Insulet Artificial Pancreas

Insulet’s Omnipod Dash System To Add Touchscreen And Bluetooth

By Ava Runge and Adam Brown Expected in 2017. Plus, the latest in the pipeline, including concentrated insulin systems and the Horizon Automated Glucose Control System During its first-ever Investor Day, Insulet shared timing and new details on its key products in development. The highlights: “Omnipod Dash” is expected to launch by the end of 2017 and will integrate Bluetooth into the body-worn, tubeless pod, and use a transformed, locked down Android smartphone for functions currently performed on the personal diabetes manager (PDM) handheld device. An Omnipod System designed to be used with concentrated Lilly U500 and U200 insulin (for those with higher insulin requirements) is expected to launch in the first half of 2019 and late 2019-early 2020, respectively. The Omnipod Horizon Automated Glucose Control System (to automate insulin delivery with Dexcom CGM) is slated for a “late 2019” launch. Read on below for details on each product. Omnipod Dash System – Launch expected by the end of 2017 Insulet’s next big update, called Omnipod Dash, will add Bluetooth into the pod and finally bring a refresh to the personal diabetes manager (PDM) handheld device. A touchscreen Android phone will now become the Omnipod PDM, a big step up over the current handheld that looks very much like a medical device. The Android phone PDM will be “locked down,” meaning it will not have cellular capabilities, other apps, or an integrated blood glucose meter. It will use Bluetooth to communicate wirelessly with the pod (e.g., to deliver a bolus) and to talk to a Bluetooth-enabled glucose meter (brand not named). The Dash Android PDM will also communicate with a paired app on a user’s normal smartphone that will then relay pump data to caregivers (“followers”; see image Continue reading >>

Quest For The Artificial Pancreas

It is the closest thing to an artificial pancreas the diabetes community has ever seen and the first automated insulin system to be approved by the FDA: the Medtronic MiniMed 670G hybrid closed-loop system. Capable of automatically detecting and preventing dangerous high and low glucose levels, Medtronic’s new insulin system is being hailed as a monumental breakthrough for people with type 1 diabetes. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in an agency news release. Medtronic’s MiniMed 670G uses a continuous glucose monitor (CGM) to track blood glucose levels and an insulin pump to administer insulin. While both of these devices have been around for years, it has traditionally fallen on the user to calculate how much insulin to dose based on blood glucose readings from the CGM. The Medtronic MiniMed 670G introduces a new component to diabetes management that the FDA has long been cautious about: allowing computer software to handle insulin delivery. Too much or too little insulin can have serious and potentially fatal consequences. Users are still required to enter mealtime carbs and periodically calibrate the device, says Medtronic, but this is the first FDA approved device to automatically adjust delivery of basal insulin based on CGM sensor glucose values. How the MiniMed 670G gained FDA approval Proven failsafe mechanisms and encouraging results from a three-month, 123-person pivotal trial gave the FDA the confidence it needed approve the Medtronic MiniMed 670G. Specific findings from the trial pu Continue reading >>

The First ‘artificial Pancreas’ Systems Are Coming To Market

The first so-called artificial pancreas systems – wearable devices that take charge of the crucial process of measuring glucose levels and delivering precise doses of insulin – are now beginning to come to market. That’s welcome news for the nation’s 30 million diabetics, who stand not only to get some relief from the seemingly incessant stream of lancets, test strips and syringes, but also to stay healthier. That’s because an artificial pancreas can keep the disease on a tighter leash than they can, by testing more frequently and delivering more precise insulin doses. That’s not only important for patients, but could ease strains on the nation's healthcare system. This spring, Medtronic became the first supplier out of the gate when it began outfitting a pre-selected pool of type 1 diabetes patients with its new MiniMed 670G. Once that group is trained and equipped – probably by midyear – Medtronic expects to make the device more widely available. Several efforts – including startup Bigfoot Biomedical, Insulet and a partnership between Dexcom, Tandem and TypeZero – are hot on Medtronic’s heels, with active studies now underway and plans to go to market late this year or in 2018. Though the term artificial pancreas is widely used, medical professionals tend to steer clear because some patients hear it and think they’re in for an organ transplant. They’re not. An artificial pancreas doesn’t replace the actual organ. Devices aren’t implanted or surgically attached. Moreover, they only take over one of the organ’s digestive responsibilities: that is, regulating glucose levels. Those in healthcare prefer the term “closed-loop systems,” so called because they monitor glucose levels, employ artificial intelligence to make dosing decisions a Continue reading >>

