbA1c test from your doctor. The HbA1c will start to rise at the onset of metabolic dysfunction, and many doctors use it as an early indicator. If your provider agrees that a test is appropriate, they will take a blood sample in their office or refer you to an outside laboratory. The test results typically come back in a day or two.

If your doctor doesn’t want to order an HbA1c test, you can order one directly from a retail laboratory. These tests usually cost $30-$50. Alternatively, you can order an at-home HbA1c test for the same price. To complete this test, you’ll submit a small blood sample by mail and get your results within a week. There are also at-home HbA1c electronic test devices. These are a little pricier (around $75) but give instant results and can be reused several times.

There is no way to infer your HbA1c level without testing it directly. However, every 30 mg/dL increase in average blood glucose correlates with an increase of HbA1c by approximately 1.0%.

What Are Optimal Ranges of HbA1c?

There is still some debate around ideal HbA1c levels. According to the American Diabetes Association, HbA1c results fall into three categories:

• Less than 5.7% signifies normal and healthy metabolism
• 5.7% to 6.4% signifies prediabetes
• 6. 5% or higher signifies full-blown diabetes

If you’ve recently taken an HbA1c test and are seeing higher results than you expected, don’t panic—there are several caveats to consider as you interpret your data. First, note that these tests have roughly a 0.4% margin of error. An HbA1c result of 6.0% may therefore signify prediabetes or be erroneously skewed upward from an HbA1c level of 5.6%.

Second, there may be racial, ethnic, age, and gender differences to account for when measuring HbA1c. Studies have shown that Black, Indigenous, Hispanic, and Asian people tend to have slightly higher HbA1c levels than white people. Research suggests that this is not due to higher underlying blood glucose levels but rather to racial/ethnic differences in red blood cell lifespan and other factors that affect hemoglobin glycation. In other words, the “safe” ceiling for HbA1c may be higher among people of color. The American Diabetes Association 2020 Standards of Care document states that “HbA1c levels may vary with race/ethnicity independently of glycemia. ” Some studies have also found that HbA1c levels tend to rise with age and run higher in men than women.

Finally, HbA1c results can be falsely raised or lowered by various factors. For instance, anemia, kidney dysfunction, and high triglycerides can all spike your HbA1c. Conversely, pregnancy, an enlarged spleen, and high vitamin E intake can all lower your HbA1c.

For these reasons, working closely with your healthcare provider when interpreting your HbA1c test results is essential. That said, elevated levels are associated with several severe health conditions. High blood glucose levels can damage your eyes, kidneys, heart, nerves, and blood vessels. Prediabetes puts you at risk for vascular disease, cancer, and dementia, whether or not it develops into full-blown diabetes. And even in people without diabetes, high HbA1c levels indicate metabolic dysfunction and are linked to heart disease and dementia.

It’s also important to note that some metabolic health experts, including many Levels advisors, are more conservative in their recommendations than the American Diabetes Association (ADA). While the ADA sets 5.7% as the safe ceiling for normal A1c levels, these specialists recommend 5.5% or even 5.0% as the optimal upper limit.

Based on their collective input, we suggest you aim for a level under 5.5%, noting that some experts say 5.0% is even better.

RACGP – HbA1c

The use of glycated haemoglobin, or HbA1c, has become the standard of assessing glycaemic control in patients with diabetes since the American Diabetes Association (ADA) recommended its use in 1988.¹ For decades, the diagnosis of diabetes relied on glucose criteria through using either fasting glucose, random glucose or the 75 g oral glucose tolerance test (OGTT). HbA1c was initially not endorsed for the diagnosis of diabetes; however, assay improvements led to the ADA validating its use in 2010 as a diagnostic criterion for diabetes at a cutoff of ≥6.5%, pre-diabetes between 5.7% and 6.4%, and normal <5.7%.² The HbA1c test is listed on the Medicare Benefits Schedule (MBS) for subsidy once every 12 months for the diagnosis of diabetes (HbA1c ≥48 mmol/mol [≥6. 5%]) in high-risk individuals, and up to four times per year for monitoring of established diabetes.³

What is HbA1c?

