8 Promising Diabetes Care Products in the Pipeline
Novo Nordisk’s NovoPen Echo Plus reusable insulin pen boasts several features designed to make dosing easier. While its predecessor, the NovoPen Echo, records only the most recent dose, the Echo Plus stores three months of injections—up to 800 doses—so you don’t need to keep a separate log. And a quick look at the pen’s tiny round screen will tell you when you took your last dose, so you won’t wonder whether you remembered to inject. All that data will allow you and your doctor to track patterns more successfully, which could help guide treatment decisions. But that’s not the only significant new feature: If approved by the Food and Drug Administration (FDA), the Echo Plus will also connect to a variety of diabetes-management apps and devices from partners Dexcom, Glooko, and Roche. More partnerships may follow. The company anticipates a U.S. release late this year.
Tandem insulin pump users, take note: A significant update to the T:slim X2 pump is expected this summer. The company’s Control-IQ software algorithm for automatic insulin delivery is currently in trials. If approved by the FDA, it will be the first system to correct elevated blood glucose levels by automatically delivering a correction bolus dose of insulin (you will still need to manually bolus for food). And it won’t require finger sticks to calibrate with your continuous glucose monitor (CGM). This is good news for those who use Dexcom’s G6 CGM: It will work in tandem (sorry, we couldn’t resist!) with the T:slim’s anticipated update. The company also has plans for a T:sport pump, a miniaturized, wearable version of the T:slim that will be controlled wirelessly via a separate handheld device, possibly a smartphone app. Look for a 2020 or 2021 release date.
Closing the Loop
Tech-savvy do-it-yourself enthusiasts have created a closed-loop system for insulin delivery, also known as an artificial pancreas, by linking CGMs to insulin pumps via a separate device and a free, open-source iPhone app. As many as 1,500 people with diabetes are estimated to be using it right now. It sounds exciting, but there’s a huge caveat: The system, called Loop, is not FDA approved, so it’s a hack that you use at your own risk. It also requires technical know-how and relies on outdated insulin pumps. Tidepool, a nonprofit dedicated to diabetes tech, has plans to change that. Starting in early 2020, Tidepool will begin a study of up to 300 current Loop users to demonstrate that the app that controls the system is both safe and effective. If the FDA approves it—no word on when that may happen—you’d be able to download the app (free for Apple devices) and pair it with the latest pumps and CGMs. So far, Tidepool has partnered with Insulet’s Omnipod DASH insulin pump and expects other companies to come on board in the near future.
A new, easy, and discreet way for adults with type 1 or type 2 diabetes to get mealtime insulin will likely be available the second half of this year. The 2.5-by-1.5-inch PAQ Meal patch pump, initially developed by Johnson & Johnson before the device was acquired by CeQur last year, is designed to be worn on your abdomen. Insert it once and then wear it for up to three days, including in the bath and pool. It holds up to 200 units of rapid-acting insulin (Humalog, NovoLog, or Fiasp). Press the two buttons on either side of the device—you can do this through your clothes—to deliver 2 units of insulin at a time. The company is also at work on a three-day patch, the PAQ Total, which will be used for both mealtime and basal insulin delivery. If approved, it’s expected to be available by mid-2021.
Lasering in on Glucose Levels
Noninvasive blood glucose monitoring may one day be a reality. Researchers at the Massachusetts Institute of Technology and the University of Missouri School of Medicine are collaborating on technology that uses laser light to scan a person’s skin. Shifts in the light’s wavelength indicate a person’s glucose level. The researchers tested their method, called Raman spectroscopy, on 20 people who did not have diabetes. They found that it was just as accurate as a finger stick. One of the lead researchers expects to see such noninvasive glucose sensors on the market in about five years. The sensors will likely be used in hospitals and other health care settings first, for patients unable to undergo frequent blood draws. Smaller, more portable versions may follow. Before any of that happens, though, the technology must be tested on people with diabetes.
Now In Pill Form
Last year, Novo Nordisk received FDA approval for its once-weekly injectable GLP-1 receptor agonist semaglutide (Ozempic). Now the company is closing in on a first-of-its-kind pill version. In a six-month randomized study, up to 80 percent of people taking the oral semaglutide saw their A1C levels drop below 7 percent. Meanwhile, only 34 percent of participants taking a placebo reached that benchmark. Another benefit: weight loss. Participants who took the highest dose of oral semaglutide shed 9 pounds, on average, while those given a placebo lost about one-third that amount. The most common side effect was nausea. The company hopes for approval by the end of this year.
Beta Bionics landed a grant from the National Institutes of Health late last year for up to $2 million toward the development of the iLet, which the company calls the first “bionic” pancreas. Designed for nearly hands-off blood glucose management, the iLet’s automated basal and bolus insulin delivery system is in home-use clinical trials right now, while adults and children as young as 6 with type 1 diabetes test drive it. Users can choose to pair the iLet pump with one of two compatible CGMs: the Dexcom G6 or Senseonics’ 90-day implantable Eversense. First up for FDA approval is an insulin-only version of the iLet, which Beta Bionics hopes to launch in 2020 for children and adults. The company is also pursuing an iLet capable of delivering both insulin and glucagon. The company anticipates its release, pending approval, about two years after the initial device.
Low blood glucose (hypoglycemia) can cause seizures, convulsions, and unconsciousness. Glucagon, which quickly raises blood glucose, is used to treat severe hypoglycemia when a person with diabetes can’t eat or drink. Currently, glucagon has to be mixed right before it’s injected. But ready-to-use solutions may be on the way: Xeris Pharmaceutical’s Rescue Pen and a nasal spray from Eli Lilly are both under review by the FDA with approval expected in mid-2019. And Denmark-based Zealand Pharma expects to submit its ready-to-use HypoPal pen, which it calls dasiglucagon, to the FDA later this year with hopes of a U.S. release by 2021, if approved.