By Wil Dubois, BS, AAS, PWD, CPT, TPT
Over the past quarter century, we’ve seen an explosion in the technology we use to treat diabetes: meters for home testing blood glucose, insulin pens, pumps, continuous glucose monitors, software, apps and more. Some years have given us game-changers, while other years have given us the same old gear — in a new color.
This year, we have new devices that talk to one another and to consumer electronics; new ways to share our health status with our loved ones; and new options for delivering insulin, treating diabetes-related pain, and viewing and analyzing our data. Here’s our lineup of some of the best new diabetes products, tools, and gadgets that have hit the market in the last year.
While we live the non-diabetes part of our lives in an increasingly connected world, up until recently, it was rare for diabetes devices to communicate with one another, much less with the non-medical devices that fill our ecosystems. Instead, our medical technology was isolated in proprietary silos.
Increased connectivity has long been the rallying cry of the Type 1 online community, a group described by Food and Drug Administration (FDA) device approval chief Stayce Beck as “large, well organized, thoughtful, and vocal.” The device makers apparently heard the noise, too, and have responded: 2015 may go down in diabetes history as the Year of Connectivity.
At the forefront of connecting its technology to both other medical devices and consumer gear is continuous glucose monitor (CGM) maker Dexcom. This California technology company has been innovating at lightning speed over the last few years, and this past year, it released the next-generation version of its core product, the G4 sensor system.
For background, in 2014, Dexcom rolled out a “Share” charging cradle that transmitted glucose data to the cloud when the CGM receiver was in the cradle, a device quickly adopted by parents to keep tabs on nighttime blood sugars of their children with Type 1. It did not, however, provide a solution to daytime remote blood sugar monitoring. But in 2015, Dexcom released a Bluetooth-enabled version of the G4 receiver called Dexcom G4 with Share. The new Share system sends sensor glucose readings and trends to Apple iPhones in real time, which then can be uploaded to the cloud to be shared with other phones or to an Apple Watch.
Meanwhile, right on the heels of this innovation, Dexcom received FDA approval for, and quickly rolled out, a whole new sensor system called the Dexcom G5. The G5’s transmitter itself is Bluetooth enabled, allowing users to bypass a receiver box altogether because the sensor data are beamed straight to an iPhone. Opinions are mixed, however, because the new transmitter is larger than its predecessor and much shorter lived. G5 transmitters have a three-month life and are designed to shut down after that time (G4 transmitters have an official six-month life, but are not built to stop operating at that time, and many users find they get a year or more out of them).
The parent community is delighted by new access to data from both systems, and partners of adults with diabetes find being able to view the blood sugar data of their loved ones in real time a huge stress reliever.
But after years of wanting more connectivity, once it was finally available, adult diabetes patients have had mixed feelings about it. Talking about his research on adult Type 1 patients, William Polonsky, MD, of the Behavioral Diabetes Institute, said, “On the one hand, almost all the adult Type 1s we interviewed felt quite strongly that ‘these are my data and I don’t need anybody seeing my data ever, period.’ After some reflection, however, most people added that, on the other hand… ‘gee, if I was sleeping alone some night or I was having an unexpected spot of trouble, it sure might be nice to know that there is some trusted friend out there who would have my back.’”
The connectivity revolution is showing no signs of slowing down. Also sharing diabetes device data with the Apple iPhone is Medtronic Diabetes’ new MiniMed Connect device, a key fob-sized optional companion to the company’s 530G and Revel insulin pumps that allows both CGM and pump operational data to be viewed pretty much anywhere in the world. It’s a multi-step process: The pump communicates with the Connect, which communicates with an Apple phone, which uploads its data to the web, which any web-enabled device can view. The Connect device also uploads data to the well-regarded CareLink clinical software.
Roche Diabetes Care debuted its AccuChek Connect blood glucose meter in the U.S. It provides wireless transfer of blood glucose readings to a smartphone and up to the web. Unlike most of the current lineup, which initially could communicate only with Apple IOS, the Connect meter could talk to both Apple and Android devices when it was first released. (Dexcom released an Android app for the G5 in late 2015, many months after the device was introduced.) The bigger news about AccuChek Connect, however, is that it’s the first connected app to provide insulin dosing recommendations via a built-in bolus calculator, letting the system function as a semi-automated virtual insulin pump for patients using syringes or pens.
Largely driven by new medications, the disposable pen market has seen the entrance of several new players. Over the last five decades, the majority of insulins in the U.S. have had a concentration of 100 units per milliliter, called U-100. However, the twin epidemics of diabetes and obesity have resulted in very large doses of insulin being needed for some patients, since insulin requirements increase with body mass. Several concentrated insulin formulations designed to address these increased needs were released in the past year.
