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Cgm Smart Insulin Pen System

New Diabetes Tech On The Horizon: What’s Coming By Mid-2017 In The Us?

New Diabetes Tech On The Horizon: What’s Coming By Mid-2017 In The Us?

By Lynn Kennedy, Ava Runge, and Adam Brown What Abbott, Dexcom, LifeScan, Medtronic, Tandem, and others are bringing to make diabetes easier and less burdensome Want more news just like this? We’re living in the most exciting time ever in diabetes technology, and a slew of soon-to-launch products are going to subtract hassle from living with diabetes – fewer injections and fingersticks, less math, less data overload, less pain, and less worry. Equally important, most emerging technology shows excellent potential to improve glucose outcomes that matter, among them hypoglycemia, time-in-range, hyperglycemia, and A1c. Curious what’s coming? Read on for a summary of the insulin delivery and glucose monitoring devices expected to launch in the US by mid-2017 or earlier, based on the most recent company timelines (listed chronologically). This list is not fully comprehensive, but does cover the major device launches expected. A more detailed description of each device follows further below. New Insulin Delivery Devices Tandem’s t:slim X2 Insulin Pump – October-December 2016. The latest Tandem pump will add a new Bluetooth radio and enable software updates to add future Dexcom G5 connectivity and automated insulin delivery algorithms. Medtronic MiniMed Pro Infusion Set with BD FlowSmart technology – around late 2016. The long-awaited infusion set has several key improvements, most notably a new catheter that allows insulin to flow out of two holes (less occlusions). LifeScan’s OneTouch Via – early 2017. The bolus-only, super slim wearable device holds 200 units of insulin and can be worn for three days. Squeezing two buttons (including through clothes) – will discreetly deliver a two-unit bolus. Medtronic’s MiniMed 670G/Enlite 3 Hybrid Closed Loop – by Ap Continue reading >>

The World's First Smart Insulin Pens With Automatic Wireless Data Transfer (868 Mhz Or Bluetooth®)

The World's First Smart Insulin Pens With Automatic Wireless Data Transfer (868 Mhz Or Bluetooth®)

Fully automated data transfer improves diabetes management Potsdam, Germany / B3C newswire / - Emperra GmbH based in Germany is launching the world’s first Bluetooth® insulin pen on the market and therefore expanding its ESYSTA® product system’s function. The new ESYSTA® BT pen is equipped with a Bluetooth® interface and transfers the injected insulin doses directly to the patient’s digital blood glucose diary. The smart insulin pens automatically connected via the 868 MHz interface (similar to the ISM band) are already being successfully used in medicine in combination with a wireless transmission blood glucose meter as an integrated diabetes management system, ESYSTA®. Both the hardware components and software solutions (ESYSTA® portal, ESYSTA® app) have been certified as CE-compliant medical products. Patients and doctors can achieve a new quality of medical care for Type 1 and Type 2 diabetics using the patented ESYSTA® solution. On the basis of the available scientific data and reimbursement by statutory health insurance companies on the complex German healthcare market, Emperra is striving to use this smart insulin pen based ESYSTA® telemonitoring solution with an FDA filing process for the US market. FDA clearance is expected in 2016. “The smart insulin pen and corresponding software appeal to patients and doctors who prefer state-of-the-art technical solutions and who have recognised that the digitalisation of diabetes management is a simple and reliable solution,” summarises Dr. Christian Krey, CEO of Emperra GmbH. With the help of innovative sophisticated software solutions compliant with medical products and the highest integrated data security standards ISO/IEC 27001, several teams of doctors can even solve complex issues with patients who Continue reading >>

