Diabetes Tech on the Horizon – New Insulin Delivery Systems Coming in 2018
This article is reprinted with permission from diaTribe. Find the unique article right here.
By Maeve Serino and Adam Brown
Learn about what’s new and what’s coming quickly in Smart Pens, automated insulin supply, pumps, and extra
Diabetes know-how strikes quick, so that will help you hold observe, we’ve rounded up a few of the newest choices – and choices coming quickly – for insulin supply. (You can learn diaTribe’s updates about the newest diabetes apps and software program right here, and CGM right here.) Below, you’ll discover merchandise which have not too long ago turn out to be out there or are anticipated to launch in the subsequent yr or so based mostly on the most up-to-date timing updates we’ve heard. This article shouldn’t be fully complete – and timelines usually change – however this listing covers lots of the most notable merchandise in insulin supply, together with sensible pens, automated insulin supply, improved pump applied sciences, and extra. A extra detailed description of every product follows the desk of contents beneath.
Click to leap to a product, that are organized chronologically by their anticipated launch date inside every class:
New Insulin Delivery Devices
Companion Medical InPen (sensible pen + smartphone app)
Now out there in the US
What’s New? Companion Medical’s Bluetooth-enabled, reusable InPen (sensible insulin pen and paired app) launched this month in the US, following FDA clearance in August 2016. Many insurance policy are overlaying InPen, with pharmacy copays usually coming in at $zero and $50, with some at $120. The reusable pen lasts a yr, requires a prescription, and can be out there to order from mail order pharmacy and choose pharmacies, and maybe finally from Companion Medical’s web site. The full money worth – for these with out insurance coverage protection – is a steeper $549.
As beforehand reported, the system is cleared to be used with Novolog and Humalog cartridges, that are inserted into the pen (and are acquired individually). InPen routinely tracks insulin doses and sends the knowledge to a paired smartphone app – initially for iPhone however finally coming to Android. The app additionally features a mealtime bolus calculator, automated insulin-on-board monitoring, dose historical past, and insulin temperature. Companion will ship customers a free AgaMatrix Bluetooth-enabled blood glucose meter with the pen.
Medtronic MiniMed 670G hybrid closed loop + Guardian Sensor three
Currently out there in the US (over 20,000 customers), although a sensor scarcity has slowed new shipments and received’t be resolved till Spring 2018.
An worldwide 670G launch is anticipated by April 2018; international locations haven’t been specified.
What’s new? While 670G precedence entry program pump shipments had been accomplished as of November 2017, a present CGM sensor scarcity shouldn’t be anticipated to be resolved till February-April 2018. This means for brand spanking new 670G orders, sensor and transmitter shipments can be delayed till the new yr. Over 20,000 persons are utilizing the MiniMed 670G, and in about 13,000 individuals importing knowledge into CareLink, outcomes are much like the pivotal trial (e.g., sturdy reductions in hypoglycemia, extra time-in-range).
The MiniMed 670G is anticipated to launch outdoors the US by spring 2018, a notable delay from the earlier plan to launch this yr. It’s unclear which international locations have acquired regulatory approval right now. The restricted sensor provide (see above) has seemingly restricted the worldwide launch.
Tandem t:slim X2 Insulin Pump with Predictive Low Glucose Suspend (PLGS) and Dexcom G5 CGM
Expected US launch in Summer 2018
What’s new? The t:slim X2 insulin pump has a two-way Bluetooth radio and is able to on-line software program updates like the one which allowed customers so as to add Dexcom G5 integration in late August. Tandem is at the moment working on a Predictive Low Glucose Suspend (PLGS) characteristic, anticipated to launch in summer time 2018. PLGS quickly suspends basal insulin supply when the consumer’s blood glucose stage is predicted to be low after which routinely resumes insulin supply when glucose ranges begin to rise. The system’s pivotal trial started enrolling in August and is anticipated to finish by the finish of 2017. As with the Dexcom G5 integration, the PLGS improve can be out there to current t:slim X2 clients through a free distant software program replace – a significant win for present pumpers, who usually fear about paying 1000’s of to maintain up with the newest know-how.
Insulet Omnipod Dash private diabetes supervisor (PDM)
Limited market launch in the US in mid-2018
What’s new? Insulet’s tubeless, on-body pod will quickly join through Bluetooth to an up to date touchscreen handheld, Omnipod Dash. Dash is definitely a “locked down” Android smartphone, which means it has the consumer expertise of a consumer-grade product, however with out the mobile capabilities, different apps, or an built-in blood glucose meter. It will talk wirelessly with the pod to regulate insulin supply and can discuss to a separate Bluetooth-enabled Ascensia Contour glucose meter. For dad and mom, Dash will add distant monitoring capabilities – the handheld will relay knowledge to a close-by cellphone, enabling caregivers to remotely (or domestically) “follow” pump knowledge (much like following CGM knowledge). Omnipod Dash is anticipated to be submitted to the FDA close to the finish of 2017, with a restricted US launch anticipated in mid-2018. Over time, we consider all Omnipod pumpers will transfer to the new Dash system, as Insulet is altering the pod’s communication to Bluetooth. The Omnipod Dash platform may even be the foundation for extra merchandise, together with a hybrid closed loop system with Dexcom’s G6 (Omnipod Horizon) and compatibility with U200 and U500 insulins. For extra on Omnipod Dash, learn right here.
Medtronic MiniMed Pro-Set with BD CirculationSmart know-how
US launch anticipated to renew by September 2018
What’s New? Medtronic’s new infusion set boasts BD’s CirculationSmart know-how, which facilitates insulin circulation by:
- Adding a brand new facet opening to the catheter
- The smallest insertion needle amongst Medtronic units
- A auto-deployed sliding protect that helps stop unintended needlesticks
- A multi-position connector permitting for eight completely different configurations of the connection between the tubing and the on-body set.
The set launched in September 2016, however as a consequence of a higher-than-anticipated fee of complaints related to kinked cannulas and elevated blood glucose ranges, Medtronic determined to pause shipments. A follow-up examine hoping to resolve these points was not too long ago carried out – a promising signal that this challenge is transferring ahead and that the launch will resume on schedule. See our earlier check drive from the restricted launch. Adam did expertise a few of these kinking points (a coaching drawback), however he actually appreciated the set’s design and options.
BD Type 2 Basal-Bolus Patch Pump
Possible launch in October 2018-September 2019
What’s New? The launch for this disposable, basal-bolus patch pump for kind 2 diabetes is anticipated in October 2018-September 2019, a wider timing window than the earlier hope to launch in the second half of 2018. BD has determined to conduct a further scientific trial for the patch pump, contributing to the delay. As of the final replace, we all know that the pump holds 300 models of insulin in a disposable, three-day-wear, on-body wearable. It will talk with a reusable handheld (much like the Omnipod), and can be designed for basal-bolus insulin customers with kind 2 diabetes. The controller additionally has Bluetooth and might additional ship knowledge to a smartphone. Affordability is a significant objective, and BD goals for the value to be on par with basal-bolus injection remedy.
BD Smart Insulin Pen Needles
Possible launch in October 2018-September 2019
What’s New? BD’s sensible pen attachment is anticipated to suit over the finish of insulin or GLP-1 disposable pens, wirelessly transmitting dose knowledge to a paired smartphone app. This know-how might help individuals with diabetes on insulin higher handle their doses and hold their suppliers knowledgeable. Eventually, there could possibly be integration with CGM or sensible algorithms so as to add dosing recommendation. Like the patch pump, the launch was additionally not too long ago delayed to October 2018-September 2019 (again from the earlier “second half of 2018” plan).
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