Omnipod Horizon Hybrid Closed-loop System

Omnipod Horizon Hybrid Closed-loop System Editors update: February 14, 2018, an additional study on the Omnipod Horizon was presented at the ATTD Congress, showing that its algorithm performed well in response to meal challenges and exercise in 24 adults with Type 1 diabetes. Results also showed strong blood glucose control with time in target range (70-180 mg/dL or 3.9-10.0 mmol/L) of approximately 75% and 85% with real-life challenges including high-fat meals and moderate intensity exercise. Additional longer-term studies are currently happening to evaluate the Omnipod Horizon algorithm under free-living conditions in patients of all ages with Type 1 diabetes. Also, starting July 1, 2018, Insulet will distribute its Omnipod Insulin Management System in Europe. Insulet Corporation the company that brought us the tubeless insulin pump, the OmniPod, released some exciting news a couple weeks agowhich could drastically shift the future of Type 1 diabetes management as we know it. From the 10th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Paris, France, Insulet shared the results of their recent feasibility study. This study was the first human study to test the effectiveness of the Omnipod Horizon hybrid closed loop system. This new system contains an automated glucose control algorithm, and results showed that patients experienced excellent glucose control during the day with minimal hypoglycemia overnight and good fasting levels. Over the course of 36 hours, 24 adult patients with Type 1 diabetes tested the Omnipod Horizon system, which utilizes the new predictive algorithm feature, a slightly tailored version of the current Omnipod as well as a Dexcom sensor. Dr. Trang Ly, Insulets VP of Medical who ran the trial took a moment Continue reading >>

Insulet To Begin Patient Trials Of Their Artificial Pancreas System

Insulet to Begin Patient Trials of Their Artificial Pancreas System Earlier this month, Insulet announced that they had their first patient to complete the initial step of their Omnipod Horizon System. The next step will be a clinical trial involving 20 people living with Type 1 diabetes in a clinical setting using the Model Predictive Control algorithm they acquired from Mode ACG out of California earlier this year. The system will be a combined device of the well-known Omnipod insulin management system including a pod and controller, and Dexcoms G4 technology (although its expected to be integrated with their G5 or G6 system upon launch). The artificial pancreas algorithm will help to control the users glucose levels by looking ahead to whats on the horizon for the user, and adjust insulin delivery accordingly. As far as form-factor,the system will maintain its current patch-pump tubeless design, allowing for continued discreetness and uninterrupted insulin delivery during the users three-day use. For more information on the announcement, please visit Insulets Investor Relations announcement , as well as other coverage from diaTribeand MedCity News . Continue reading >>

Insulet Announces Development Partner For The Omnipod Artificial Pancreas

Insulet Announces Development Partner for the OmniPod Artificial Pancreas Insulet Announces Development Partner for the OmniPod Artificial Pancreas : PODD), the leader in tubeless insulin pump technology with its OmniPod Insulin Management System (OmniPod System), today announced a license agreement and partnership with Mode AGC ( ), to develop and incorporate the advanced artificial pancreas algorithm created by renowned researchers MD. This alliance marks a significant step forward in mission to improve the quality of life for individuals with insulin-dependent diabetes. artificial pancreas system will use the innovative and differentiated OmniPod platform, the latest DexCom Continuous Glucose Monitoring (CGM) technology and the algorithm licensed from Mode AGC. The algorithm was created by Drs. Doyle, Dassau and Zisser during their tenure at the -based early-stage medical device company founded by prominent diabetes technology specialist PhD and diabetesadvocate and entrepreneur has worked with Mode AGC and the inventors to optimize the performance of the algorithm for incorporation into a commercial product. Coupled with the unique tubeless OmniPod platform, this system will be poised to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes. continues to make substantial progress toward incorporating advanced artificial pancreas functionality into the future-generation of OmniPod," said Juvenile Diabetes Research Foundation (JDRF) Artificial Pancreas Project "I have had the privilege of working closely with is unquestionably one of the leading Artificial Pancreas algorithm groups in the world. I look forward to continued collaboration with Frank and Mode AGC on developing Continue reading >>

