• November 30, 2022

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The 2020s are off to a tumultuous start. Individuals have experienced extraordinary political and social upheaval, war on the European continent, the reemergence of infectious diseases, financial instability, scandals, and extreme …

This winter, the United States is facing the “Perfect Storm” of COVID, flu and Respiratory Syncytial Virus (RSV). While the White House, HHS, FDA, and a host of governmental agencies focus on this immediate threat, they also are preparing for the next pathogen attack.

The surges in flu and RSV tend to be seasonal with abatement coming in the spring while fighting Covid-19 will remain an ongoing battle. As great as all these threats may be, there looms an even greater challenge that demands equal, if not more, attention – Diabetes.

On October 31, the White House declared this to be National Diabetes Month. You can be forgiven if you did not know that such a designation exists, but be slow to put this in the category of National Barbecue Day (May 16) because it is a safe bet that you already know someone who has diabetes since over 11% of the US population is known to be diabetic; that translates into 37,300,000 people. Compounding the problem are the estimated 8,500,000 people who have diabetes but remain undiagnosed.

Next consider the costs diabetic patients bear. People with diagnosed diabetes incur average medical expenditures of $16,752 per year, of which about $9,601 is attributed to diabetes. On average, people with diagnosed diabetes have medical expenditures approximately 2.3 times higher than those without diabetes.

Pre-diabetes, as the name suggests, is the clinical condition characterized by slightly elevated blood glucose levels that, without lifestyle changes, puts a person at risk of progressing to Type 2 diabetes. The CDC estimates that 96,000,000 adults (38% of the population) in the United States are pre-diabetic and 80% of them do not know that they have it!

Imagine the social and economic consequences when one half of the adult US population develops diabetes. At the rate of 1.5 million new cases per year, it is not a question of if, it is simply a question of when. (I suspect there is a Hedge Fund modeling computer somewhere using an algorithm that has calculated when we will reach that milestone.)

If we hope to halt, or at least slow, the insidious progression of diabetes, we need a simple tool – Information. Counterintuitively, this may require disassociation from the FDA and the health care reimbursement system in favor of a simpler and easier to understand mode of information transmittal. Getting and disseminating information has never been easier because we are a technology driven society. A whopping ninety-seven percent of us own a cell phone.

We can use our cell phones to measure steps taken, stairs climbed and even hours slept. Imagine what would happen if people could easily check blood glucose levels as easily as the number of steps taken during the day. Anyone using this technology would gain personal health information that would enable them to modify their lifestyles to keep glucose levels in the normal range.

Well, we no longer must imagine what would happen if people could easily check blood glucose levels as easily as the number of steps taken during the day as opposed to the cumbersome four decade old, finger stick tests used by most diabetics today. The technology is available. The question now is, “what will happen and who will have access to it?”

Multiple factors cause blood glucose level variation. Factors may be obvious or not so obvious. While you might expect that eating a super-sized order of French fries would raise your blood glucose, how about drinking a glass of water? No effect? Think again. Hopefully, you get the idea. Glycemic variability refers to the swings in blood glucose including episodes of high blood sugar levels (hyperglycemia) and low blood sugar levels (hypoglycemia). While fluctuation in blood glucose level is normal, swinging to extreme levels can be life-threatening.

Lifestyle is more than a catch phrase. In 2019, Americans spent $34.8B on gym memberships alone. That number decreased with the advent of COVID-19 but is starting to return. The numbers tell us that most Americans are interested in their health.

The sale of smart watches in the United States has increased from 9 million units in 2016 to 22.6 million units in 2020. When one combines the number of Americans interested in living healthier lifestyles with the burgeoning numbers of smart phones and smart devices, you have an environment ready for easy and rapid blood glucose monitoring without the need of a laboratory test or even a finger stick.

Being able to translate the effects of activity, diet, hydration, and stress on one’s blood glucose levels in real time has the potential to prevent millions of pre-diabetics from progressing to full blown disease. It also has the potential to help those diagnosed with diabetes to gain better control of their blood sugar.

There is no cure for Type 2 diabetes, but it is possible to ameliorate the negative effects of the disease with better regulation of blood glucose levels. Lifestyle modification is one of the most effective ameliorating factors. It has been shown that making simple alterations in lifestyle has the potential to eliminate the need for medication.

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According to Dr. Alexander “Zan” Fleming, Founder and Executive Chairman of Kinexum, utilization of continuous glucose monitoring (CGM) technology affords “huge potential value for healthy people by allowing them to easily see their blood glucose levels during every day activities. In addition, people who are struggling with obesity risks, who need to and already should be aware of their blood glucose levels, CGM data will be a welcomed and invaluable resource for them.”

