As of 2016, an estimated 500,000 people1 in the US were using insulin pumps and this number is growing. Many patients tell me they feel confused by all the options but for the best user experience, it's crucial that the person wearing the pump be part of the decision about which style and type of pump will work best for them.
Before I get to all the options, let's take a stroll down memory lane. Progress was slow at first but the last 5 years has been one big wow after another!
The companies that are racing toward the finish line of developing an artificial pancreas, otherwise known as a fully automated pump, seem to increase exponentially.Here's a look a what's to come in the land of pumps.
Closed Loop Tech
Some refer to this technology as the “Artificial Pancreas System.” Regardless of the name you use, it's about "closing the loop" in glucose monitoring and insulin dosing. While fully closed loops that will require no user intervention will not be available for use by the public in the year to come, there are some hopeful signs of progress from several companies.
This Boston-based startup has created its fourth-generation prototype of the iLet4 system, a dual-hormone glucagon, and insulin closed-loop device.
While it's not likely any products will be brought to market this year, Bigfoot plans to submit an investigatory study request with regulators and start its pivotal trial for the "Bigfoot Loop," an infusion-pump based automated insulin delivery (AID) system.
This patch-style pump has been available outside of the US for a few years. The company has been awaiting FDA approval for over a year—submitted an application to the FDA in November 2016. This patch pump is different than Omnipod in that it has a very short infusion set, allowing the user to disconnect. Cellnovo has also partnered with closed loop startup TypeZero Technologies as well as Diabeloop so this product may be seen in a variety of projects.
Next-Generation 690G and Harmony 1 CGM Sensor: This pump will be an upgrade to the current 670G with a clear focus on the accuracy of the sensor. Conceptual research on this redesigned CGM sensor showed a 10-day wear time with single calibration, using a proprietary "fusion" algorithm allowing for better accuracy. It also was said to have improved adhesive-backing to keep the sensor on more securely and built-in Bluetooth Low Energy for smartphone communication. Since clinical trials on this product are underway, more news may come by the end of the year, but the launch is currently undecided.
OmniPod's Next-Generation Platform
DASH PDM: The new OmniPod DASH system was filed with the FDA at the start of 2018, leading to a possible launch by end of the year. The tubeless Pod will retain the same size and shape but will have Bluetooth low-energy wireless capability built in to allow for communication with the new color touchscreen PDM (controller unit).
This will also allow for communication with any Bluetooth-enabled fingerstick glucose meter, but that means the DASH will not have a built-in FreeStyle glucose meter like the current system. The DASH will ship packaged with a Contour meter from Ascensia Diabetes.
Insulet's (makers of OmniPod) Bluetooth-enabled Pod and PDM will be able to talk directly with a smartphone app that will allow the user to track features like Insulin on Board (IOB), dosing records, BGs, and CGM data both on the new PDM and on their smartphone screens. The new PDM will also contain an improved food database for carbohydrate information.
Future Products from Omnipod: When the DASH launches, it will be limited to certain locations. This Bluetooth-enabled DASH will also serve as the platform for new generations of OmniPod products, including the higher-concentration insulin pods being developed with Eli Lilly. Estimated timelines for these products are late 2019-2020 for pods that can use u-500 insulin and u-200 insulin.
Horizon Closed Loop: While the company’s goal is to have this on the market by 2020, Insulet's OmniPod Horizon system would be an addition to the Artificial Pancreas race but in a tubeless patch pump.
Tandem Diabetes Care
Tandem is the only company to tout that it has brought a new product to market every year since they started—and I don't see them stopping anytime soon!
"Basal IQ" Predictive Low Glucose Suspend (PLGS) System: This device would be their first-generation automated insulin delivery system, designed to automatically decrease or suspend insulin when blood sugars are predicted 30 minutes prior to or below 80 mg/dL based on the Dexcom G5 CGM sensor values. This will be unlike current suspend features (that turn off for 2 hours), where it will be suspended for a minimum of 5 minutes to up to 2 hours.
Hybrid Closed Loop: The second-generation system is a hybrid that would function similarly to the Minimed 670G, except Tandem’s pump would use Dexcom CGM and the TypeZero algorithms. Tandem just completed its first pivotal trial and expects to do more later in the year, with a possible launch in the first half of 2019.
The big question is, who is the right person for a pump? Here are a few thoughts on this important questions:
While there are definitely specific characteristics of people who will do better on an insulin pump, I still believe that choosing to wear a pump is a personal decision and has to be made by the individual who will be wearing it—armed of course with as much information as possible.
I have conversations with patients all the time. Here are the main discussion points:
For those folks who are perfectly content on multiple-daily injections, are “rocking their diabetes” so to speak, want nothing to do with wearing a device, and feel it may affect their quality of life, to them, I say, "Sit this one out".
For others who are interested in trying another way of insulin delivery, there are no easy answers. Each person is unique and it is important to work with a health care provider willing to review all the options. One thing is for certain, wearing a pump is a personal choice and it is one very good option in many for diabetes self-management.