Top Tech on the Horizon 2014
7 products-to-be offer a look at what’s coming in diabetes care
Take a peek into the future of diabetes care with seven in-development products poised to make waves in the diabetes world. All except BlueStar were unavailable in the United States as of Oct. 1, 2013—the cutoff date for inclusion in this guide.
When you live with diabetes, you get used to carting around a ton of stuff—meters, test strips, lancing devices, and so forth. But a pocket-sized gadget may streamline all that gear. LabStyle Innovations’ Dario diabetes management system is a blood glucose meter with a built-in lancing device and a pull-out compartment that holds 25 test strips. A small piece of the Dario detaches from the meter and connects to a smartphone headphone jack, linking the meter to a Dario app.
After logging into their Dario app, users simply turn a knob to eject a single test strip from the body of the meter, insert the test strip into the connection device attached to the smartphone, add a drop of blood, and wait for the app to display the blood glucose level on the phone screen. The Dario app also allows users to log carbohydrate intake and exercise, search a food database, track insulin injected, calculate insulin doses, graph glucose data, and send reports to family and caregivers. The Dario meter-app combo is expected to be available in Europe in early 2014.
Last year saw the arrival of a new type of pump—a simple, tubeless device created specifically for people with type 2 diabetes—when the Valeritas V-Go patch pump became available. A cross between insulin pumps and insulin pens, patch pumps are being developed for people with type 2 who don’t require the added features traditional pumps provide but whose blood glucose control might benefit from continuous insulin infusion. Those are the people CeQur is targeting with its PaQ pump, which can be worn for three days. The circular, palm-sized pump consists of a disposable insulin infuser that delivers preset basal and bolus doses and a reusable messenger unit that notifies users when it’s time to replace the device. PaQ will be available in Europe beginning in 2014.
With Abbott’s Flash Glucose Monitoring System, the diabetes device arena will soon welcome a new product category that rests somewhere between blood glucose meters and continuous glucose monitors (CGMs). The idea is simple: Users wear a sensor under the skin for 14 days—no finger-stick calibration required. The sensor collects continuous glucose data from the interstitial fluid just beneath the skin’s surface. Using a handheld, color touch-screen reader device, users can scan the sensor patch to reveal real-time glucose values, trend arrows, and eight-hour trend graphs.
The device isn’t pitched as a CGM alternative, though. Unlike CGMs, the Flash Glucose Monitoring System won’t alert users to high or low glucose values with programmable alarms. Instead, Abbott sees its new product as an alternative to traditional blood glucose testing that does away with constant finger sticks and gives a visual glimpse at a person’s glucose trends. Pending the outcomes of clinical trials, the product is expected to be released in Europe by the end of 2014. No word yet on its expected availability in the United States.
Two in One
Many people with diabetes like the idea of using both an insulin pump and a continuous glucose monitor (CGM)—in theory. When they consider caring for two insertion sites, their enthusiasm shrinks. Medical supply company Becton, Dickinson (BD) and JDRF are collaborating on a device that would include a single infusion catheter to deliver insulin and a sensor to continuously monitor glucose. How a device like that might work is still more of a concept than reality.
The focus of the effort will be to determine exactly how close an insulin-delivering catheter can be to a CGM sensor without affecting accuracy. And the million-dollar question: How will product developers get around the fact that insulin infusion sets need to be changed every three days while CGM sensors can last up to a full week? Right now, researchers are beginning exploratory work in animals that will look at those questions and more, such as whether the use of a micro needle will accelerate insulin absorption for combo device users.
Help in a Hurry
Biodel’s glucagon device speeds the preparation process for lifesaving glucagon—and minimizes confusion. Traditional glucagon kits require users to inject liquid from a syringe into a vial of glucagon powder, shake the vial until the liquid turns clear, and withdraw the liquid into the syringe before injecting. Biodel’s innovative glucagon pen cuts the complex instructions by more than half. Here’s how it works: Twist the body of the pen to mix the powder and liquid held inside, remove the needle shield, inject, and press the plunger to deliver the dose. The needle automatically retracts once glucagon is delivered. Biodel plans to file for Food and Drug Administration (FDA) approval of the device in 2015.
Insulin pens that remember your last dose come in handy during moments when you can’t quite remember how much insulin you took—or how long ago. But such technology isn’t available in pens that allow for half-unit dosing. That’s changing: Novo Nordisk’s NovoPen Echo reusable insulin pen features half-unit dosing and a memory function that records your last insulin dose and how much time has passed since your injection. [Update: The pen is now available.]
Wireless Therapy [NEW!]
The first diabetes management product in the new FDA category of mobile prescription therapy is BlueStar by WellDoc. Such products, which deliver customized self-management advice 24-7 to a variety of mobile and Internet-enabled devices, are very different from unregulated health information and tracking apps. Mobile prescription therapy products require a prescription, must comply with federal privacy rules, and must demonstrate safety and effectiveness in clinical trials.
BlueStar is indicated for adults 21 or older with type 2 diabetes who are not on an insulin pump and are not pregnant. Think of it as a daily, real-time virtual coach. The automated system responds to the data you enter about taking medications, checking blood glucose, eating, exercise, and other actions, with tailored instructions and suggestions that show up on your smartphone. Say you enter a blood glucose reading of 66 mg/dl. You’ll see information on how to treat the low, and the product will display a reminder for you to recheck in 15 minutes. You may be prompted to enter information that will help you and your provider figure out why you went low. Meanwhile, your physician receives suggestions, if needed, about altering your diabetes therapy. He or she can communicate instructions to you by e-mail or phone or discuss potential changes with you at your next scheduled visit. The system is not able to respond to emergencies.
Before using BlueStar, the patient has face-to-face training with a certified trainer, who will set up the mobile prescription therapy on your smartphone and computer and show you how to use it. BlueStar is available in Maryland, and the company plans further regional rollouts.