Driving the headlines was the first-to-market Toujeo from Sanofi, a super-sized Lantus basal insulin, which comes in the newly redesigned Toujeo SoloStar pen. Toujeo is a U-300 insulin, three times stronger than the original Lantus. To avoid confusion, Sanofi designed its new pen to deliver one-third-sized units without changing the calibration numbers of the pen. The idea was that the new pen and insulin could be used with a 1:1 dose conversion. If you needed 65 units of Lantus, you’d just dial up “65” on the new pen and get one-third the volume of a three-times more potent formula.
However, the mixed marketing messages of the insulin being more powerful while needing the same “dose” confused both consumers and clinicians. Further complicating matters was the fact that the medication wasn’t truly three times stronger, requiring an increase after the 1:1 conversion, and while the new pen holds a larger relative load — at 1.5ml of U-300 medicine, it holds 450 units compared to the 300 units of the old 3-ml Lantus SoloStar pen — Sanofi missed an opportunity by leaving the maximum dose the new pen can deliver unchanged. A patient who needed more than one injection of Lantus still required more than one injection of the new U-300 product, making a switch to the higher concentration somewhat pointless.
Novo Nordisk didn’t miss this boat, however, when it released its U-200 version of the Tresiba FlexTouch basal insulin pen at the end of 2015. The new pen allows users to dial up to 160 units in a single injection. Like Toujeo, the unit is standardized for 1:1 conversion. (Note: The Tresiba pen also comes in a U-100 version with a maximum injection size of 80 units.) The new Tresiba pen is part of the FlexTouch family, first released in the U.S. in 2014 with Levemir, and is the only pen that features no push-button extension. Push-button extension becomes a real problem with large doses from most pens, requiring two-handed operation. Showing unusual humor, Novo’s advertisements for the new pens featured the tag line, “Because we can’t re-design thumbs, we designed FlexTouch.”
Adding to the pen pack, Eli Lilly released a new version of its KwikPen with the U-200 rapid-acting insulin Humalog 200. Like the other concentrated insulins, the pen is designed for 1:1 conversion of dosing to avoid confusion. Also from Lilly, the once-weekly GLP-1 medication Trulicity, released in late 2014, started reaching U.S. consumers in 2015. The medicine is packaged in the truly innovative Trulicity Pen that delivers the medication in three simple steps.
Of course, injecting isn’t the only way to get insulin anymore. New to the market is Sanofi/MannKind’s inhaled insulin Afrezza, with its tiny pocket-sized inhaler. The Afrezza inhaler is a triumph of modern miniaturization.
There also are three new insulin pumps, two of which are combo devices (see below). Tandem Diabetes launched the Tandem t:flex, a pump aimed primarily at people with Type 2 who require greater volumes of insulin. The touch-screen t:Flex features a 480-unit capacity, making it the largest volume pump on the market.
Dexcom G4 technology was center stage in 2015 in two new insulin pumps that integrate with the sensor system. J&J Animas started shipping the long-delayed Vibe pump at the end of 2014, but it didn’t reach most consumers until 2015. The Vibe is a standard issue insulin pump with an integrated CGM receiver and monitor driven by a Dexcom G4 sensor and transmitter. Also joining the combo pack in 2015 was the new Tandem t:slim G4 with CGM. Similar to the Vibe, Tandem has added a CGM powered by the Dexcom G4 to its popular modern form-factor color touch-screen pump.
Unlike 2014’s Medtronic MiniMed low-threshold suspend 530G, these two new pumps are not in any way controlled by the CGM system but still provide a new level of connectivity and eliminate the need for a separate CGM receiver.
In a new approach to treating neuropathy pain, NeuroMetrix describes its Quell as a next-generation TENS unit, using electricity to block pain signals between damaged nerves and the brain. The Quell device is built into a lightweight fabric and Velcro belt that wraps around one leg. The system’s electrodes snap directly to the inside of the belt, and the belt provides a pouch for the controller, eliminating the tangle of wires from traditional electrical stimulators. While scrambling the pain signals from neuropathy doesn’t work for everyone, many users are reporting good results. Furthermore, the Quell is unique among electrical stimulators in having an FDA indication for overnight wear. The company also received FDA approval in January for an upgrade due in March 2016. Enhancements include extended battery life, enhanced data tracking for up to three months, and a second, fast pulse stimulation mode.
Timesulin is both the name of the company and of its crowdsource-funded single product: a timing cap for disposable insulin pens. In 2015, Timesulin became widely available in the U.S., thanks to distribution agreements with Kmart and Rite Aid. The device is a replacement cap featuring a timer that starts when the cap is removed for an injection. This allows users to confirm the time of the last injection and can also be used as a crude insulin onboard timer. Since disposable insulin pens vary from manufacturer to manufacturer, Timesulin has a range of caps to fit all the pens on the market.
Dexcom didn’t limit its impact to devices in 2015. It also released a new data analysis software called Clarity that comes in both clinical and consumer versions. The goal of Clarity is to simplify the huge volume of data that comes from having 256 glucose readings every day.
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