Haemoglobin is the iron-containing oxygen-transport protein present in erythrocytes. Normal adult haemoglobin (HbA) comprises a haem moiety and two globin chains, the α and β chains (α2β2), making up approximately 97% of adult haemoglobin.^4,5 Within HbA, approximately 6% is glycated, of which the main component is HbA1c (5%), with minor components of HbA1a and HbA1b (1%).⁴ HbA1c results from the covalent attachment of glucose to the N-terminal valine of the haemoglobin β-chain in a nonenzymatic process known as glycation.⁶

HbA1c is dependent on the interaction between the concentration of blood glucose and the lifespan of the erythrocyte.⁴ As the mean erythrocyte lifespan is approximately 120 days, HbA1c acts as a surrogate marker of glucose concentration during the preceding 8–12 weeks.⁶ As a result of the continuous turnover of erythrocytes, it is estimated that only 50% of an HbA1c value represents glucose exposure in the preceding 30 days, while 40% represents exposure in the previous 31–90 days and 10% in the previous 91–120 days. ⁴

HbA1c in the diagnosis of diabetes

HbA1c ≥48 mmol/mol (≥6.5%) in a laboratory using a validated method is diagnostic of diabetes. It should be measured in individuals at risk of diabetes. Advantages of measuring HbA1c for this purpose include its convenience without a need for pre-test preparation, sample stability when collected and less day-to-day variability. However, it is limited by various conditions affecting its accuracy (Table 1), greater cost and low sensitivity.² 

HbA1c targets

The Diabetes Chronic Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) were two landmark trials that unequivocally demonstrated the benefit of glycaemic control for delaying and reducing the rate of end-organ complications in type 1 and type 2 diabetes, respectively. ^7,8 The DCCT showed that intensive insulin therapy leading to HbA1c of 53 mmol/mol (7.0%, in comparison to 77 mmol/mol [9.2%] in the conventional arm) reduced the risk of retinopathy, nephropathy and neuropathy by 35–70%.⁸ However, the risk of severe hypoglycaemia increased with lower HbA1c values. The UKPDS demonstrated that achieving an HbA1c of 53 mmol/mol (7.0%) with intensive therapy using insulin or sulfonylurea (in comparison to 63 mmol/mol [7.9%] in the conventional arm) led to a 25% risk reduction in microvascular, but not macrovascular, outcomes.⁷

Tight glycaemic control appears to provide greater benefit if implemented early in the disease process when compared with implementation at a more advanced disease stage. Microvascular rather than macrovascular events are reduced with tight glycaemic control in more established disease.⁹ Higher rates of hypoglycaemia were evident in trial arms with intensive glycaemic control, and particular caution should be exercised in older patients, those with near-normal glycaemic control or those with a higher risk of cardiovascular disease. ⁹ Thus, while achieving HbA1c targets should form the focus of diabetes management, this needs to be weighed against the risks of intensive therapy. HbA1c targets should be individualised for each patient on the basis of their type of diabetes, life expectancy, risk of hypoglycaemia, duration of disease and other comorbidities. Guidance on HbA1c targets is detailed in the Australian Diabetes Society (ADS) recommendations (Table 2).

Table 2. Australian Diabetes Society position statement on recommended glycated haemoglobin (HbA1c) targets9
Condition	HbA1c target
General target	≤53 mmol/mol (7.0%)
Diabetes of short duration and no clinical cardiovascular disease
Lifestyle modifications ± metformin	≤42 mmol/mol (6. 0%)
Requiring any antidiabetic agent other than metformin or insulin	≤48 mmol/mol (6.5%)
Requiring insulin	≤53 mmol/mol (7.0%)
Pregnancy or preconception	≤42 mmol/mol (6.0%)
Diabetes of longer duration or clinical cardiovascular disease	≤53 mmol/mol (7.0%)
Severe hypoglycaemia or hypoglycaemia unawareness	≤64 mmol/mol (8.0%)
Major comorbidities likely to limit life expectancy	Symptomatic treatment of hyperglycaemia, aim for blood glucose level <15 mmol/L

