When David G. Marrero, PhD, talks about diabetes, he is not shy about using strong language. “Diabetes may be the most serious public health crisis of our time,” said Marrero, director of the University of Arizona Health Sciences Center for Border Health Disparities in Tucson. “If you think our healthcare system is stressed now and that the costs are exacerbated, put another 40 to 50 million people with diabetes into the mix, and we’ll be in very deep trouble.”
According to the Centers for Disease Control and Prevention (CDC), 30.3 million people—or 9.4 % of the U.S. population—had diabetes in 2015, and in the same year, about 1.5 million new cases of diabetes were diagnosed among adults age 18 or older. The CDC also estimates that 33.9% of U.S. adults had prediabetes. The economic burden of diabetes is massive. The American Diabetes Association (ADA) estimates that the cost of diagnosed diabetes in the U.S. hit $327 billion in 2017, with reduced productivity costing another $90 billion (Diabetes Care 2018;41:917-928).
On average, a person with diabetes has 2.3 times higher medical costs than someone without diabetes. Individuals with diabetes incur average medical expenditures of about $16,750 a year, of which $9,600 is directly attributable to diabetes. And those numbers are rising. When adjusted for inflation, the economic costs of diabetes jumped 26% from 2012 to 2017, both from the growth in the number of people with diabetes and in increased medical costs, according to the ADA.
Aside from these costs, diabetes extracts a heavy toll in loss of quality of life—and human life itself. This disease can lead to heart attack, stroke, blindness, amputation, and kidney failure. It is the seventh leading cause of death in the U.S., and about 277,000 premature deaths were attributed to diabetes in 2015.
“Last year, more people died from diabetes-related issues than from breast cancer and AIDS combined,” Marrero noted. “People don’t always appreciate that because it’s often a non-visible disease and not acutely traumatic like many cancers. Many people have diabetes for years, and by the time they become clinically symptomatic, they’re in serious trouble.”
Laboratory testing is key to identifying who has diabetes so that the disease can be brought under control and monitored to reduce the chances of complications. Identifying who has prediabetes also helps clinicians put patients on a path to prevention. While the awareness of diabetes and the need for testing is better, it must be improved, Marrero said. “I would not say that screening is absolutely systematic, but it is much more common,” he said. “Because of diabetes prevention programs and the concept of prediabetes, and the Centers for Medicare and Medicaid Services covering the benefit for prediabetes prevention, people are starting to look for it a little more.”
Whom to Screen
The U.S. Preventive Services Task Force (USPSTF), an independent panel of experts in disease prevention and evidence-based medicine convened by the federal government, recommends screening patients age 40 to 70 years old who are overweight or obese.
Researchers at Northwestern Medicine in Chicago estimate that using just these two criteria would miss screening 53% of high-risk patients (J Gen Intern Med 2018;33:1100-8). This means that more than half of people with prediabetes or diabetes won’t be tested according to the USPSTF screening guideline.
“There is a role for making screening recommendations based on the most rigorous evidence, and USPSTF provides an important service in doing so. But I worry that this particular guideline is too restrictive because it misses a lot of vulnerable groups,” said the study’s lead author Matthew J. O’Brien, MD, an assistant professor of medicine at Northwestern University Feinberg School of Medicine.
Expanding screening criteria to include risks like a family history of diabetes, history of gestational diabetes and polycystic ovarian syndrome, or non-white race or heritage could cut the missed screening population down to 23% of high risk patients, O’Brien said.
O’Brien doesn’t see a downside of increasing the number of people who are screened. “If someone has diabetes that’s undiagnosed, they’re clogging their arteries in their hearts and brains and damaging their kidneys and their eyes and don’t know it,” he said. Living in this compromised state of health leads to more expensive healthcare costs down the line, and higher chances for morbidity.
Testing, combined with proven successful diabetes prevention programs for those with prediabetes, can reverse this dire circumstance for many individuals. Very inclusive screening criteria that “capture the most people who have the condition allows us to address it,” O’Brien emphasized. He compared testing for diabetes to two other widely implemented screening tests, colonoscopy and mammography. The former can cost thousands of dollars and risks tearing of the colon or rectum wall. Mammograms cost only a few hundred dollars, but more than 50% of women screened annually for 10 years will have a false positive test for breast cancer, which can lead to undue further testing and stress for these patients. In contrast, screening for diabetes is inexpensive and confers little risk.
The hemoglobin A1c (HbA1c) test gives a picture of an average blood sugar level over a 2- to 3-month period and is the gold standard in assessing glycemic control in patients with type 2 diabetes. It also has been gaining ground as a favored option for diabetes screening. Marrero said HbA1c results can be combined easily with an online seven-question ADA type 2 diabetes risk test. “If you put those things together, you have a pretty good idea of the possibility of having diabetes, which may then indicate a more aggressive follow up,” he said.
