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Closed Loop Insulin Pump

First Impressions Of Medtronic's 670g Hybrid Closed Loop

First Impressions Of Medtronic's 670g Hybrid Closed Loop

Anyone touched by type 1 diabetes has to be excited about the FDA's recent approval of the first pre-Artificial Pancreas system, the Medtronic Minimed 670G. It's a milestone towards ever-more-sophisticated automated insulin delivery! Today, we're thrilled to have our correspondent Wil Dubois walk us through a hands-on initial review of this exciting new system. Test-Driving the Medronic 670G, 'Future of Diabetes Technology' Everything about Medtronic’s new Minimed 670G hybrid closed loop insulin pump is so different that it requires a substantial shift in mindset. Like one of those team-building exercises where you cross your hands and fall backwards, counting on your peers to catch you, the 670G requires us to let go of elements of diabetes control that for years have bordered on sacred. Why? Because this pump isn’t like anything we’ve ever seen before. In fact, it isn’t like any diabetes therapy we’ve ever seen before. What the 670G Does and Doesn't Do How many times have you started your day high, even though you went to bed on-target and haven’t eaten for 8, 10, or more hours? How would you like a pump that could see you were drifting up while you slept, and just automatically gave you more insulin to fix the problem? Or a pump that could see that you are drifting down during a hard day’s work and shut off the flow of insulin to prevent a low? That’s the promise of the 670G. It’s designed to track changes in your blood sugar via a CGM, and keep you in target by automatically delivering “micro boluses” or withholding insulin—replacing a traditional fixed basal rate. All 670G users need to do is count carbs and enter them into the pump when they are going to eat. So, how well does it live up to its promise? Well… OK, first things first. The p Continue reading >>

Hybrid Closed Loop Insulin Delivery System

Hybrid Closed Loop Insulin Delivery System

International Diabetes Center St. Louis Park, MN Real World Experience with the Shannon Beasley MSN, APRN, CPNP, CDE Pediatric Endocrinology Nurse Practitioner Park Nicollet HealthPartners Minneapolis, MN [email protected] Beth A. Olson BAN, RN, CDE Program Manager, Research International Diabetes Center Minneapolis, MN [email protected] Disclosure to Participants • Notice of Requirements For Successful Completion – Please refer to learning goals and objectives – Learners must attend the full activity and complete the evaluation in order to claim continuing education credit/hours • Conflict of Interest (COI) and Financial Relationship Disclosures: – Shannon Beasley, MSN, APRN, CPNP, CDE – No COI/Financial Relationship to disclose – Beth Olson: BAN, RN, CDE– No COI/Financial Relationship to disclose • Non-Endorsement of Products: – Accredited status does not imply endorsement by AADE, ANCC, ACPE or CDR of any commercial products displayed in conjunction with this educational activity • Off-Label Use: – Participants will be notified by speakers to any product used for a purpose other than for which it was approved by the Food and Drug Administration. Learning Objectives • Describe the impact of the 670G Hybrid Closed Loop system on safety and efficacy of glycemic parameters • Explore the practical applications for implementation of the Hybrid Closed Loop system • Address patient, caregivers’ and provider expectations of the 670G Hybrid Closed Loop system 7/18/2017 2 Evolution of Pump Therapy Insulin Pumps Accuchek Combo Animas One Touch PingMedtronic 530G with Enlite CGM Tandem T-Slim Animas Vibe with DexCom Insulet Omnipod Medtronic 630G Avera Continue reading >>

Insulin Pump

Insulin Pump

There are a number of insulin pumps manufactured between 2006 – 2012 by Medtronic which are compatible. Compatibility has two requirements; (1) pump model and (2) firmware. The Loop-compatible pumps are as follows: Insulin Pump MM 515/715 MM 522/7222 MM 523/7233 MM 554/7544 CGM Dexcom G41 ✅ ✅ ✅ ✅ Dexcom G5 ✅ ✅ ✅ ✅ MM CGM ✅ ✅ ✅ ✅ 1. Offline access to glucose requires a Receiver with Share and the Share2 app to be running on the same iPhone as the Loop app is installed. Internet-dependent access via Share servers is also supported. 2. x22 model pumps were produced before firmware security patches were implemented, therefore these models are compatible because they will have firmware 2.4A or lower only. You can double check, but thus far all x22 pumps we have seen have compatible firmware. 3. Firmware 2.4A or lower is required for using Closed Loop and Bolus features. 4. Worldwide Veo (2.6A or lower) or Canadian/Australian Veo (2.7A or lower) is required for using Closed Loop and Bolus features. US version of this pump is not available. If you want to triple check compatibility, you can check for presence/absence of "PC connect" in the pump. If PC Connect is present, then the pump is NOT compatible. You can find PC connect in the Medtronic's Main Menu, Utilities, Connect Devices. PC Connect, if present, will be the first option showing in that menu, above the word "Meters". If you do NOT see PC Connect there...good! Pump Model To determine your pump model, look at the back side of your pump. There should be a sticker on the underside of the pump. On the right hand side of the sticker, it says REF MMT-XXXXXX MMT Pump Manufacturer Model (MiniMed Medtronic) 722 Pump Model Number NA Pump Region (NA=North America, CA=Canada/Australia, WW=Worldwide) S P Continue reading >>

Beta Cells Vs. Closed-loop Pumps Which Is Better?

