12 Products in the Diabetes Pipeline
Innovation reigns when it comes to the future of diabetes management
The good news: Thanks to some smart thinking, the diabetes pipeline is packed with prototype products that aim to make your life easier. The bad news? Innovation takes time—and a lot of testing and clearing of regulatory hurdles before devices and medications make it to market. We’ve picked a dozen products that we think are worth the wait. Read on for a glimpse of the future.
If you’re sick and tired of clunky meters that scream “medical device,” you’re not alone. Jeff Dachis was so put off by the diabetes technology available when he was diagnosed with latent autoimmune diabetes in adults (LADA) 2½ years ago that he decided to create his own. His company, One Drop, has been offering its app on Apple devices (expect an Android version this year) and plans to add a blood glucose meter to the mix. The idea is similar to other subscription-based blood glucose monitoring programs, such as Livongo Health’s: Users pay a monthly fee and in return receive a One Drop meter, lancing device, carrying case, and unlimited test strips. The meter will wirelessly transmit blood glucose results to the free One Drop app, which will automatically log glucose readings—other data, including exercise, food, and medications, require manual input—and connect users via a social network. While the meter hasn’t yet been cleared by the Food and Drug Administration (FDA), the company is shooting for a release at the end of this year.
The company that gave us a pump that stops insulin delivery when glucose levels get too low is plotting two more devices that will come even closer to an artificial pancreas. Next up for Medtronic is the MiniMed 640G. While the currently available 530G uses a built-in continuous glucose monitor (CGM) to suspend insulin delivery when glucose levels hit a preset low value and you fail to respond to an alert, the next-generation pump predicts when glucose will hit a predetermined threshold 30 minutes before your glucose dips that low and stops insulin delivery. After two hours or when your glucose starts to rise from the low threshold, insulin delivery begins again. The 640G will usher in Medtronic’s new pump design and sensor. The company has finished a pivotal trial on the system in the United States and is currently prepping to submit to the FDA for clearance. Further down the pipeline is Medtronic’s hybrid closed-loop pump, which uses a built-in CGM to adjust basal (but not bolus) insulin on its own. Medtronic plans to send data on it to the FDA for review in mid-2016.
When low blood glucose is left untreated, it can lead to unconsciousness. Enter glucagon, a hormone produced in the pancreas that raises levels of glucose in the blood. The only option for delivery of a rescue dose is via an injectable solution that must be mixed right before it’s given. But an inhalable powder glucagon may be on its way. Eli Lilly and Co. is developing intranasal glucagon (formally in development by Locemia), given by a friend, family member, or caregiver when a person with diabetes is unable to self-treat with oral glucose. With the press of a plunger, the device delivers a puff of glucagon up the nose, where it’s absorbed into the nasal passages. The drug is currently undergoing Phase 3 clinical trials in adults and children, and the company is staying mum on when it plans to submit to the FDA.
4. Infusion set
When insulin delivery is blocked, your pump will sound an occlusion alarm. At least, it’s supposed to. But sometimes interruptions in insulin flow are undetected by an insulin pump, which can lead to high blood glucose. Becton, Dickinson, and Co. is hoping to sidestep that problem with its first insulin infusion set. Using BD’s FlowSmart technology—a catheter with an opening on the side as well as at the tip—the set improves insulin flow to cut down on the number of interruptions. The product will work with Medtronic pumps as well as those with Luer-lock connectors. A bonus: The infusion set uses a thinner needle to insert the catheter than others on the market. The FDA cleared the set last year, and it’s expected to launch in the United States this year.
A few years ago, the V-Go insulin delivery device hit markets as a lower-tech alternative to insulin pumps for people with type 2. Unilife hopes to give V-Go some competition with its Imperium patch pump, a prefilled, disposable insulin delivery device that prides itself on its simplicity: peel the adhesive backing, stick the pod to your body, and press a button to insert the needle or cannula and begin. Imperium combines a preset basal rate with bolus delivery via a button on the device’s body. Bluetooth connectivity means the pump can integrate with smartphone apps. But don’t expect to see a Unilife pump on the market—the manufacturer plans to partner with pharmaceutical companies, which will supply the insulin then sell the device as their own in much the same way insulin pens are filled and sold. Imperium has not been approved by the FDA.
Refrigeration of insulin can range from a frustrating inconvenience (say, if you’re struggling to keep your insulin cool while traveling) to a serious challenge (if you live in a sweltering part of the world, such as India, without access to a refrigerator). Researchers at Thermalin are hoping to bypass those issues with their ultra-heat-stable long- and rapid-acting insulins. Unlike the insulins available today, which retain peak potency an average of 30 days at room temperature if unopened, Thermalin’s ultra-heat-stable insulins can spend a year in body-temperature environments up to 115 degrees without losing potency. In testing, the insulins worked even after being boiled. The benefit to people in areas with limited access to refrigeration is clear, but the company sees another possibility: If the insulin can stay potent for months at body temperatures, an implanted closed-loop pump may be a future reality.