Insulet Unveils Pediatric Artificial Pancreas Data

Insulet unveils pediatric artificial pancreas data Insulet's "artificial pancreas" is based on its OmniPod system, which delivers insulin from a "pod" worn on the body rather than through a catheter. (Insulet) Insulet presented new data from the feasibility study of its hybrid closed-loop glucose control system, showing the device performed as well in children and adolescents as it does in adults. The OmniPod Horizon Automated Glucose Control System is based on the companys OmniPod Insulin Management System, which delivers insulin from a pod, rather than through a catheter. A patient fills the pod with insulin, sticks it to his or her body and uses a handheld device to request bolus insulin when required. The Horizon system goes a step further: It uses an algorithm to continuously calculate and deliver the appropriate dose of insulin. The setup Insulet is testing includes a modified version of its OmniPod system, its personalized model predictive control algorithm and a Dexcom continuous glucose sensor. Like this story? Subscribe to FierceBiotech! Biopharma is a fast-growing world where big ideas come along daily. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go. Continue reading >>

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The Open Artificial Pancreas System project (#OpenAPS) is an open and transparent effort to make safe and effective basic Artificial Pancreas System (APS) technology widely available to more quickly improve and save as many lives as possible and reduce the burden of Type 1 diabetes. OpenAPS means basic overnight closed loop APS technology is more widely available to anyone with compatible medical devices who is willing to build their own system. We believe that we can make safe and effective APS technology available more quickly, to more people, rather than just waiting for current APS efforts to complete clinical trials and be FDA-approved and commercialized through traditional processes. And in the process, we believe we can engage the untapped potential of dozens or possibly hundreds of patient innovators and independent researchers and also make APS technology available to hundreds or thousands of people willing to participate as subjects in clinical trials. The body of work by the OpenAPS community includes a safety-focused reference design, a toolset, and an open source reference implementation that can be used by any individual – or any medical device manufacturer. We believe this will in turn allow manufacturers (and the academic research teams they work with) to turn more of their attention to designing and testing more advanced APS systems, and thereby accelerate the pace of innovation toward new and improved Type 1 diabetes treatments, and eventually a cure. Please note that OpenAPS community efforts will be open source and free for use for other people, open source projects, researchers, and non-profits to use, and available on an open and non-discriminatory basis for all commercial manufacturers to use in proprietary products if desired. Continue reading >>

Diabetes Societies Aim To Gain Medicare Coverage For Cgms, Omnipod

Diabetes Societies Aim to Gain Medicare Coverage for CGMs, OmniPod Ongoing efforts from several fronts are aimed at convincing the US Centers for Medicare and Medicaid Services (CMS) to change its coverage plans for Medicare, which currently exclude several diabetes technologies that don't fit the agency's narrowly defined categories for reimbursement. Although most private insurers now cover personal-use continuous glucose monitors (CGMs) and the insulin-delivery device OmniPod (Insulet Corporation) for patients who meet certain clinical criteria, Medicare doesn't. And neither do about 20 state Medicaid programs that follow Medicare's lead. Thus, Medicaid patients in those states can't get these devices, while those who have been using them for long periods of time both CGMs and OmniPod have been on the US market for over a decade are forced to give them up or pay out of pocket for the supplies when they age into Medicare. "[CMS officials] just want to be within the bounds of the law. But as a clinician I deal with all these headaches. When patients turn 65 they lose the OmniPod and CGM," George Grunberger, MD, head of the Grunberger Diabetes Institute, Bloomfield Hills, Michigan, and immediate past president of the American Association of Clinical Endocrinologists (AACE), explained to Medscape Medical News. Issue Relates to Definition of "Durable Medical Equipment" With both devices, the problem relates to the definition of "durable medical equipment," which applies solely to the active part of devices under Medicare Part B. In the case of CGMs, the "active" part the sensor inserted beneath the skin is discarded after being worn for 6 or 7 days (CGMs from Medtronic and Dexcom, respectively). Both systems also include battery-powered transmitters either rechargeable ( Continue reading >>

