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A Single Blood Sample May Be Sufficient to Diagnose Diabetes
In a study, the test accurately predicted prediabetes and diabetes, and avoided false diabetes diagnoses as well.
By Shari Roan
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June 25, 2019
More than 7 million Americans with diabetes don’t know they have the disease, and in addition, many millions may unknowingly have prediabetes, a borderline condition that typically precedes diabetes. But a simplified testing regimen may lead to more people being diagnosed and treated for the disease.
Researchers at the Johns Hopkins Bloomberg School of Public Health have shown it’s possible to accurately diagnose type 2 diabetes by using a single blood sample. Current guidelines call for two separate blood tests to make a diagnosis. But some patients don’t follow up with the second test and remain undiagnosed and untreated, says Elizabeth Selvin, PhD, lead author of the study and a professor in the department of epidemiology at Johns Hopkins University in Baltimore.
“To confirm the diagnosis, the test must be repeated with a new blood sample at a second point in time,” she says. “The patient has to schedule another visit, which could be costly or burdensome. If the patient doesn’t return for that second visit, there could be a missed diagnosis.”
Not receiving a proper diagnosis and treatment advice may increase the risk of diabetes-related health complications. More than 30 million Americans have diabetes, with about 7.2 million of those people being undiagnosed, according to the American Diabetes Association (ADA). About 84 million American adults have prediabetes, the ADA notes.
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A One-Stop Shop for a Prediabetes or Diabetes Diagnosis?
The standard testing regimen to diagnose type 2 diabetes involves an initial blood test to gauge fasting levels of glucose or hemoglobin A1c (HbA1c or A1C), according to the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK). If that test is positive, meaning the level is higher than normal, a second test is ordered to confirm the finding. In this new study, published June 19, 2019, in the journal Annals of Internal Medicine, Dr. Selvin and her colleagues looked at the accuracy of using a single blood sample to measure both glucose and HbA1c.
They examined data from the Atherosclerosis Risk in Communities Study, which involved more than 13,000 people. The study was established to look at risk factors for heart disease, and data on blood glucose and HbA1c was gathered as part of the study. An analysis showed that 383 people who were not diagnosed with diabetes at the time had positive results on both blood glucose and HbA1c taken from a single blood sample. Almost all of these individuals eventually developed diabetes (99.6 percent by 15 years). The test was accurate at avoiding a false diagnosis of diabetes as well.
That finding suggested that positive results regarding glucose and HbA1c from one blood sample was accurate enough to diagnose diabetes. A positive fasting glucose test is considered 126 or above, while a positive HbA1c test is 6.5 percent or above, according to the NIDDK.
“We also looked at the development of cardiovascular disease and chronic kidney disease to understand whether people with both elevated glucose and HbA1c have a higher risk of complications, and they absolutely did,” she says. The one-sample regimen “is an important change in that it represents a streamlined approach to diagnosing that is strongly associated with clinical outcomes.”
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A Closer Look at How Doctors Currently Test for Prediabetes and Diabetes
But diagnosing diabetes has already changed dramatically over the past decade or two to become simpler, says Sethu Reddy, MD, a professor of medicine and chair of medicine at Central Michigan University College of Medicine in Mt. Pleasant. Even a decade ago, patients had to fast for 10 hours before a blood draw, or take a glucose tolerance test, which involved a fasting blood test followed by consuming a glucose drink and then another blood test, Dr. Reddy says.
Today, Reddy says, many endocrinologists use a blood test measuring A1C to check for diabetes or prediabetes and begin working with a patient on lifestyle changes, such as diet and medication adjustments, even on the basis of one positive test.
“Right now, most of us do fasting glucose, and if fasting is not possible, we just do an A1C test,” he says. “It’s important for doctors, when we do tests, to decide 'how does it affect our decisions?' Whether someone has prediabetes or diabetes, I would treat them the same way,” with possible adjustments to medication, lifestyle counseling, and regular A1C testing, Reddy adds.
The sooner an individual learns he or she has diabetes or prediabetes, the better, Selvin says. Left untreated, diabetes can lead to numerous health problems, including eye disease, kidney disease, and peripheral vascular disease, which can lead to numbness and sores on the feet. Diabetes also raises the risk for heart disease and stroke, according to the American Association of Clinical Endocrinologists.
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How the New Blood Test May Help Improve Diabetes Care
“I think we do a good job in this country with screening and diagnosis. But simplifying things and making it easy for the physician to diagnose this disease would help make sure we capture people early so we can prevent complications,” she says. “This approach can also help further our prevention efforts. If a person doesn’t meet criteria for diabetes, they may still have elevated levels. So that suggests it’s an efficient way to capture people with prediabetes. Those people should be monitored.”
For people who have just one positive result — either high glucose or high HbA1c — a second blood test should be recommended, Selvin says.
Diabetes experts are scheduled to review guidelines for diagnosing and treating the disease early next year.
“It’s very common for physicians to measure multiple things in one same at a single visit. But the guidelines are not clear that you cannot make a diagnosis on the basis of that single sample,” Selvin says.
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