Measurement of HbA1c

HbA1c assays work by separating glycated and non-glycated forms of haemoglobin, either on the basis of differences in the isoelectric point or by structure.^6,10 There are two main methods of reporting HbA1c. The National Glycohaemoglobin Standardisation Program (NGSP) method reports values in %, whereas the International Federation of Clinical Chemistry (IFCC) reports in mmol/mol.¹¹ The latter was developed to standardise international reporting of HbA1c. In Australia, both methods are reported concurrently. A conversion equation is as follows: NGSP (%) = 0.0915 × IFCC (mmol/mol) + 2.15.¹¹ There is a small margin of error in which the HbA1c measurement may vary for the same sample. Most methods report variations in HbA1c of 0.2–0.3%, but others may be higher.¹²

Additionally, there is increasing use of point-of-care testing devices that quantify HbA1c on the basis of structural differences and offer immediate turnaround of HbA1c results during a single visit. All approved devices must meet NSGP criteria for analytical performance, and studies have shown comparable accuracy with laboratory values.^13,14 Point-of-care HbA1c tests will be listed on MBS from 1 November 2021. ¹⁵

Causes of falsely low or high HbA1c

There are numerous causes of falsely low or high HbA1c measurements. These can be divided into factors that alter the lifespan or turnover of the erythrocyte, changes in glycation and haemoglobin, and assay-related artefacts (Table 1).

Conditions that reduce the erythrocyte lifespan, or increase its turnover so that there is shorter exposure to glucose, will lower HbA1c. Common causes include blood loss, haemolytic anaemia and hypersplenism.⁵ HbA1c may not be a reliable indicator of glycaemic control during pregnancy as there is reduced erythrocyte lifespan from 120 days to 90 days, and increased erythropoietin production.⁵ HbA1c values typically decline by 12–16 weeks of gestation, plateau by 20–24 weeks and rise again in the third trimester.⁵ End-stage renal failure is also associated with falsely low HbA1c levels due to chronic renal anaemia and reduced erythrocyte survival. Cystic fibrosis–related diabetes is associated with increased erythrocyte turnover and similarly causes low HbA1c. ¹⁶ Conversely, conditions that prolong the erythrocyte lifespan or reduce its turnover result in higher HbA1c. Common conditions include iron, vitamin B12 and folate deficiency anaemias and asplenia.⁵ Erythropoietin-stimulating agents and iron infusions in patients with renal failure can lead to falls in HbA1c, likely due to formation of new erythrocytes with reduced exposure to glucose and hence glycation.¹⁷

Haemoglobinopathies are genetic defects that result in abnormal structure of the globin chains, which in turn result in variable effects on HbA1c depending on the method of measurement and assay.⁵ This is similarly the case for haemoglobin variants. Vitamin E at doses of 600–1200 mg daily may reduce protein glycation, hence reducing HbA1c.⁵ Blood transfusions can increase the rate of glycation in red blood cells stored in high glucose concentrations for up to 42 days.¹⁸ However, when patients are transfused with red blood cells from a non-diabetic patient, increased erythrocyte turnover and a dilutional effect may falsely lower HbA1c. ⁵

Numerous assay-related artefacts can affect the HbA1c. Endogenous interference from hypertriglyceridaemia (>19.7 mmol/L) and hyperbilirubinaemia (>342 μmol/L), and detection of carbamyl-haemoglobin in patients with uraemia can all falsely elevate HbA1c.⁵

Finally, ethnic differences have been noted. Non-Caucasian populations have higher HbA1c values than Caucasian populations even after adjustment for confounders such as socioeconomic status, obesity and other diabetic factors.¹⁹ Non-glycaemic genetic determinants of glycation and differences in erythrocyte survival are potential causes.¹⁹

Is HbA1c the best method of assessing glycaemic control and are there alternatives?

