14 “Next Big Thing” Diabetes Care Products
Products in the pipeline suggest big things to come
When you're dealing with the day-to-day management of diabetes, innovation may seem slow—much, much too slow. But compare today's tools with those from a decade or two ago, and it's clear just how far we've come. If the concepts and products on these pages are anything to go by, the next decade may see some of the most exciting innovations yet.
1. Seeing Is Believing
Anyone who's spent any amount of time doing finger-stick blood glucose tests will appreciate the vision of a new partnership. Tech giant Google and contact lens manufacturer Alcon (a division of the pharmaceutical company Novartis) are joining up to create a contact lens that measures the glucose in tears (pictured above). It will work something like this: A super-small sensor and thinner-than-hair antenna will be embedded between two soft contacts. A small hole in the lens will let tears reach the sensor, which will determine a glucose value—once per second if the researchers get their way. That data will wirelessly transfer to a mobile device for monitoring. Though researchers have conducted human trials on what the companies are calling the "smart lens," there's still a long way to go. As of this printing, there's no timetable for the product's release.
2. Bedside Diagnosis
Fasting blood glucose tests are great for diagnosing diabetes, but they skip one important detail: whether a person has type 1 or type 2. A team at Stanford University seeks a more specific diagnosis. Their innovative chip measures autoantibodies in the blood, which means it can differentiate between types of diabetes. That's an important factor because many adults are misdiagnosed with type 2 when they really have type 1. The process is simple: Take a drop of blood and get a result. The chip and corresponding reader are still in development, and clinical trials are launching to test their accuracy. IGI Stat, a company started by the Stanford researchers, hopes to see the device in hospitals in less than two years, pending Food and Drug Administration (FDA) clearance.
3. Fewer Finger Sticks
Current continuous glucose monitors (CGMs) on the market make it easy to see glucose data in real time, but a major complaint users have is the need for finger-stick confirmation and calibration. Abbott plans to change that with its FreeStyle Libre Flash Glucose Monitoring System, which doesn't require calibration with a blood glucose meter. It only uses finger-stick tests to confirm readings below 70 mg/dl, when your glucose is changing rapidly, or if your symptoms don't match your reading. A small, round sensor with a beneath-the-skin filament sits on the back of the arm, held in place by an adhesive pad. The sensor measures glucose levels in the fluid beneath the skin every minute.
Where a traditional CGM streams those data to a handheld monitor or pump, the Libre divulges data on command: The user scans the sensor using a handheld device, which even reads through clothing. A scan will reveal real-time readings, glucose trends, and information on whether glucose is rising or falling. The device can store up to 90 days of data, so users can view a snapshot of their glucose trends. The product has launched in select European countries. The company is working with the FDA to develop a plan to meet U.S. medical device requirements and has launched another clinical trial on the product. So far, Abbott has not released a timetable for the device's launch stateside.
4. Forget Me Not
You took insulin this morning—or maybe you didn't. Sound familiar? If you have trouble remembering whether you've delivered a dose of insulin, you're not alone. But forgetting whether you've injected insulin can be a dangerous thing. Miss a dose and your blood glucose will run high. Take an extra dose, and you could have a serious low.
Some insulin pen manufacturers address this issue by adding a digital memory function to their pens, but if you prefer a different insulin or pen type, you're out of luck. Enter Timesulin. The idea is simple: Once you snap the Timesulin cap on your pen, the timer starts. Not sure when you last took a dose? A glance at the digital reader will tell you just how long it's been since you last uncapped your pen. It works with most major pen brands. Timesulin is now available in the United States and can be purchased at timesulinus.com.