Dexcom Plans To Launch G6 Cgm, First Fruits Of Verily Partnership In 2018

Dexcom Plans To Launch G6 Cgm, First Fruits Of Verily Partnership In 2018

After the latest in a series of successful quarters (with $171.2 million in revenue, up 31 percent year over year), DexCom is queuing up some big product launches. On yesterday’s Q4 earnings call, CEO Kevin Sayer provided more detail about the forthcoming G6 continuous glucose monitor as well as the first products to come out of DexCom’s partnership with Verily. “In a year of much confusion and turmoil in the diabetes industry, DexCom grew revenues more than 40 percent, an annual increase of approximately $170 million in worldwide revenue, a number that's, quite frankly, more amazing than the percentage when you compare DexCom to everybody else in our industry,” Sayer said on the call. Good news from the FDA, which approved DexCom CGMs for non-adjunctive use, and CMS, which recently announced it will reimburse some CGMs including DexCom’s, has the company feeling bullish about the future, though Sayer admitted the CMS rule would likely not translate to profits for the company for a little while as the ruling kicks in and they adapt their sales strategy to target the Medicaid population. But the biggest news on the call was updates on DexCom’s product pipeline. The company plans to release an updated version of the G5 transmitter, which is currently under review, later this year. The update will include a new, more reliable touchscreen receiver, a new insertion system and corresponding smaller transmitter, an Android platform, and additional app features including incorporation of insulin data. The company is targeting its next generation transmitter, the G6, for a Q3 2017 FDA submission and a 2018 launch. “As I mentioned earlier, the early data from G6 has been very impressive,” Sayer said. “Assuming this performance is replicated in the pivotal trial, Continue reading >>

The Future For Insulin Pump Companies: Who Will Survive?

The Future For Insulin Pump Companies: Who Will Survive?

www.diabeticinvestor.com As problems for Tandem continue, and with Johnson & Johnson abandoning the insulin pump market, it’s beginning to dawn on some people that we soon could live in a world with just two insulin pump companies – Medtronic and Insulet. [Editor’s Note: Johnson & Johnson reached out to us with the following information: “Animas continues to manufacture, deliver and support its products and provide the service our patients expect. We remain committed to our patients, and we intend to honor our warranty and do not anticipate any interruptions to patients’ pump therapy. If patients or potential patients have any concerns, they can contact Animas online or at 1-877-YES-PUMP.”] Ok, to be fair, Roche also has a pump, but their market presence is lacking. Also, to be fair, Bigfoot is working on a system, but it isn’t here yet. Plus, there is growing belief that patients can achieve optimum control using a CGM smart insulin pen system. Given where things stand today, the real possibility exists that when it comes to insulin pumps, patient choice will be very limited. This was a fear expressed by many when Medtronic signed an exclusive deal with UnitedHealthcare. Yet this agreement is not the cause of limited patient choice. Poor strategy is the real reason, as both Tandem and J&J have made mistakes that have put them in their current positions. Now, I will not list these mistakes as it serves no useful purpose; there is no need to go backward. What I will do, however, is offer a path forward for any company that is bold enough to take on Medtronic. Keep in mind that Diabetic Investor has been covering Medtronic since it was known as MiniMed and no one, and I mean no one, has come close to giving them a run for their money – EVER. The insulin pu Continue reading >>

Dexcom Announces Development Agreement With Lilly To Integrate Dexcom Cgm Into Connected Diabetes Ecosystem

Dexcom Announces Development Agreement With Lilly To Integrate Dexcom Cgm Into Connected Diabetes Ecosystem

DexCom, Inc. (NASDAQ: DXCM), the leader in continuous glucose monitoring (CGM) for people with diabetes, today announced a development agreement with Eli Lilly and Company (NYSE: LLY) to include DexCom CGM into Lilly’s Connected Diabetes Ecosystem. The companies expect to combine Lilly’s smart insulin delivery devices and Dexcom CGM to improve the future of diabetes management. "Lilly’s Connected Diabetes Ecosystem promises to drive a significant step forward in diabetes management. As technology converges in our industry, we believe that connected systems will become the standard of care over time,” said Kevin Sayer, President and CEO of Dexcom. "By combining devices, drugs and technology, we can deliver solutions that adapt to each person’s unique needs in managing their diabetes while also providing compelling advancements for both physicians and payers.” Through the Connected Diabetes Ecosystem, the companies aim to provide a comprehensive solution to people with diabetes. Devices such as CGM, smart-pens and insulin pumps, drugs, apps and other analytical tools will be aimed at improving outcomes. Clinical trials are expected to begin by the end of 2017. "The Connected Diabetes Ecosystem relies not only on Lilly’s core diabetes expertise, but also the strength of our key partners such as Dexcom,” said Enrique Conterno, president, Lilly Diabetes and Lilly USA. "Dexcom will be an important collaborator in our mission to improve outcomes and reduce the daily burden for people with diabetes.” About DexCom, Inc. (NASDAQ: DXCM) DexCom, Inc., headquartered in San Diego, CA, is dedicated to helping people better manage their diabetes by developing and marketing continuous glucose monitoring (CGM) products and tools for adult and pediatric patients. With ex Continue reading >>

