Despite the rising incidence of diabetes in the U.S., we have never been in a better position to use the tools at our disposal to effectively screen the population for diabetes.
By Jim Poggi, Principal, Tested Insights
Did you ever wonder: if lab testing impacts about 70% of all medical decisions, and if diabetes has been a known disease entity for over 3,500 years, and glucose testing has been a key element of our diagnostic arsenal for over 50 years, then why is diabetes incidence continuing to increase in the U.S.?
At the same time, it is right to ask “Are recent advances in treatment for type 2 diabetes going to help? Is our battle with diabetes at a pivot point? Have we moved on from treatment programs that put responsibility for management of type 2 diabetes (reduce carbohydrate intake, get more exercise and measure their glucose level as frequently as directed by the physician) on the patient who is likely resistant to needed life changes? Are there newer diagnostic and therapeutic tools that will assure a higher level of success in diabetic management?”
In this column, I intend to explore some of the history of diabetes, how we got where we are today and some speculation regarding where diagnosis and treatment of diabetes may go over the next few years. Spoiler alert: I do believe we are approaching a pivot point where diagnostics, treatment and patient compliance are all heading in the direction we need to reduce the incidence, cost and complications of this difficult-to-treat disease.
Back in the day
Despite being first recognized as a disease by the Egyptians in about 1500 BCE, diabetes has had a confounding history in terms of both definitive diagnosis and treatment. Early medical writings from Egypt, the Middle East, China and Rome all identified diabetes in various ways, but typically by recognizing the sweet smell of the urine characteristic of diabetes. Excessive thirst, patients losing body mass and longer-term complications such as blindness and damage to extremities were known morbidities of diabetes, but there was no effective diagnosis to identify diabetics, much less any way to treat the disease.
Little more was known about treatment until foundational work was done to isolate insulin deficiency as a cause of diabetes about 100 years ago. The synthesis of insulin and its availability as a treatment made a difference for some but not all persons with diabetes. Not until the late 1930s was the difference between type 1 (insulin deficient) and type 2 (insulin resistant) diabetes known. Insulin injections have been the first line treatment of type 1 diabetics since then. Several oral antiglycemic medications were developed and have made a difference in the treatment of type 2 diabetes, but there has not been a real breakthrough in treatment of type 2 diabetes until recently.
It took centuries to go from noting the sweet smell of diabetic urine to even determining what the cause of the smell was, glucose in the urine. From a diagnostic perspective, developing fast, accurate and convenient glucose testing has also been a challenge. Beginning in the mid 19th century, the first crude glucose methods were developed, but they were neither reliable nor widely available. Before the American Diabetes Association was founded in 1940 and the first reasonably reliable urine glucose methods were brought to market, there was no real thought for screening and little advocacy for the diabetic patient. Improved urine glucose methods were developed in the late 1940s and 1950s. But even these early urine testing methods still lacked the specificity to be the high-quality screening tools expected for a disease with such a high incidence.
Until the 1970s, there was no highly accurate and precise method of glucose testing on blood or urine. Between the 1960s and 1970s, improved laboratory methods for blood glucose tests replaced older methods and eliminated issues with specificity. In parallel, glucose meters that came to market in the 1970s had improved speed, result quality and customer acceptance, making home glucose testing a practical reality.
By the 1990s, glucose testing by glucose meter methods and in the laboratory added further improvements that made confident measurement of glucose in laboratory and home settings a reality. At the same time, recognizing the need to understand the average glucose concentration over time, hemoglobin A1C methods were developed. Providing a way to measure glucose concentrations over a 60- to 90-day period (as a function of how much glucose was bound to red blood cells) enabled physicians to understand the extent to which diet and exercise treatment programs were adhered to and how much of a difference they made. Hemoglobin A1C testing represented the first tool available to clinicians to truly understand patient compliance with their treatment program. No longer could non-compliant patients adjust their eating habits for a few days and attain a reasonable glucose level, appearing to their physician to be complying with their treatment program while they were not. This level of noncompliance and avoidance behavior has led to severe long-term comorbidities for these patients, including blindness and amputation.