The Future Of Diabetes: My 3 Weeks On A Bionic Pancreas

The Future of Diabetes: My 3 Weeks on a Bionic Pancreas First, whats the status of the race towards an artificial pancreas? Ive been quietly watching from the sidelines for nearly the past two years as work on artificial pancreas algorithms and hardware has gotten much closer to becoming reality. Excitingly, we are now just under two years from having a wide selection of artificial pancreas options on the market! (pending FDA approval of course) The soonest looks like it will be Medtronics MiniMed 670G hybrid closed-loop system , which is currently in pivotal trials (pivotal or Phase 3 trials are the phase required by the FDA before devices can be marketed and sold to the public), with a potential launch in April 2017. Following closely is TypeZeros inControl system . Tandem , Insulet (of OmniPod fame and the only tubeless artificial pancreas trial device Im aware of), Bigfoot Biomedical and Beta Bionics are all aiming for pivotal trials in 2017 and would therefore potentially launch in 2018. Short of a cure, the release of these products is something Ive dreamed about for years. No longer having to check my blood sugar 8 to 12 times per day. No longer having to precisely measure the carbohydrate content of my food. No longer having to painstakingly calculate the correct carb:insulin ratio. And no longer having to worry as much about what I eat in general and constantly have to think about diabetes. I was lucky to hear about a study going on at Stanford for the artificial pancreas about 6 months ago and ended up taking part in a trial for the Beta Bionics version. Thats the same Beta Bionics, led by Ed Damiano, which just secured $5M for the planned 2017 pivotal trial to take their iLet Bionic Pancreas to market. If you dont know the Beta Bionics story, Ed gave an exce Continue reading >>

Dexcom, Insulet Unmoved By Medtronic

Raymond James & Associates On Friday, Medtronic announced that it received Food and Drug Administration approval for the MiniMed 530G, its next generation insulin pump and continuous glucose monitoring combo device, which features novel automated insulin suspend technology. While the introduction of this device is a modest headwind for both DexCom (ticker: DXCM) and Insulet (PODD) as it strengthens Medtronic's (MDT)... Continue reading >>

Insulet Has A Challenger For Medtronic On The Horizon

The rate of innovation in devices for type 1 diabetes patients has accelerated rapidly in recent years, with digital technology and medical devices converging to offer new control. Most recently, market leader Medtronic launched its MiniMed 670G – the first ‘hybrid closed loop’ device to be approved in the US. This partially automates the monitoring of blood glucose levels and insulin delivery via a pump – not quite an ‘artificial pancreas’ – but a significant step towards one. One challenger to Medtronic is Insulet. It already markets its Omnipod, the world’s first tubeless insulin management system, but has now released data for its own hybrid closed loop system. Called the Omnipod Horizon, the system could rival the MiniMed 670G, and offer the added convenience of a tubeless system. The device is an all-in-one pump and injector that sits on the skin. The company says this prevent any wastage of insulin, tangling and snagging of tubing, and overall greater convenience for patients. Users control the pod using a wireless programming unit. This lets users monitor blood glucose levels and administer extra ‘bolus’ insulin doses at mealtimes. Pushing a button on the unit inserts a thin cannula under the skin which delivers insulin according to the user’s blood sugar levels. The company presented results from the Horizon’s use in children at the ADA congress in San Diego. This study investigated components of the Omnipod Horizon, including a model predictive control (MPC) algorithm, which continuously measures blood glucose levels and delivers appropriate insulin doses in response. ‘Unique challenges’ Data from the feasibility study showed the Omnipod’s effectiveness in both paediatric and adolescent populations. Over 36 hours, 58 type-1 diabet Continue reading >>