Senseonics Leads Development Efforts Of A Long-term “artificial Pancreas” System For Use In The International Diabetes Closed Loop Trial

Senseonics Leads Development Efforts Of A Long-term “artificial Pancreas” System For Use In The International Diabetes Closed Loop Trial

Three European Clinical Trial Sites Tapped to Test Closed Loop System GERMANTOWN, Md.--(BUSINESS WIRE)-- Senseonics Holdings, Inc. (NYSE-MKT: SENS), a medical technology company focused on the development and commercialization of transformative glucose monitoring products, today announced a collaboration with TypeZero Technologies, Inc., a personalized diabetes management company, and Roche Diabetes Care, Inc., a global leader for diabetes management systems and services, to develop a long-term automated insulin delivery system. The collaboration is part of the National Institutes of Health (NIH)-funded International Diabetes Closed Loop (IDCL) Trial, which was designed to test automated insulin delivery systems. “This partnership is an example of how industry, research and clinical care work together to move innovative technologies from research to development and then to patients to minimize the burden of diabetes,” said Boris Kovatchev, PhD, Director of the Center for Diabetes Technology at the University of Virginia and principal investigator of the IDCL Trial. This phase of the IDCL Trial will integrate Senseonics’ Eversense® CGM System, a long-term, implantable continuous glucose monitoring (CGM) system with TypeZero’s inControl AP algorithms and Roche’s Accu-Chek® Insight Insulin Pump. The inControl software will automatically adjust and regulate insulin delivery based on the combination of data received from the CGM system and the insulin pump. “The promise of automated insulin delivery systems is the ability to automatically and sustainably maintain tight glucose control while avoiding hypoglycemia. With this partnership, we are one step closer to bringing this promise to market and to significantly improve the everyday challenges of people with d Continue reading >>

New Smart Tech Improves Diabetes Management

New Smart Tech Improves Diabetes Management

A new frontier of tools for diabetes management is here. Move over, test strips! Step aside, hand-held blood glucose monitors! Make way for a new generation of diabetes management tools that are changing the way patients manage their disease and their lives. Today’s innovative smart technology ranges from insulin pumps and memory chip-equipped insulin pens to sensors applied directly to skin for continuous glucose monitoring (CGM) and other wearables. All this and more is currently in development and coming to market at an impressive rate. CNBC reported earlier this year that a team of biomedical engineers at Apple is involved in an initiative to develop noninvasive sensor technology to continuously monitor blood sugar levels. Verily has at least two glucose sensing/monitoring projects in the works, including a glucose-sensing contact lens. Both companies are participating in the FDA’s precertification pilot program, part of its initiative to foster digital health innovation. Independent pharmacist Jonathan Marquess, PharmD, CDE, a Past President of the Georgia Pharmacy Association, is enthusiastic about new technology that makes it easier to individualize treatment plans for his patients. He is particularly excited about alternatives to the traditional finger stick, which provides information at just one point in time, and not a more useful glucose profile. Marquess also likes the versatility of the newer insulin pumps. “It is exciting to know that we have new pumps that we can set for various basal rates,” he says. “There are many small, discrete pumps now that let patients enter the amount of carbohydrates that they ingest and the pump will calculate how much insulin to secrete.” Another smart tech option that will soon be available is Abbott Labs’ Free Continue reading >>