Incidence of diabetes in the U.S. today
What is the current incidence of diabetes in the U.S. now, and is the rate of incidence decreasing or increasing? Sadly, now, diabetes is winning. Data from the Centers for Disease Control and Prevention (CDC) shows that there are presently 30 million Americans diagnosed with diabetes and a staggering 98 million prediabetics. Diabetes affects nearly 50% of the U.S. adult population.
How about the trend in incidence? This is also not a good story. Despite heart disease, cancer and lower respiratory diseases all declining in incidence between 2019 and 2020, diabetes is pulling ahead. With an increase of 14.8% it remains the eighth leading cause of morbidity and mortality and is implicated in heart disease, stroke and kidney disease that are all represented in the top 10. Equally disappointing, its increase in incidence is second only to unintentional injuries.
What is blocking progress?
The advent of better diagnostic tests, and particularly hemoglobin A1C to help distinguish patients working hard to engage in healthy life habits from those “hoping no one will notice,” improves the physician’s ability to properly coach their patients. And, some patients have embraced healthy living habits willingly, eating better and exercising more frequently. But, unfortunately, the “unworried unwell” still prevail in the diabetic population, as evidenced by the data. The fact that diabetes is a tough disease to conquer, coupled with the “unworried unwell” either deciding that change in not worth their time or that they feel OK and do not need to make any adjustments in their life are, are probably the dominant reasons that diabetes is so stubborn in the U.S.
Can we screen the “unworried unwell”?
We have never been in a better position to use the tools at our disposal to effectively screen the U.S. population for diabetes and prediabetes. With the substantial number of undiagnosed prediabetics (who most likely are also asymptomatic and therefore unaware of the need to act) by implementing large scale diabetes screening we could dramatically reduce the future incidence of diabetes and re-shape the leading causes of morbidity and mortality.
In the year for which I have the most recent data (2017), over 20 million patients with diabetes visited a primary care practice. That’s less than 16% of the total U.S. diabetic population. Do we have the resources, funding and reach to diagnose a significant percentage of the 98 million undiagnosed diabetics in the U.S.? Unlikely. To do so would require a massive focus in time, personnel and budget to get to the enormous number of undiagnosed diabetics in the U.S. It is also unlikely that there are enough primary care physicians to screen and evaluate that large of a patient base. Communicating with such a large cohort of patients itself is a daunting task.
But what if the target goal was to reach 10% of the undiagnosed diabetic population, or just under 10 million patients? If there was a concerted effort to do so, I consider it within the realm of possibility. With the current primary care practitioner base, reaching this number of patients would increase the visit load per practitioner by 37 visits per year, just under one a week. And this assumes that every undiagnosed patient is a new patient, which is very unlikely. While a heavy lift, I do not consider it impossible if control of diabetes were to be prioritized in the current U.S. healthcare environment which seeks to manage chronic conditions.
Why am I proposing such a “blue sky” scenario? Because I believe both the diagnostic and treatment tools are at the point where early diagnosis and intervention can positively impact the lives of the U.S. prediabetic population and reduce the overall morbidity and mortality rate associated with diabetes and its comorbidities. Administrative action and prioritization from the Department of Health and Human Services is certainly the most direct way to create needed focus. The new administration is actively prioritizing chronic diseases, but it is not presently clear where diabetes fits in. But as trusted consultants to our customers, we have the communication channel and the diagnostic and treatment tools to discuss the possibilities with them and gauge their interest in acting. We can start dialogue and see where it takes us. Every distribution account manager needs to think about how this strategy would work for them and work with their management to decide how to proceed and to what extent. But you must admit it is an intriguing idea.
