8 Diabetes Products on the Horizon
The future of diabetes care is closer than you may think
Closing the Loop
When it comes to diabetes devices, the grail is a closed-loop system that will monitor glucose and make insulin adjustments in response. Bigfoot Biomedical believes its hybrid closed-loop system (above) could be the answer. Using the company’s own insulin pump, Abbott’s FreeStyle Libre continuous glucose monitor (CGM), and a smartphone app, Bigfoot’s device will be a closed-loop, automated insulin delivery system. Pivotal trials in the United States will be announced late this year. After those are completed—most likely in 2019—and pending Food and Drug Administration (FDA) review and approval, the automated system could hit markets in 2020. The company also has a Bluetooth-connected insulin pen in development, which uses the FreeStyle Libre and a mobile app to track and automatically adjust recommended basal and bolus insulin doses. Look for that pivotal trial to begin this year, too.
More Closed-Loop News Ahead
Insulin pump manufacturer Tandem Diabetes Care and digital health company TypeZero Technologies have just completed a pilot study of their hybrid closed-loop system, which uses the T:slim X2 insulin pump, TypeZero algorithm, and Dexcom G6 CGM to automatically adjust basal insulin throughout the day. The system will also automatically deliver correction boluses, though mealtime boluses are still delivered manually. Another trial of the system will take place this year. The goal: FDA approval and a release of the device in 2019.
Another CGM may soon be offering continuous glucose monitoring from your smartphone. Rather than communicating with a separate receiver, the WaveForm Continuous Glucose Monitoring System’s transmitter will send glucose data via Bluetooth to a compatible Apple or Android smart device. A downloadable app will collect glucose data, track trends, provide custom alerts, create charts, and allow users to share data within the app. The smaller CGM sensor diameter—about half the size of currently available sensors—makes for a quicker warm-up and allows users to wear it in more spots on the body. At launch, sensors will last for 14 days before they need to be replaced and rotated, but future generations might last even longer. Clinical trials in Europe have been completed, and the CGM will likely hit European markets late this year. The company has planned pivotal clinical trials for this year to support an FDA submission for future U.S. sales.
The Dexcom G6 CGM (still pending FDA approval at press time) will boast changes to nearly every part of the Dexcom experience. It starts with the G6 sensor, which is applied with a single button press, making insertion quick and painless. The sensor’s technology is updated, too: It requires just one calibration per day, and the company has plans to release a calibration-free sensor later this year. The accompanying transmitter lasts 90 days and is reusable, Bluetooth powered, and 30 percent smaller than the G5 version. A newly revamped receiver, which has already begun shipping to some users, includes a touch screen. The device and Share app may be familiar, but Dexcom reps say users will see improvement in design and flow. And pump users will be glad to know that the G6 will be compatible with future versions of Insulet’s and Tandem’s insulin pump systems. What’s staying the same? Like the G5 Mobile, the G6 won’t require finger sticks to make treatment decisions, and it still offers the option of using a smartphone in place of a CGM receiver.
Predict and Prevent
Tandem insulin pump users may soon be able to rest easier, as planned updates to the T:slim X2 insulin pump will include a feature that suspends insulin delivery when the pump predicts a user’s glucose is about to go too low. The new predictive low glucose suspend feature will be downloadable for free via Tandem’s Device Updater—no new pump necessary. Using the T:slim X2 pump and an integrated Dexcom G5 CGM, the predictive low glucose suspend algorithm will pause insulin delivery when the device predicts a blood glucose of less than 80 mg/dl in the next 30 minutes. The system responds to CGM readings and will resume insulin delivery once glucose levels begin to rise. The algorithm is currently in a pivotal trial, and Tandem hopes to submit it for FDA approval this year. The company is prepared to launch the device as early as this summer, pending the approval.
SugarBeat is hoping to change the CGM game with a device that uses a stick-on patch, not an under-the-skin sensor. The adhesive patch, about the size of a coin, sticks to skin and reports glucose levels (the company is tight-lipped on how, exactly, the device collects glucose data through the skin) every five minutes for 24 hours. A new patch is applied daily. A connected, rechargeable Bluetooth transmitter sends readings to a receiver or smartphone app. The device must be calibrated once daily with a finger stick. A European launch is planned for this year. The company plans to submit the device for FDA approval later this year.
Insulin in a pill? For years it seemed like a pipe dream, but at the end of 2017, Israeli company Oramed was gearing up for its phase 3 U.S. trial to deliver insulin via a pill. The concept was tricky: Stomach acids destroy the protein before it reaches the blood. But Oramed’s pill is absorbable from the intestine and is thought to act primarily on the liver, which regulates the insulin’s release. Under the conditions studied in the drug’s phase 2B trials, users saw effective blood glucose management without hypoglycemia. Once the phase 3 trial is complete, the company can submit the drug for FDA approval.
New and Improved
Further streamlining its tubeless, waterproof pump system, Insulet is developing the Omnipod Dash. The new system will see an update to the personal diabetes manager (PDM), the handheld device that connects with the pod to set basal and bolus rates. The current PDM is made by Insulet, but the Omnipod Dash’s PDM will be an Android smartphone—locked so it retains only pump functions, not apps or the ability to make calls—that will control insulin delivery and communicate via Bluetooth with the Contour Next blood glucose meter. Bluetooth is a big update for the Omnipod Dash system and will, Insulet hopes, open the door for cloud storage and communication between the pod and other devices, including continuous glucose monitors, in-the-works user and caregiver apps, and the ultimate goal: users’ personal smartphones. Because the Omnipod Dash is an improvement on an already existing device, Insulet isn’t required to conduct additional clinical trials before submitting to the FDA. The Omnipod Dash system should be available in limited U.S. markets this year, pending FDA approval this spring, with full availability three to six months after that. Insulet hopes to have a program allowing the pod to communicate with Dexcom CGMs in 2020.