Companion Medical Wins Fda Nod For Inpen Insulin Pen

Companion Medical Wins Fda Nod For Inpen Insulin Pen

Companion Medical won FDA 510(k) approval for its wireless-enabled InPen insulin pen and mobile application. InPen is a new injector pen that actually contains computer chip technology built right into the base, including Bluetooth LE wireless capability. This is a huge step beyond the existing insulin pens on today’s market. The InPen will provide smart technology: • Collection of user’s data with transmission to an app that contains a dose calculator and calculates insulin on board (IOB). • The App will allow users to set up reminders for specific times for each meal and snack, and if there is no dose by the end of that time period, the app will alert the user. • Remote monitoring for caregivers – users can set the app to auto text message their dosing info to a designated number of people. This can include insulin dose as well as BG and carb values (if entered manually) –all noted in a single text message. • Temperature sensor – this is built into the pen and will set off an app alarm if the pen’s temp drops below freezing or above body temperature, to ensure your insulin stays intact. “FDA clearance of the InPen and mobile app represents a significant advancement in diabetes care. The product combines the benefits of sophisticated insulin pumps with the simplicity and affordability of pens and syringes, providing patients, physicians, and caregivers increased confidence that diabetes is being managed optimally. We are excited to be the 1st to introduce this entirely new class of insulin delivery,” CEO Sean Saint said in a press release. “Diabetes is a complex and burdensome condition requiring accurate insulin doses to stabilize blood sugar levels and prevent long-term complications. Smart pens offer an improved dosing option for people liv Continue reading >>

Lilly Developing Smart Pens And Automated Insulin Delivery With A Pump

Lilly Developing Smart Pens And Automated Insulin Delivery With A Pump

By Jeemin Kwon, Brian Levine, and Adam Brown First trial next month, launch expected in 2-3 years; Dexcom CGM included; a big commitment to diabetes tech innovation from an insulin company During a time of fast-paced innovation and competition in the world of diabetes, Lilly has joined the race to offer tech-enabled, smarter methods of insulin delivery to people with diabetes. In two to three years, Lilly, a major insulin player, plans to launch two systems: Automated insulin delivery (AID) with Lilly’s own custom disk-shaped pump, CGM, and a hybrid closed loop control algorithm; and Smart insulin pens with a dosing decision (“titration”) support app. Lilly has been developing both products for two years, and the first trials are expected to begin next month. Dexcom’s CGM will be used in both, per an agreement announced in tandem with this news. All three major insulin companies – Lilly, Novo Nordisk, and Sanofi – are investing in digital health and connected delivery devices, though this represents the largest commitment yet. Lilly will bring all the components together for smarter insulin delivery (both pump and injection), submit them to the FDA, and commercialize both systems. Bigfoot Biomedical is currently the only other company pursuing both injection- and pump-based automated delivery of insulin. Read below for more details! Lilly’s AID System – A New Disk-Shaped Pump Lilly’s AID system will use its own custom pump designed by Dean Kamen and the team at Deka Research and Development Corp (inventors of the Segway). The tubed pump is “a white disk about the size of a shoe-polish tin” and holds three days of insulin. It has an infusion set with tubing, but in a new approach, is small enough to be worn directly on the body (like a patch pump) o Continue reading >>

Insulin Smart Pens

Insulin Smart Pens

Insulin smart pens offer an easy to carry solution to diabetes management. Any insulin dependent diabetic is familiar with the idea of insulin pens. There are a couple advantages to using an insulin pen as opposed to a bottle and syringe. The pen is more convenient when you are on the go or traveling. Insulin pens make it easy to deliver consistent and accurate insulin doses. For those of you that aren’t familiar with insulin pens, there are two basic types, disposable and non-disposable insulin pens. Non-disposable pens you load yourself with insulin cartridges. You can buy the insulin cartridges in packs of five. The pen itself should last you a couple years before you need a new one. Disposable pens come filled with insulin and then are thrown out when empty. Most pens are filled with 300 units of insulin. While these pens tend to be more convenient, they are also more expensive than reusable pens. Smart Insulin Pens Companion Medical has began to test their new “smart insulin pen”. The Companion Medical pen isn’t the first pen of its kind, but it’s the most impressive. The Memoir Pen from Eli Lilly and Echo Pen from Novo Nordisk are both already available in the UK, but don’t offer as many features as the Companion’s pen will. Both competitor pens can track the time and dosage amount, but that’s where the similarities end. Companion Medical Smart Pen Companion Medical is changing the way that people with diabetes look at insulin pens. Companion is combining the technology of a smart phone with the simplicity of an insulin pen. The “InPen” will offer several interesting features. The “smart pen” can track dosages and the times that they were delivered just like previous smart insulin pens. The user will be able to look back through the days to Continue reading >>