Your diagnostic and treatment tools
From a diagnostic viewpoint, we are in an excellent position. The greatest need is to get patients in front of the diagnostic tools. Hemoglobin A1C has proven its worth as an excellent way to diagnose prediabetics. There are several peer reviewed articles attesting to the success rates of this diagnostic tool. Ask your trusted lab product manufacturer to help you understand the information and provide you with the value proposition and qualifying questions to discuss this option with your key customers.
There is a range of CLIA waived and moderate complexity options to present to your customers. Be sure to confirm that the options you are proposing are cleared for diagnosis, as well as monitoring of hemoglobin A1C levels. In addition, there is renewed emphasis on “two-hour post prandial” glucose measurements. Granted, assuring the right time between the initial glucose meal, the start of fasting and measurement of glucose needs to be carefully controlled, but the difference in glucose levels at two hours is significant between normal patients and those with diabetes. The data I have seen shows about an 80-90 mg/dL difference between these two groups. It is significant enough to be easy to identify.
Consult with your trusted quantitative glucose manufacturer to get the facts and help you be able to offer this option. At the same time, changes in technology and availability of technology have made continuous glucose monitoring a reality for patients post diagnosis. There are multiple options available today and your lab category team, colleagues and manager can point you to the leading options. Why is this important? Because ready availability of this information can help patients manage compliance and make life changes needed to control their glucose levels. This is not an easy change, and this tool provides needed feedback showing progress.
Treatment options have also undergone significant changes in the past few years, taking away the clinician objection of “I can diagnose diabetes, but I may not be able to treat it effectively.” There is now a simple, fast and effective way to diagnose changes in retinal blood flow to help detect changes before diabetic retinopathy occurs, preserving eyesight for the diabetic patient.
Finally, who has not seen the television ads for new diabetic treatment choices from a new class of drugs called GLP-1 agonists? This new category of treatment involves giving the patient a drug that mimics what “glucagon like peptides” do in the normal patient: regulate insulin levels and carbohydrate metabolism. Their mechanism of action is broad based and while regulating insulin availability, they also regulate appetite and work to restore a more normal metabolic balance in patients with type 2 diabetes.
While understanding their mechanism of action is complicated, the results are impressive. There are multiple options on the market today and results in controlling type 2 diabetes and triggering weight loss have been well documented. While they do not restore the normal metabolic balance and must be administered on an ongoing basis, there is no doubt that they provide an effective, new means of controlling the metabolic factors involved in type 2 diabetes. Expect even more advanced therapeutic choices as pharmaceutical companies analyze the results of patient treatment and look for ways to create even more sophisticated and long-lasting treatment options.
Diabetes: Can we beat it?
Diabetes has been a long-term problem in the U.S. It has eluded diagnosis since it remains asymptomatic until it is often too late to effectively reverse. Patients have often been unmotivated since they feel well and see no real need to change life habits.
At the same time, while diagnostic tools have been available, the number of undiagnosed diabetics in the U.S. has risen to nearly 100 million showing diabetes has resisted our efforts to control it. And treatment options for type 2 diabetes have shown modest effectiveness unless coupled with patients willing to take charge of changing their eating and exercise habits.
Now with better-than-ever diagnostic tools and new-and-improved treatment choices, I believe we finally have a chance to take diabetes on with the prospect of reducing its incidence and impact on the health of Americans. The question remains: what will it take to do it? Can we exercise our skills and abilities as respected consultants to ask our key customers to put more focus on diagnosis of diabetes? Can public health clinics step and help work to improve reach in diagnosis? I believe we have the tools.
I do not expect a new U.S. healthcare focus on diabetes with the intent to radically drive down incidence. We likely could not effectively manage that scale of an initiative. But, what if, as trusted consultants, we led grass roots activities – community screening programs, health fair days, support for community healthcare clinics and messaging to our key customers on actively screening for diabetes. I believe that is where we can provide guidance, effective consultation and could make a difference.
What’s the old saying? “Think globally but act locally?” I believe that is where each of us can make a difference, and our combined efforts can make a substantial difference.