13 Diabetes Products in the Pipeline
Welcome to the future of diabetes management
Innovation is moving faster than ever, and that’s true in the diabetes world, too. Each year, new products are pushed out of the pipeline in the hopes of making diabetes management easier and more accurate. Here are some we eagerly await.
There’s been talk about Medtronic’s latest combo continuous glucose monitor (CGM)–pump, but lost in all that chatter is that the company has set its sights on a device for people taking multiple daily injections, too. Enter the Guardian Connect, a stand-alone continuous glucose monitor (not connected to a pump). Every five minutes, the CGM will transmit a reading to a smart device (Apple first; Android later), where you can view data or send readings and reports to family, caregivers, or a health care provider. The device will connect with the Sugar IQ app, which uses IBM’s Watson supercomputer to mine the data and provide insight—say, your glucose trends low around 3 p.m. each day. Guardian Connect is currently under review by the Food and Drug Administration (FDA).
To reach its goal of a partial artificial pancreas—a system that will automatically deliver basal insulin and bolus correction doses—by the summer of 2018, Tandem Diabetes is teaming up with CGM manufacturer Dexcom for a three-part project. First comes the integration of Dexcom’s G5 sensor with Tandem’s T:slim X2 pump. FDA clearance is expected by midyear. After that: an X2 pump with CGM integration that tracks glucose trends, then stops insulin delivery before your glucose drops too low—estimated to release by the end of the year. But the big deal is a pump that does all of the above, plus uses CGM data to automatically deliver basal insulin and bolus correction doses when your glucose rises. You’d still need to enter carbs and bolus for meals. If all goes according to plan, that could be on the market by June 2018.
Common Sensing’s Gocap can log doses from any disposable, prefilled insulin pen. Attach it to your pen and, using optical sensors, it will determine how much insulin you’ve delivered. Doses are displayed on the screen and automatically logged, making it easy for you to share with your provider and family. Other features include wireless communication with certain meters and an app that helps translate your dosing and blood glucose data so you can better manage your diabetes. Pilot clinical studies are underway, and the cap is expected to be available through certain insurance plans sometime this year.
Another memory tool for insulin pens is in the early design stages. Insulog uses sensors to determine how much insulin you’ve taken—and when. The device snaps onto the side of an insulin pen and displays information on a digital screen. It also streams data via Bluetooth to a companion app.
Dexcom is teaming up with Verily (the life sciences division of Google’s parent company, Alphabet) to create a disposable continuous glucose monitoring system for people with type 2 diabetes. Over the course of its 14-day lifespan, a sensor would send your readings to a smartphone app so you can easily share with family or your health care provider. At launch, the above-skin portion of the sensor will be smaller than a quarter, but by 2020 the company hopes to have reduced it to the size of an M&M candy. An added bonus: The device won’t require finger-stick calibration. Dexcom sees the disposable CGM as a device people with type 2 could use as needed for greater insight into their glucose levels—say, with diet or exercise changes. The system is expected to release in 2018.
One of the elusive goals of insulin research is developing a pill you can take daily. There’s just one problem: Because insulin is a protein-based drug, the stomach digests it before it has time to do your blood glucose any good. Professor Mary McCourt, PhD, and her team at Niagara University are working on a solution. They theorize that by putting insulin into a container made of molecules the stomach won’t break down, they can create an insulin pill that’ll pass through the stomach. Their technology, named Cholestosome, uses naturally occurring lipid molecules—the building blocks of fats—to create cavities that can hold the insulin. Because of its makeup, Cholestosome can resist breakdown by stomach acid as it passes through the stomach. Once in the intestines, Cholestosome is absorbed, and insulin is released. The researchers are in the early stages of development, and more animal studies are ahead.
Not a fan of replacing your CGM sensor every week? In the future, you might go as long as three months between sensor changes. Senseonics’ system includes a 90-day, pill-sized sensor that’s inserted beneath the skin of the upper arm and a removable transmitter (a bit larger than traditional CGM transmitters) that rests just above, on top of the skin. Using fluorescent technology, the sensor monitors glucose, then wirelessly sends the data to the transmitter. That, in turn, sends data to a smartphone app. Sensor insertion and removal is done by a doctor during a short office visit. Within 24 hours, users can begin getting readings, and within 48 hours the insertion site will be fully healed. The CGM is currently available in Europe and was submitted to the FDA for premarket approval in late 2016. The goal: a U.S. launch by the end of this year or early 2018.
Tubeless Artificial Pancreas
Insulet is conducting clinical trials for its Omnipod Horizon partial artificial pancreas system that’ll run on its tubeless pump and with a CGM sensor—the company hopes to use Dexcom’s next-generation G6 version—and an Android-based handheld receiver to control functions. The system, which users will be able to customize using the handheld device, automatically controls basal insulin, though users will need to manually deliver mealtime boluses. Testing on the system has already begun, and in 2018 Insulet plans to conduct a pivotal trial, with a product release tentatively scheduled for 2019.
In the pipeline for people with type 2: a lower-tech insulin delivery option from Becton, Dickinson, and Co. The disposable device delivers both basal and bolus insulin directly from a patch that’s worn on the skin for up to three days. A Bluetooth receiver wirelessly communicates with the device and relays information to a smartphone app. Look for it in 2018.
Long-term high blood glucose can deprive the retina of oxygen and cause growth of weak blood vessels that leak, all of which impairs vision. The current treatments for the condition, known as diabetic retinopathy: injectable drugs, laser therapy, and surgery. But in the future, you may be able to treat it while you sleep. PolyPhotonix’s Noctura 400 Sleep Mask emits low-level light through your eyelids during slumber, which the company claims reduces the amount of oxygen the eyes need during the night and minimizes the growth of weakened vessels. (More research is needed to determine whether this technology can effectively treat diabetic retinopathy.) Right now, it’s available only in the United Kingdom, but PolyPhotonix has submitted the product for FDA review.
These products are just around the corner
Medtronic MiniMed 670G
This is what you’ve been waiting for: a partial artificial pancreas, a hybrid closed-loop insulin pump that automatically adjusts your basal insulin delivery based on your glucose level. (You still need to manually bolus for meals, though.) The system, which includes a more accurate CGM sensor, has received FDA approval and is set to launch this spring.
Both insulin degludec (Tresiba) and liraglutide (Victoza) have been out on the market for years. Now Novo Nordisk is combining the two in a mix that will treat type 2 diabetes in a new way. The FDA has approved the injectable drug, Xultophy, and it’s set to release by midyear.
OneTouch Vibe Plus
The FDA has cleared Animas’s latest insulin pump, which is integrated with Dexcom’s G5 Mobile CGM system. Download Dexcom’s app onto a smartphone to get glucose readings, trends, and to program the pump to deliver insulin. Friends, caregivers, and health care providers using another app can see your real-time glucose data. No word yet on the product’s specific launch date.