New Diabetes Products For 2017: Insulin Delivery Devices

New Diabetes Products For 2017: Insulin Delivery Devices

For the last year, Diabetes Self-Management has been following all the new innovations and products aimed at helping to improve the lives of those living with diabetes. From the latest glucometers and monitoring systems to insulin pumps, pens, and treatments, several major advancements made their impact on the diabetes community in 2016. When selecting some of the new products, we first talked to Gary Scheiner, MS, CDE, clinical director of Integrated Diabetes Services of Wynnewood, Pennsylvania. Scheiner, known as the MacGyver of diabetes products, has lived with Type 1 diabetes for more than 30 years. He tries out new products before recommending them to patients. “It’s important to see new products from the user’s point of view, not just from the [health-care practitioner’s] side of things,” said Scheiner. In 2016, the pace of innovation continued to race ahead with unbelievable technology right out of a Star Trek episode. The growing use of smartphone technology and mobile applications has led to better access to blood glucose readings, general health information, and much more. Read on to learn about the newest products. We guarantee you there’s something here for everyone, whether you live with Type 1 or Type 2 diabetes. In this installment, we look at insulin delivery devices that have recently hit the market. Insulin pumps, pens, and patches Joining its family of insulin pumps, Tandem Diabetes Care introduced the t:slim X2 Insulin Pump — similar to the t:slim — late last year. The new pump features an advanced two-way Bluetooth radio and uses technology to update software remotely, much like a mobile phone. The pump is compatible with the Tandem Device Updater, a new tool that allows users to update the software from a personal computer. The pump Continue reading >>

Companion Medical Announces Us Commercial Launch Of Smart Insulin Pen System

Companion Medical Announces Us Commercial Launch Of Smart Insulin Pen System

Register to receive a free US Market Report Suite for Diabetes Monitoring, Treatment and Drug Delivery report synopsis and brochure Companion Medical, a leader in the development of advanced technology to improve diabetes care, recently announced that it has begun commercial sales of the InPen® system in the United States. InPen is available by prescription only and is a covered benefit under many insurance plans. The InPen is for use with U-100 Lilly Humalog® and Novo Nordisk Novolog® rapid-acting insulin and indicated for persons aged 12 years and older. The Companion App home screen gives a summary of your current data. It provides last dose and last blood glucose information, an active insulin display (like an insulin pump) and a graphical depiction of the last 10 hours. In addition, you can access the dose calculator to help with the diffcult calculations required for insulin dosing. “I am pleased to announce the commercial launch of InPen. The InPen system is a significant step toward true integrated diabetes management,” said CEO Sean Saint. “Our team has worked diligently to develop a solution for people living with diabetes who want the benefits of an insulin pump without the cost or burden of being tethered to a device.” The Companion App home screen gives a summary of your current data. It provides last dose and last blood glucose information, an active insulin display (like an insulin pump) and a graphical depiction of the last 10 hours. In addition, you can access the dose calculator to help with the diffcult calculations required for insulin dosing. InPen is the first and only FDA-cleared solution that combines an insulin injector pen with an intuitive smartphone app and bolus advisor using Bluetooth® technology. InPen tracks insulin doses, inc Continue reading >>