Studies have indicated that progression of diabetic complications cannot be solely explained by HbA1c, as complications may occur despite lower-than-average HbA1c, and vice versa.²⁰ The most likely explanation is that HbA1c does not account for day-to-day glycaemic variabilities. Patients with widely differing glucose profiles may have the same HbA1c (Figure 1), and the use of HbA1c alone without any corroborative glucose measurements will not allow appreciation of intra-day glycaemic excursions. A reduction in glycaemic variability alone – for example, by hypoglycaemic avoidance – can lead to improved quality of life.²¹

Figure 1. An example of three glucose profiles exhibiting differing degrees of glucose variability with the same mean blood glucose and glycated haemoglobin.

There are alternative methods of assessing glycaemic control. Self-monitoring of blood glucose (SMBG) provides an indication of day-to-day variability. Average glucose levels may be extrapolated from the HbA1c using the formula: average blood glucose level (mmol/L) = 2 × HbA1c (%) – 6 mmol/L.¹⁰ However, infrequent SMBG will not provide glucose trends nor diagnose nocturnal or asymptomatic hypoglycaemia.²²

Continuous glucose monitoring (CGM) using either a flash or continuous system is a newer method of measuring interstitial glucose measurements at five-minute intervals. Whereas HbA1c can only provide information on long-term control, CGM offers comprehensive information on glucose variability and trends, thus providing clinicians with the ability to individualise diabetes management depending on the glycaemic pattern.²² The CGM report also includes the ‘glucose management indicator’, which is an estimated HbA1c measurement that is derived from mean glucose levels and thus not directly comparable to the laboratory-measured HbA1c.²² Other useful parameters obtained from CGM include the ‘time in range’ and the glucose ‘coefficient of variation’.²² As CGM becomes more widely accessible and used in outcome trials, it will likely become increasingly important as a tool for assessing glycaemic control.²³

Fructosamine is an alternative marker of glucose levels, as it is the product of glycation between glucose and protein, predominantly albumin.⁵ Glycated albumin is an example of a fructosamine. As the half-life of albumin (20 days) is much shorter than that of erythrocytes, it reflects glycaemic control over the past 2–3 weeks. ⁵ Nevertheless, fructosamine and glycated albumin are also subject to falsely low readings in states of hypoproteinaemia or hypoalbuminaemia.⁵ These tests may be considered when conditions affecting erythrocytes may affect HbA1c; however, their prognostic significance is unclear and thus not endorsed in official guidelines.^17,24

Glucose monitoring in specific populations

All populations

If the HbA1c measurement is deemed to be inaccurate (Table 1), assessment of glycaemic control should rely on SMBG (or CGM). To reduce glucose variability, normalisation of fasting and postprandial blood glucose levels should be strived for even if the target HbA1c is met, but this needs to be balanced against the burden of additional medications and their side-effect profile.

Type 1 diabetes

Apart from HbA1c and SMBG, CGM is particularly useful in patients with type 1 diabetes and may decrease time spent in hypoglycaemia.²⁵ Under the National Diabetes Services Scheme, CGM is currently subsidised for children and young adults aged under 21 years, adults aged 21 years and over with valid concessional status, and women who are actively planning pregnancy, pregnant or immediately postpartum.

Renal failure

Fructosamine and glycated albumin can be used as alternative glycaemic markers to HbA1c; however, low protein and albumin states limit their usage. Assessment of an SMBG diary over a period of time is likely to be more useful; CGM could also be considered.²⁶

Pregnancy

A 75 g OGTT rather than a HbA1c test should be used to diagnose diabetes.⁵ SMBG should be used for glucose monitoring and medication adjustment. CGM is another option, particularly for individuals with type 1 diabetes.