Convenience is king when it comes to Dexcom’s next-generation glucose sensor. If the CGM giant has its way, users will be treated to fewer calibrations (just once every 24 hours), which means fewer finger sticks, and fewer sensor changes (the company’s aiming for a device you can wear for 10 days). Also in development: a sensor applicator that reduces pain by using a single button press to attach the device to the body, plus a smaller transmitter. The ultimate goal is for a disposable, dime- or nickel-sized transmitter, which Dexcom hopes to create through its partnership with Google. As for the CGM system’s near future, look for an Apple watch app for the G5 Mobile system (not to be confused with Dexcom’s Share app) in the first half of this year and integration with Android devices in the second half.
Picture hundreds of thousands of beta cells trapped in a strip of perforated plastic and implanted in your body. Now imagine those cells can produce insulin in just the right amounts—and replace injections. That could be a reality if ViaCyte’s vision is realized. The company is currently testing its beta cell replacement therapy in a group of people with diabetes. While this Phase 1 and 2 trial will continue for two years, researchers will evaluate the safety and efficacy of the therapy after all participants have been treated for six months—some time around August 2017. Provided the treatment is safe and the implant is working well, the company will conduct one or more additional clinical trials before seeking FDA approval. For more on beta cell encapsulation, check out diabetesforecast.org/cellencapsulation.
Schlepping around a superabundance of diabetes supplies can be annoying, especially if you don’t carry an oversized handbag. Enter the SugarCube, a Bluetooth-capable blood glucose meter that stores test strips and lancets and stashes one of nine brand-name pens for easy delivery of insulin or a type 2 injectable drug. While blood glucose readings are visible on the meter face, the device is more useful with the SugarCube app, which logs glucose data (automatically for Bluetooth-capable meters, such as the SugarCube, or manually for others), tracks diet and exercise, and creates reports. An added benefit: The data sync to the cloud, allowing you and your doctor to view reports in real time. The app will be available on Apple devices this March and on Android devices come May. As for the SugarCube meter, the company plans to submit to the FDA in September and hopes to begin shipping in December.
If you love your insulin pens but want more pump-like functions—without sticking anything to your skin—you may be in luck. What’s currently being called the InPen looks like a traditional insulin pen and works like one, too—but it also links to a smartphone app. Insert a prefilled insulin cartridge (NovoLog- and HumaLog-ready versions will be available at launch) and get ready to dose. Download the app to move beyond the basics—you can view data on past doses, calculate a dose, set reminders, and more on a mobile device. Manufacturer Companion Medical has plans to partner with Glooko, Tidepool, and Dexcom data management software, but that probably won’t happen by the time the product launches. As for a release date, there’s none yet, but the company plans to submit to the FDA this year.
Another alternative to glucagon injections is a glucagon patch, currently in development by Zosano Pharma. Here’s how it works: A quarter-sized patch holds hundreds of drug-coated microneedles on its underside. Unlike glucagon injections, Zosano’s version uses a handheld device to apply the patch to the skin in a few short steps for a quick rescue. Once the patch is in place, the drug coating the needles dissolves into the fluid beneath the skin. A recently completed Phase 2 clinical trial found that the patch began working fast and normalized blood glucose as well as injected glucagon. With its Phase 2 trial a success, Zosano may start a pivotal Phase 3 clinical trial this year.
12. Management System
With health care providers in high demand, you might not get the hands-on care you want. Some companies are looking to bridge the gap with products and services that aim to make managing diabetes easier. Hygieia’s d-Nav system hopes to do just that with its prescription blood glucose meter, software for patients and health care providers, and d-Nav Care Centers.
The interplay between each aspect is what makes the system work: Nurses and clinical pharmacists at the center train patients (only adults, most with type 2, and not on insulin pumps) on the system and follow up regularly to conduct A1C tests and assess treatment changes. Those treatment changes are based on weeks of blood glucose readings collected by a meter that uses a special algorithm to adjust insulin therapy as needed. Rounding out the system is online software that connects patients and health care providers with glucose data. The company hopes American users will see the sorts of benefits its patients in the United Kingdom have—namely, a reduction in medications and lower A1Cs. Hygieia is currently conducting a National Institutes of Health–funded study in three U.S. cities, and it has plans to expand that in 2016 with the goal of a 2017 launch stateside.
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