With innovation comes challenge. The first challenge regarding diabetes technology is transforming that which is available to that which is accessible. The second challenge is achieving adoption of that technology because even the best tools in world will rust if they go unused. Only by eliminating barriers to access will those in need benefit. Next, accessibility to a technology does not immediately result in adoption of that technology. Adoption of any modern technology requires the education of both health care providers and the public at large about the risks, benefits, and alternatives of use. With the free flow of accurate information, adoption will be more likely.

The marketing of continuous blood glucose monitoring (CGM) systems is underway both here and in Europe. In the United States, Abbott is marketing their FreeStyle Libre CGM systems. One of their models replaces the finger-stick with an implanted wire attached to an external device attached to the upper arm. Users place a monitor or their cell phones next to the external device to obtain a reading. The Galien Foundation, a celebrated global institution dedicated to honoring innovators in life sciences, named Abbott’s FreeStyle Libre CGM technology as the “Best Medical Technology” with its Golden Jubilee Awards, recognizing global innovations deemed to have had the greatest impact on society.

While the technology is certainly praiseworthy, it is having only a minor impact on the diabetes pandemic. In a September 28, 2022, press release, Abbott announced that “nearly 3.5 million people across more than 50 countries” were using the FreeStyle Libre CGM system. (Remember that the United States alone has an estimated 45.8 million diabetics and an additional ninety-six million pre-diabetics.) Simply stated, availability is different from accessibility and accessibility is different from adoption.

Dexcom is marketing a technology for CGM under the name Dexcom G6 CGM. Like the Abbott device, the Dexcom system requires insertion of a slim sensor wire under the skin using an automatic applicator. An adhesive patch holds the CGM device in place so it can measure glucose readings. The device’s abdominal wire connects to a reusable transmitter. A variety of iOS and Android smart devices are compatible with the Dexcom G6 app. The device is customizable for high- and low-level alerts and generates a daily events log. Up to ten people can follow the user’s glucose readings. However, if symptoms or expectations do no match readings, it may be necessary to obtain finger stick readings before making diabetes treatment decisions.

(Both the Abbott and the Dexcom systems use technology that measures glucose levels in interstitial fluid just below the skin surface. Interstitial fluid is the fluid between cells.)

Dexcom announced that it has “approximately 900,000 people across the globe wearing a Dexcom CGM today.” The number includes patients with both Type 1 and Type 2 diabetes. Dexcom faces the same problem as Abbott in that availability has not translated into accessibility. The greatest obstacle to achieving better accessibility for both companies is the Byzantine FDA approval process itself. Bringing a medical device to market is not a fast process, getting approval takes an average of 3 to 7 years.

The next hurdle is convincing clinicians to utilize innovative technology. This hurdle is in part due to the health care reimbursement system which resists change even if those changes prove to have better health outcomes and are more cost effective. Clinical inertia is a real phenomenon.

Factors that contribute to resistance of recent technology adoption include the belief that the technology will interfere with the ability of care providers to make independent diagnoses and that it will interfere with the doctor-patient relationship. Some fear that technology will lead to ceding physician control to management. In contrast, other medical staff welcome technology because it provides more opportunities for patient-staff interaction.

Acceptance of modern technology from the patient’s perspective presents different challenges. Without adequate patient education, adoption, and utilization falls. To increase the use of innovative technologies, potential users must first understand the health data produced in the context of their personal health. The devices must be easy to use and easy to integrate into everyday life. Thus, users need to know how to manage their own data.

In simple terms, users must first know that the technologies are available and accessible at a reasonable out-of-pocket cost. Equally important is understanding the benefits accrued through device utilization in terms relating to the achievement of better personal health.

For those of us who have ever tried to: eat healthier, eat less, exercise more, drink more water, or take our medication as prescribed, the information provided by CGM may be the answer to preventing or slowing the progression of diabetes. We do not fault someone for not knowing what they do not know, but not knowing no longer needs to be the case when it comes to blood glucose levels. Being able to easily access this CGM provides an invaluable tool for us to lead healthier lives and to prevent progression from a pre-diabetic state to full blown diabetes. In short, information is lifesaving.

The diabetes pandemic is raging yet it is not getting the attention it deserves. Because diabetes kills by an accretion of injuries, it is not raising alarms like those of Covid-19. That fact does not diminish its lethality. In 2021, almost 7oo,ooo American deaths were attributable to diabetes. One of the best ways to address this issue is through the more efficient transmission of health care information.

The FDA has both pioneered and screened lifesaving technologies; however, its current bureaucracy erects too many barriers for real-time accessible innovation and only through the dissemination of information can we hope to live healthier lives. Dr. Fleming believes that “the FDA is open to the use of general GCM products especially devices that don’t require penetrating the skin, for supporting wellness and lifestyle objectives.” We should hope he’s correct, because it’s time to reduce the hurdles in accessing information about diabetes and this time it’s the FDA’s move to act by acting less.

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