Insulin Pump

An insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion therapy. The device configuration may vary depending on design. A traditional pump includes: the pump (including controls, processing module, and batteries) a disposable reservoir for insulin (inside the pump) a disposable infusion set, including a cannula for subcutaneous insertion (under the skin) and a tubing system to interface the insulin reservoir to the cannula. Other configurations are possible. For instance, more recent models may include disposable or semi-disposable designs for the pumping mechanism and may eliminate tubing from the infusion set. An insulin pump is an alternative to multiple daily injections of insulin by insulin syringes or an insulin pen and allows for intensive insulin therapy when used in conjunction with blood glucose monitoring and carb counting. Medical uses[edit] Advantages[edit] Users report better quality of life (QOL) compared to using other devices for administering insulin. The improvement in QOL is reported in type 1 and insulin-requiring type 2 diabetes subjects on pumps.[1] The use of rapid-acting insulin for basal needs offers relative freedom from a structured meal and exercise regime previously needed to control blood sugar with slow-acting insulin.[citation needed] Programmable basal rates allow for scheduled insulin deliveries of varying amounts at different times of the day. This is especially useful in controlling events such as the dawn phenomenon resulting in less low blood sugar during the night.[2] Many users feel that bolusing insulin from a pump is more convenient and discreet than injection.[2][3] Insulin pumps make it possible to deliver more pre Continue reading >>

Omnipod Feasibility Study Seeks To Perfect Formulas That Will Make Artificial Pancreas Run

Newsroom Published on: October 21, 2016 Omnipod Feasibility Study Seeks to Perfect Formulas That Will Make Artificial Pancreas Run Current work seeks to perfect the algorithm that would someday let the insulin pump automatically make the multitude of delivery decisions that would have been made by a healthy pancreas. Advances are happening alongside a shifting landscape in payer coverage, with advocates worried that they might lack choice amid so much innovation. For years, researchers around the globe have raced toward the holy grail in type 1 diabetes (T1D) care: the artificial pancreas, a device that delivers the right insulin dose without patient interaction, without extreme highs or lows in blood glucose, and with limited fear of overnight episodes of hypoglycemia that keep loved ones sleeping with one eye open. Last months FDA approval of Medtronics MIniMed 670G was the first acknowledged by JDRF as worthy of the artificial pancreas label, although it is a hybrid closed loop system, not what JDRF calls the end goal. Other manufacturers have devices at various stages of development, which advocates for the T1D community say is a good thingmore competition means innovation, choice, and, they hope, downward pressure on prices. In mid-September, Insulet Corporation announced that the first patient had completed a feasibility study for its Omnipod Horizon Automated Glucose Control System. Insulets entrant in the artificial pancreas market is an advance of its existing Omnipod tubeless insulin pump, which is compatible with different continuous glucose monitoring (CGM) systemsconsisting of a sensor, a transmitter, and a receiver that allows the patient to read data. Mobile CGM systems can send data to a patients smartphone, which makes monitoring their blood sugar disc Continue reading >>

Insulet Announces Development Partner For The Omnipod Artificial Pancreas

Insulet Announces Development Partner for the OmniPod Artificial Pancreas Company's Alliance with Algorithm Partner Marks Critical Step Forward in Advanced Diabetes Treatment Feb 25, 2016, 07:00 ET from Insulet Corporation BILLERICA, Mass., Feb. 25, 2016 /PRNewswire/ -- Insulet Corporation (NASDAQ: PODD ), the leader in tubeless insulin pump technology with its OmniPod Insulin Management System (OmniPod System), today announced a license agreement and partnership with Mode AGC (Automated Glucose Control LLC), to develop and incorporate the advanced artificial pancreas algorithm created by renowned researchers Francis Doyle PhD, Eyal Dassau PhD, and Howard Zisser MD. This alliance marks a significant step forward in Insulet's mission to improve the quality of life for individuals with insulin-dependent diabetes. Insulet's artificial pancreas system will use the innovative and differentiated OmniPod platform, the latest DexCom Continuous Glucose Monitoring (CGM) technology and the algorithm licensed from Mode AGC. The algorithm was created by Drs. Doyle, Dassau and Zisser during their tenure at the University of California, Santa Barbara, and further developed by Mode AGC,a California-based early-stage medical device company founded by prominent diabetes technology specialist Thomas Peyser PhD and diabetesadvocate and entrepreneur Jennifer Schneider MD. Over the last several months, Insulet has worked with Mode AGC and the inventors to optimize the performance of the algorithm for incorporation into a commercial product. Coupled with the unique tubeless OmniPod platform, this system will be poised to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes. "Insulet continues to m Continue reading >>