Beta Cells Vs. Closed-loop Pumps Which Is Better?

Read more: How to Grow Beta Cells in 40 Days However, this seemingly large supply of beta cells still doesnt solve all problems with the transplant process. People with Type 1 diabetes who undergo islet therapy must take drugs to suppress their immune systems or their bodies will destroy the transplanted beta cells. There also is still room for improvement in quality of the grown cells. Currently, the best beta cells grown in the lab match the poorest quality of beta cells made naturally in the body. Millman believes the quality of cells grown in the lab will only improve in the coming years. Making beta cells is pretty much figured out, he said. These cells will be quite good just a few years from now. But while Millman can point to successful transplants involving individual patients, the number of patients who have successfully worn closed-loop insulin pumps number in the thousands, and that made Kowalskis case much easier to argue. Kowalskis argument was simple closed loop pumps work and they make the lives of people with Type 1 easier right now. To buoy his case, he came armed with statistics that JDRF advocates often cite, including that studies have shown that most people with Type 1 diabetes arent meeting the A1C goals necessary to avoid long-term complications. Kowalski and others at JDRF say that this isnt because people arent trying; its just that the task of being ones own pancreas is extremely difficult. Hybrid closed loop pumps make that task easier, he said. In trials, the pumps, which still require individuals to bolus for meals, have been shown to significantly reduce glucose variation and improve A1C scores. These trials have also shown that closed loop pump technology had the greatest impact when people with Type 1 were asleep and cant manage their g Continue reading >>

Hybrid Closed-loop System Demonstrates Effectiveness In Controlling Glucose Levels In Children And Adults With Type 1 Diabetes

Hybrid Closed-loop System Demonstrates Effectiveness In Controlling Glucose Levels In Children And Adults With Type 1 Diabetes

Hybrid Closed-Loop System Demonstrates Effectiveness in Controlling Glucose Levels in Children and Adults with Type 1 Diabetes Closed-loop systems safe for daytime and overnight use, and to reduce exercise-induced hypoglycemia For people with type 1 diabetes, continuous glucose monitoring (CGM) devices provide around-the-clock information on blood glucose levels. Insulin pumps allow insulin to be administered subcutaneously throughout the day. Over the recent past, researchers combined the technology of CGM and insulin pumps to form closed-loop systems, which allow people with diabetes to receive insulin through a pump continuously throughout the day and night based on the glucose measurements provided every five minutes by the CGM. The performance of closed-loop systems and their ability to prevent hypoglycemia is highlighted in two studies presented at the American Diabetes Associations 77th Scientific Sessions at the San Diego Convention Center. Safety and Feasibility of Omnipod Hybrid Closed-Loop in Children Aged 6-12 Years with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm Children with type 1 diabetes have increased insulin sensitivity compared to adolescents and adults, and are at increased risk of severe hypoglycemia (low blood glucose levels) overnight. This inpatient, research center study investigated the safety and feasibility of a new hybrid closed-loop system. Researchers combined an Omnipod patch pump, Dexcom, G4 CGM sensor with Bluetooth technology built into the receiver, and a personalized model, predictive control algorithm. Hybrid closed-loop, indicates that the system is continuously adjusting insulin delivery. However, at mealtime, the patient enters the amount of carbohydrates they are eating in order for the insulin pum Continue reading >>

Closed-loop Insulin Delivery For Treatment Of Type 1 Diabetes

Closed-loop Insulin Delivery For Treatment Of Type 1 Diabetes

Abstract Type 1 diabetes is one of the most common endocrine problems in childhood and adolescence, and remains a serious chronic disorder with increased morbidity and mortality, and reduced quality of life. Technological innovations positively affect the management of type 1 diabetes. Closed-loop insulin delivery (artificial pancreas) is a recent medical innovation, aiming to reduce the risk of hypoglycemia while achieving tight control of glucose. Characterized by real-time glucose-responsive insulin administration, closed-loop systems combine glucose-sensing and insulin-delivery components. In the most viable and researched configuration, a disposable sensor measures interstitial glucose levels, which are fed into a control algorithm controlling delivery of a rapid-acting insulin analog into the subcutaneous tissue by an insulin pump. Research progress builds on an increasing use of insulin pumps and availability of glucose monitors. We review the current status of insulin delivery, focusing on clinical evaluations of closed-loop systems. Future goals are outlined, and benefits and limitations of closed-loop therapy contrasted. The clinical utility of these systems is constrained by inaccuracies in glucose sensing, inter- and intra-patient variability, and delays due to absorption of insulin from the subcutaneous tissue, all of which are being gradually addressed. Challenges for type 1 diabetes management Type 1 diabetes is a chronic disease caused by T-cell-mediated autoimmune destruction of the pancreatic β cells in genetically predisposed individuals [1]. Insulin discovery in the early 1920s transformed diabetes from a uniformly fatal condition into a disease requiring life-long insulin-replacement therapy. The Diabetes Control and Complication Trial linked tight Continue reading >>