5. Deep Breath
For most intensive insulin users, multiple daily injections top the list of diabetes gripes. And while syringes, pens, or infusion sets are the only way to take long-acting insulin, Sanofi and MannKind Corp. may soon offer an alternative for rapid-acting insulin. Afrezza is an insulin powder that's inhaled at the start of each meal using a device similar to an asthma inhaler. The medication is quickly absorbed into the bloodstream so it works faster than injected rapid-acting insulin. It also seems to clear from the body more quickly, which could possibly reduce the risk for hypoglycemia. Because it's an inhaled drug, it shouldn't be used in people who smoke or those with chronic lung disease (such as asthma) or chronic obstructive pulmonary disease. Afrezza is now available for type 1 and 2 diabetes by prescription.
6. Hidden Needles
Researchers at the Massachusetts Institute of Technology have developed a pill with hollow needles (at left) that can inject a drug directly into the stomach lining once the capsule has been swallowed and its outer coating dissolved. The approach is still in its infancy, but it could provide another way to deliver insulin.
7. Smart Insulin
Pharmaceutical giant Merck has begun Phase 1 trials on what's being called "smart insulin." The drug will go into action when blood glucose is too high, then turn off when glucose returns to a safe level.
8. Double Duty
Research is underway on a dual hormone artificial pancreas that uses a continuous glucose monitor and two pumps—one for insulin, the other for glucagon—that work to measure and regulate glucose levels.
9. Under Your Skin
In the quest to create a less-intrusive way to take medicine, Intarcia is looking beneath the surface. Beneath your surface. The company's ITCA 650 is a matchstick-sized device (at left) implanted under the skin that delivers a continuous dose of the type 2 medication exenatide. But while exenatide is traditionally delivered via twice-a-day or once-weekly injections, the ICTA 650 would need to be implanted only once or twice a year. The device is currently in Phase 3 trials in humans, and the company plans to file for FDA clearance early next year.
10. Winning Combination
An injectable type 2 medication launching soon in Europe may be heading stateside sometime in the future. Xultophy, a mix of the ultra-long-acting Tresiba (insulin degludec) and injectable type 2 drug Victoza (liraglutide), is injected once daily for blood glucose management. While the drug's expected to hit European markets in the first half of this year, Americans with type 2 will have a longer wait. Tresiba—an essential element of Xultophy—was not approved by the FDA after submission in 2013. Manufacturer Novo Nordisk is conducting trials on Tresiba's cardiovascular side effects and hopes to decide when to submit the drug to the FDA based on trial outcomes.
11. Automated Operations
Ask Medtronic for a peek at its future tech, and you'll get a glimpse of some truly innovative devices, starting with the 640G, a combination pump and CGM. The pump will suspend insulin delivery based on predicted low glucose readings and resume delivery once levels have risen. It goes a step beyond the year-old 530G, a CGM-pump combo that stops insulin delivery once a user's glucose level hits a low limit. This also marks the introduction of a more modern design for Medtronic devices. The combination CGM-pump is available now in Australia and set to launch in the United States this year, pending approval.
12. Kicking Lows to the Curb
Glucagon raises blood glucose from the danger zone, but the need to mix the formu la wastes precious time needed to treat a hypoglycemic person. Xeris Pharmaceuticals is developing premixed glucagon, which it intends for use in full-sized pens, mini pens, and insulin pumps. Unlike glucagon products that treat severe hypoglycemia (when blood glucose is so low a person requires the assistance of others), the G-Pen Mini will be self-administered, delivering a smaller (customizable) dose of premixed glucagon. The goal: a calorie-free alternative to current glucose-raising products. The device will begin a second Phase 2 trial next year, with the goal of a 2017 release for children and adults with type 1 or type 2 diabetes.
13. Peace of Mind
Sharing CGM data is a growing trend with two FDA-cleared products now available. Medtronic's MiniMed Paradigm Real-Time Revel pump transmits CGM data to mySentry, a device that allows for viewing of glucose data from up to 50 feet away. That means sleepy parents can monitor trends during the night from their beds.
14. Data Sharing From Afar
The next evolutionary step: sharing data across more than 50 feet. That's where the Dexcom Share comes in. Slide your CGM receiver in the docking station, and the device will wirelessly transmit CGM data to your iPhone or iPod Touch.
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