Patients with an unexplained discrepancy between HbA1c and glucose readings

It is important to first ensure appropriate SMBG technique and exclude hardware issues with the glucometer. Accuracy of glucometer measurements can be assessed using high and low control solutions from the manufacturer. Assessment of HbA1c using a different laboratory or assay may also be considered to confirm the accuracy of the initial measurement. If the discrepancy remains, frequent SMBG or CGM can be used to investigate this further.

Conclusion

HbA1c is a widely ordered and reviewed test in general practice. It is useful as an adjunct to other parameters such as SMBG or CGM to provide a holistic understanding of an individual’s recent glycaemic control. Care must be taken to consider various conditions and scenarios that may affect its measurement.

Key points

• HbA1c is the most widely accepted marker of glycaemic control in individuals with diabetes, and it correlates with risk of diabetic complications.
• HbA1c targets should be discussed and individualised according to type and duration of diabetes, life expectancy, risk of hypoglycaemia and other comorbidities.
• Numerous factors may falsely elevate or lower HbA1c, including anaemia, iron deficiency, renal failure and pregnancy.
• HbA1c does not take into account glucose variability, and two individuals with the same HbA1c may exhibit vastly different glucose profiles.
• Alternative methods of assessing glycaemic control, such as SMBG or CGM, can provide additional evidence about glycaemic excursions and should be used in conjunction with HbA1c if the data are available for review.

Hemoglobin (HbA1c) and other markers of diabetes

Hemoglobin (HbA1c) and other markers of diabetes – Product Information Hytest

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Diabetes is one of the most serious health problems of the 21st century and one of the leading causes of death in the world. Diabetes causes significant health costs due to the complications often associated with the disease. These complications include coronary and peripheral vascular disease, diabetic neuropathy, amputations, kidney failure, and blindness.

Diabetes is one of the most serious health problems in the 21st century.

Hytest offers antibodies and antigens for the development of immunoassays for the detection of various markers of diabetes such as hemoglobin (HbA1c), C-peptide and insulin.

Find the product of interest to your application by clicking the Products tab.

Glycated hemoglobin HbA1c

Several studies have shown that glycated hemoglobin (HbA1c) provides a better estimate of mean hyperglycemia than conventional blood glucose measurements. Measurement of HbA1c in the diagnosis of type 2 diabetes is recommended by the American Diabetes Association, the World Health Organization and the International Diabetes Federation.

Calibration curve for fluorinated HbA1c immunoassay. Capture antibody: anti-HbA10 (Cat. No. 4HH0). Detection antibodies: anti-HbA1c (cat. no. 4HA1). Calibrator: native HbA1c.

Proinsulin, insulin and C-peptide

Proinsulin, insulin and C-peptide assays are widely used to monitor hypoglycemia, pathogenesis and treatment of diabetes mellitus. Insulin is synthesized in the pancreas from its precursor proinsulin. During this process, proinsulin is proteolytically cleaved into three peptides: the A- and B-chain and the C-peptide. The A and B chains are covalently linked by disulfide bonds to form mature insulin.

Analysis of the synthesis and processing of proinsulin, as well as the release of insulin and C-peptide is very important for a better understanding of disorders of carbohydrate metabolism. Insulin, proinsulin, and C-peptide tests are widely used to monitor hypoglycemia, pathogenesis, and treatment of diabetes mellitus.

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Medical center “CONSULTANT” – Glycated hemoglobin

The measurement of glycated hemoglobin is carried out on the ADAMS Automatic Glycated Hemoglobin Analyzer, Arkray, Japan. Arkray equipment and reagents have been introduced into the world endocrinological practice and are successfully used in the leading clinical diagnostic laboratories of the Russian Federation. Analyzer Adams HA-8180V, Arkray is the most accurate analyzer in the world, which is confirmed by international quality certificates IFCC and NGSP, which Arkray receives annually.

Urgency of the problem
Currently, there are only 366 million patients with DM on our planet (7% of the world’s population). Experts of the World Diabetes Federation predict that the number of patients with diabetes by 2030 will increase by 1.5 times and reach 552 million people, i.e. every 10th inhabitant of the planet will get sick.

