Noninvasive Monitoring Devices For 2019
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.