It also may only take one blood sample—from which a laboratory can perform both HbA1c and fasting glucose testing—to diagnose diabetes, according to a recent Johns Hopkins Bloomberg School of Public Health study (Ann Intern Med 2018;169:156-64). Clinical guidelines recommend that a second blood test at a second visit should confirm an initial elevated fasting glucose or HbA1c result. However, the study authors found that a single-sample protocol could make diabetes screening much more efficient compared to the current practice that may lead to missed diagnoses.
“Doctors are already doing these tests together—if a patient is obese, for example, and has other risk factors for diabetes, the physician is likely to order tests for both glucose and HbA1c from a single blood sample,” said the study’s lead author, Elizabeth Selvin, PhD, MPH, in a statement. Selvin is a professor of epidemiology at Johns Hopkins in Baltimore. “It’s just that the guidelines don’t clearly let you use the tests from that one blood sample to make the initial diabetes diagnosis.”
The accuracy of HbA1c tests continues to improve, too, according to David B. Sacks, MB ChB, FRCPath, chair of the National Glycohemoglobin Standardization Program and chief of the clinical chemistry service in the department of laboratory medicine at the National Institutes of Health Clinical Center in Bethesda, Maryland. In a 2011 paper published in Clinical Chemistry, he referred to the “chaos” of diabetes testing because, while HbA1c was discovered as a mark of diabetes in the 1960s, methods and analytical performances weren’t close to being uniform until this century (Clin Chem 2011;57:205-14).
By 2009, HbA1c had shown to be better than glucose in predicting the risk of microvascular complications of diabetes, and started to be recommended for diagnosis of diabetes in 2010 by the ADA and the following year by the European Association for the Study of Diabetes and the International Diabetes Federation. Now, he said, certification criteria for manufacturers of HbA1c methods are much tighter and more standard across the globe.
“There’s always room for improvement. The acceptance criteria for passing methods and for passing individual labs is planned to be tightened in 2019 and 2020,” Sacks said. “That’s because the manufacturers have improved the assays so much that this further tightening of criteria is feasible.”
The value of the HbA1c test is not just in identifying patients with diabetes and prediabetes, but in helping patients set goals for themselves. According to a recent University of Chicago study published in the Annals of Internal Medicine, the cost of diabetes care over a patient’s lifetime is on average $13,547 lower for patients who were given individualized goals for lowering their HbA1c level, which, when extrapolated over the lifetimes of all U.S. patients who currently have type 2 diabetes, could be about $234 billion (Ann Intern Med 2018;168:170-8).
Testing for Diabetes in the Real World
The Ochsner Health System in southeast Louisiana is a leader in innovative programs in population health, including a defined diabetes management program. Ochsner looks past the traditional fee-for-service model and takes a larger, overall look at patients’ health and healthcare costs, said Pavan Chava, DO, an endocrinologist and director of the diabetes management program. “We have the ability within our system to create registries…and capture all of our patients who have diabetes,” he said. “It gives us the ability to fine tune some of our messaging and make sure they’re getting the tests they need.”
That includes identifying which patients are not up to date on their HbA1c tests. Ochsner sends these patients messages through its patient portal system and then notifies its clinical laboratories. “It doesn’t require contacting their physician to put the order in or waiting for staff to schedule,” he said.
Patients are told they can get the test done at their convenience and without an appointment, which makes it easier for them to stay current on testing, Chava said—the ultimate goal. Changing from appointment-based testing to this new system required close coordination with clinical laboratory professionals. The concern was that Ochsner’s laboratories would be overwhelmed with patients coming in, without appointments, all at the same time. “We set up some protocols to keep track of when we put an order in and what percentage of people actually do go to a lab,” Chava said. “That gives us a better ability for lab staffing and also understanding the value of patients coming in.”
Chava said that the registry is only beneficial with accurate data. This required educating “all of our healthcare providers on using appropriate diagnoses. It’s not uncommon where a patient may be diagnosed with diabetes when they have prediabetes,” he said. “You don’t want to be sending a patient that message that they have diabetes when they actually don’t. Make sure you have good infrastructure to handle that.”
Routine and effective testing and monitoring that’s easy for patients is crucial for getting a better handle on diabetes and prediabetes. “We can’t rely on them coming in when they have symptoms,” Paven emphasized.
While reducing the financial impact and stress on the healthcare system from diabetes is important, clinical laboratorians and clinicians cannot lose sight of why proper diagnosis and monitoring of diabetes and prediabetes is so important: how patients’ lives can improve if they don’t develop diabetes or get their condition under control, Chava commented. “More importantly from the perspective of patients, we want to help them live their lives to the fullest where diabetes isn’t the predominant thing in their lives. It’s just managed.”
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. +EMAIL: jenmiller27[at]gmail.com
This special supplement is supported by Abbott.