In modern endocrinological practice, the measurement of glycated hemoglobin (HbA1c) is an integral part of diagnosis and treatment selection. The determination of glycated hemoglobin is recognized as necessary to control the course of diabetes mellitus by the World Health Organization, and should be carried out once every 3 months in order to determine the effectiveness of treatment and assess the risk of complications.

The American Diabetes Association recommends that A1c be stable < 7.0%, tested and treated:
– Every 3-6 months (if A1c is stable < 7.0%)
– Every 2-3 months (if A1c is 7.0% – 9.0%)
– Every month (A1c > 9.0% until control is reached)

Benefits of HbA1c as a marker of early carbohydrate metabolism disorders:

1. More reliable glycemic indicator
2. Allows you to effectively assess the risk of complications
3. Test standardized
4. HbA1c is more stable as an analyte
5. Low variability
6. No need for frequent measurements, fasting measurements
7. The impact of stress on the result is minimal
8. Recommended for use in choice of therapy

The HbA1c value reflects the average level of glucose concentration in the patient’s blood during the 2-3 months preceding the study. Measurement of HbA1c allows in most cases to do without a glucose load test, which is not always safe for the patient and cannot be performed if the fasting blood glucose level exceeds 7.0 mmol / l.

Strict glycemic control is essential to reduce the risk of diabetes complications. Strict glycemic control, initiated immediately after the diagnosis of diabetes, can delay the development of microvascular and macrovascular diseases.

Quantification based on high performance liquid chromatography (HPLC) is recommended for the determination of hemoglobin fractions.

Glycated hemoglobin measurement is performed on the ADAMS Automatic Glycated Hemoglobin Analyzer, Arkray, Japan. Arkray equipment and reagents have been introduced into the world endocrinological practice and are successfully used in the leading clinical diagnostic laboratories of the Russian Federation. Analyzer Adams HA-8180V, Arkray is the most accurate analyzer in the world, which is confirmed by international quality certificates IFCC and NGSP, which Arkray receives annually.

Who should be tested for Hb1c?

• Diabetes monitoring
• Screening: people over 40 every 3 years
• Population over 40 with 1 or more risk factors (obesity BMI ≥30 kg/m2; hypertension)
• People with cardiovascular disease (myocardial infarction, angina pectoris, stroke or peripheral vascular disease)
• Obese women with polycystic ovary syndrome
• People taking antipsychotics (some drugs, especially glucocorticoids and antipsychotics, can interfere with glucose metabolism and increase the risk of diabetes)
• Women planning a pregnancy and at 24-28 weeks of gestation and 30-32 weeks in case of polyhydramnios during pregnancy)
• Women who had gestational diabetes (GDM) during pregnancy (6-8 weeks postpartum and 1-2 years postpartum).

GDM is the most common metabolic disorder in pregnant women encountered by endocrinologists and obstetrician-gynecologists. Despite advances in obstetric diabetology, the overall incidence of pregnancy complications and neonatal morbidity in GDM does not fall below 80%. The course of pregnancy in this pathology is complicated by the development of gestosis in 25-65% of cases, and its severe forms are observed in 2.9-3.7% of cases ¹ .

Due to the fact that in most pregnant women the disease occurs without severe hyperglycemia and obvious clinical symptoms, one of the features of GDM is the difficulty of its diagnosis and late detection.

Incidence of neonatal GDM:

• Erb’s palsy – 7.8%
• Severe asphyxia – 5.3%
• Fetal shoulder dystocia ~ 6.3%
• Fracture of the clavicle of a newborn – 19%
• Violation of cerebral circulation of traumatic genesis – 20%
• There is a high probability of developing hyperinsulinism and postnatal hypoglycemia, polycythemia and hyperbilirubinemia, neurological disorders GDM is a serious medical and social problem, because. significantly increases the frequency of undesirable pregnancy outcomes for the mother and for the fetus (newborn), is a risk factor for the development of obesity, type 2 diabetes and cardiovascular diseases in the mother and offspring in the future.