News Flash: The FDA Just Approved a Breakthrough Diabetes Device

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Diabetes is often referred to in the medical community as the "silent killer." Affecting more than 30 million people in the U.S. (9.4% of the population), diabetes was listed the cause of death for nearly 80,000 people in 2016, according to the Centers for Disease Control and Prevention. Its comorbidities, such as hypertension, heart disease, and kidney disease, can also cause lifelong problems and themselves lead to death. Though it may not inspire the same fear in patients as a cancer diagnosis, it's a very serious disease.

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Diabetes is also a costly disease to treat. The CDC's National Diabetes Statistics Report released earlier this year estimated the direct and indirect estimated costs of diagnosed diabetes at $245 billion as of 2012. Mind you, nearly 24% of the 30.3 million people with diabetes in the U.S. are undiagnosed, meaning this $245 billion estimate is probably conservative and underrepresenting the actual costs of treating diabetic patients. It probably also fails to fully account for the lost worker productivity as a result of diabetics missing work or passing away earlier than people who don't have diabetes.

These statistics demonstrate why research into new medicines and devices designed to improve the quality of life of diabetics is so important.

The FDA green-lights another breakthrough diabetes device

Well, folks, I have some good news to report. Last week, the Food and Drug Administration approved a breakthrough diabetes device from Abbott Laboratories (NYSE: ABT) that should make life considerably better, and less painful, for diabetics. 

The device, known as the Freestyle Libre Flash, is a continuous glucose monitoring system that doesn't require adult diabetics to prick themselves with a needle to take blood glucose measurements on a regular basis. Instead, Freestyle Libre Flash uses a small wire inserted under the skin to determine glucose levels. Users then wave a mobile reader above the sensor wire to determine if their glucose levels are too high or too low and can utilize the sensor to monitor how their glucose levels change throughout the day. Following a 12-hour start-up period, the device can be worn for up to 10 days.

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The approval of Abbott Labs' device isn't a complete shock, given that Freestyle Libre Flash was already approved in Europe and Canada. However, it should be rapidly adopted in the U.S. based on data the company provided at the Advanced Technologies and Treatments for Diabetes conference earlier this year. At this conference, Abbott Labs announced that data from more than 50,000 Freestyle Libre Flash users showed they were checking their blood glucose levels an average of just over 16 times a day. This was considerably higher than patients who have to prick their fingers to measure their blood glucose levels, suggesting that a healthier patient and higher demand could be around the corner.

Breakthroughs are becoming commonplace

Of course, Abbott Laboratories' approval isn't the only major advancement that diabetics have seen in recent years. A year ago, Medtronic (NYSE: MDT) introduced what could be the biggest breakthrough ever for type 1 diabetics, a group that includes those who have little or no insulin production from their pancreas, and often have diabetes because of genetics or specific viruses.

The MiniMed 670G is the world's first FDA-approved closed-loop system to measure blood glucose levels and administer insulin on an as-needed basis. The device uses a sensor with a protruding needle that's slipped under the user's skin and measures blood glucose. What's particularly intriguing about the MiniMed 670G is that it should reduce the potential for hypoglycemia from the over-administration of insulin. 

We've also seen tech kingpin Apple (NASDAQ: AAPL) working on a non-invasive glucose-measuring device that works hand-in-hand with the Apple Watch. In May, CEO Tim Cook was spotted wearing the device. This would mark the next step forward for Apple, which in June 2014 introduced its Health app for users to track various aspects of health and fitness data. 

Even the medicines diabetics have access to are taking giant leaps forward. SGLT-2 inhibitors, which work in the kidneys by blocking glucose absorption, and allowing the user to excrete excess glucose through the urine, have helped type 2 diabetics -- which comprise about 95% of all diabetes cases -- better control their blood sugar levels. They also come with the pleasant side effects of weight loss and lowered systolic blood pressure.

Lexicon Pharmaceuticals (NASDAQ: LXRX) currently has what could be a next-generation dual SGLT-1 and SGLT-2 inhibitor in development, known as sotagliflozin. The addition of SGLT-1 should help block glucose absorption in the intestines as well the kidneys (SGLT-2), possibly improving upon what SGLT-2 inhibitors bring to the table. With licensing partner Sanofi running late-stage studies involving sotagliflozin for type 2 diabetics, and Lexicon already reporting positive late-stage data for type 1 diabetics, we should know relatively soon if Lexicon's lead drug can offer new choices for all diabetics (type 1 and 2). 

Without question, diabetes is a serious disease. But we can be thankful that drug and device developers are stepping up to the plate with serious solutions.

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Sean Williams has no position in any of the stocks mentioned. The Motley Fool owns shares of and recommends Apple. The Motley Fool owns shares of Medtronic and has the following options: long January 2020 $150 calls on Apple and short January 2020 $155 calls on Apple. The Motley Fool has a disclosure policy.