The Future For Insulin Pumps

The Future For Insulin Pumps

Guest Post by David Kliff, Diabetic Investor Newsletter. This morning I learned of yet another closed-loop insulin delivery system, i.e. artificial pancreas, under development. Per a post on the Drug Delivery web site: Cellnovo and Diabeloop said this week they are launching a CE Mark cross-over registration study for an artificial pancreas device Diabeloop is developing which uses Cellnovo’s insulin pump. Now keep in mind that Medtronic is currently launching the 670G, the artificial pancreas that really isn’t an artificial pancreas. Animas, Insulet, and Tandem all have closed-loop projects under way and the premise behind Bigfoot is a closed-loop system. Is it possible that this way-cool whiz-bang device could end up like every other whiz-bang way-cool diabetes device and become a commodity? Yep! Is it possible that when it becomes a commodity there will be a price war? Yep! Do we really need 5 or 6 of these suckers? Nope. Will that stop anyone from trying? Nope. The reality is we are still trying to figure out how anyone is going to make money in this market. Just looking at the 670G from Medtronic and all the additional expense this system demands, it does make one wonder. So far patient reaction to the 670G has been what I have anticipated, a love-hate affair. When it works, patients love it; when it doesn’t, it’s just another pump. Also, as I anticipated, the pump itself is nothing special and the love-hate scenario rests solely on sensor performance. Based on everything I have seen and read so far, the new Enlite sensor is better than the old one. That was a low bar to jump over. Is it as accurate and reliable as the Dexcom G5? That’s debatable. Yet, let’s look beyond which sensor is “better” or which pump has a more patient-friendly user interfac Continue reading >>

After 20 Years Of Watching Diabetes Tech, Kliff Eyes Smart Insulin Pens, Cgm For Patients With Type 2 Diabetes

After 20 Years Of Watching Diabetes Tech, Kliff Eyes Smart Insulin Pens, Cgm For Patients With Type 2 Diabetes

An experienced market watcher who has diabetes predicts the key to success will come down to one factor: ease of use. Although current medications can maintain healthy blood sugar levels in most patients who have type 1 (T1D) or type 2 diabetes (T2D), most patients don’t use them correctly and therefore suffer the expensive and unpleasant complications of both hyper- and hypoglycemia. Less than half of all patients with T2D achieve glycemic goals advocated by the American Diabetes Association, and about two-thirds die prematurely of heart disease.1 Study results indicate that educational interventions can boost treatment adherence, at least among some patients,2 but many experts believe the only hope for widespread improvement among real-world patients lies in new medications and novel technologies—products that dramatically reduce the pain and complexity of proper self-care. David Kliff, who has run Diabetes Investor since he was diagnosed with the condition more than 20 years ago, is a leading spokesman for this view. His livelihood depends upon being able to predict how patients will behave (and, therefore, what they will buy), and he scoffs at the notion that any affordable intervention produces significantly better outcomes with traditional treatment tools. He believes that better tools can produce better outcomes, that several significantly better tools have recently hit the market, and that more are coming soon. Kliff is not alone in his general optimism, but his specific predications differ from those of many others who think technology is about to revolutionize diabetes care. For example, Kliff said he doubts that any of the “artificial pancreas” devices currently under development will have any major impact on patients with T1D in the next decade. He t Continue reading >>

Companion's New Smart Insulin Pen Will Mimic A Pump

Companion's New Smart Insulin Pen Will Mimic A Pump

What if an insulin pen could help you calculate needed doses, and then track all of your doses and times, plus IOB (insulin on board), and even send you alerts and reminders about missed doses and more? Well, it would be a pen unlike any other, in many ways mimicking the functions of an insulin pump. This is exactly what's under development by San Diego-based Companion Medical, which scored a $3 million investment from Eli Lilly in May, on top of previous financing from Diamyd Medical. Code named InPen, this new injector pen actually contains computer chip technology built right into the base, including Bluetooth LE wireless capability. This is a huge step beyond the two existing first-generation "smart" insulin pens -- Lilly's own Memoir pen and the newer Echo pen from Novo Nordisk -- that only track a handful of previous doses and can't transmit that data anywhere. Also, neither of those can do math or suggest dosing. The InPen, by contrast, offers truly smart technology: it collects users data and transmits it to an app that contains a dose calculator, and also calculates real-time insulin on board (IOB). like a pump, the companion app also allows you to set up reminders for specific times like breakfast, lunch, dinner, and bedtime snack, and if you haven’t dosed by the end of that time window, the app will alarm. there's a temperature sensor built into the pen that sets off an app alarm if the pen's temp dips below freezing or above body temperature, ensuring that your insulin is intact. it allows remote monitoring – users can set the app to automatically text message their dosing info to up to 5 people. This can include not only every insulin dose, but also BG and carb values (if entered manually) -- all compiled into a single text message. "Why are we doing th Continue reading >>

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