(c) 2015-2017 Dana Lewis & The #openaps Community. Openaps™, #openaps™, Openaps™, And All Derivatives Of The Name Are Trademarks Of Dana Lewis & The #openaps Community And Are Not Authorized For Use By Any Commercial Entity. Contact: Dana@openaps.org

(c) 2015-2017 Dana Lewis & The #openaps Community. Openaps™, #openaps™, Openaps™, And All Derivatives Of The Name Are Trademarks Of Dana Lewis & The #openaps Community And Are Not Authorized For Use By Any Commercial Entity. Contact: [email protected]

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 >>

Pipeline

Pipeline

Our #1-rated California-based Customer Support Team is available 24 hours per day and 365 days per year. Changing the face of insulin pump therapy The information below discusses development programs not approved by the FDA. This information is intended for investors researching the company, and is updated in conjunction with public announcements about our product pipeline. All dates below are as of March 1, 2018. Tandem undertakes no obligation to update or review any forward-looking information below based on new information, future events or other factors. From the beginning, we have taken a unique approach to product development. All of our products have been developed through an extensive, user-centric process involving thousands of interviews with pump users and healthcare providers. In addition, we have employed Human Factors research heavily in our development process. The first product from these efforts was the t:slim Insulin Pump, the first-generation touchscreen pump which consistently ranked #1 by pump users in independent research.1 Since then, we have also developed the Tandem Device Updater to deliver remote software updates for our insulin pumps through a customers personal computer, and a second-generation pump, the t:slim X2 Insulin Pump that builds on the original with a variety of improvements including an advanced Bluetooth radio for communication with future technologies.2 Below is a list of products we are working on for people with diabetes that continue our commitment to user-centric design and development. Continue reading >>

Diabetes And The Artificial Pancreas: Closed-loop Systems

Diabetes And The Artificial Pancreas: Closed-loop Systems

An article I read recently declared that the artificial pancreas, or a closed-loop artificial pancreas system for diabetes management, is likely to hit the market by 2018. This is potentially life-altering news for anyone with Type 1 diabetes — this is the next step in diabetes care that we have been waiting for. But what is a closed-loop artificial pancreas system, and what are the details researchers need to iron out for such a system to truly be a viable day-to-day option for diabetes management? A closed-loop artificial pancreas system is a device, or series of devices, that can work in concert with one another to automatically give the correct amount of insulin in response to food intake and rising blood glucose. There is also research into dual-hormone systems — these would provide insulin in response to rising blood sugars, and provide glucagon in response to falling blood sugars. However, the current formulations of glucagon are not as stable as would be ideal, and the reservoir would have to be replaced every 24 hours. The most likely candidate for release in the near future is a closed-loop artificial pancreas system that only supplies insulin. Such a system would be much less likely to CAUSE hypoglycemia, but on the occasions when hypoglycemia does occur, it would simply alert the user of low blood sugar and still require us to eat some of our good old glucose tablets. So now that we know what a closed-loop artificial pancreas system is, we need to know the components researchers will address in the next couple of years to make the bold prediction of 2018 a reality. Let’s take a look. 1. Glucose monitoring Obviously, accurate and continuous glucose monitoring (CGM) is absolutely vital in implementing a closed-loop artificial pancreas system. CGM systems Continue reading >>

Hybrid Closed-loop Insulin Delivery Systems For Type 1 Diabetes Come Of Age

Hybrid Closed-loop Insulin Delivery Systems For Type 1 Diabetes Come Of Age

At 19 months old, Jamie Kurtzig was diagnosed with Type 1 diabetes. For the next 10 years, her parents would wake up every three hours during the night to prick their daughter’s finger so they could check her blood glucose level. If her blood glucose was too low, they gave her food to avoid seizures or a loss of consciousness. If it was too high, they gave her an insulin injection to bring the level down to a normal range. “It’s caused a kind of PTSD for my husband and me,” said Sara Kurtzig, who lives with her daughter and husband in Marin, California. But for the past year, they’ve been able to sleep through most nights. That’s because Jamie started using a hybrid closed-loop insulin delivery system in 2016, thanks to a clinical trial at Lucile Packard Children’s Hospital Stanford and Stanford Medicine that assessed the system’s use in children ages 7 to 14. “The closed-loop system has completely changed our lives,” Sara said. “It took me a month to trust it, but now I can go to bed at 11 p.m. and wake up at 6:30 a.m. almost every night.” The system is among the methods being tested by researchers at the School of Medicine and Lucile Packard Children’s Hospital in their efforts to find easier ways for younger children with Type 1 diabetes to get the doses of insulin they need. Bruce Buckingham, MD, professor of pediatric endocrinology, directs clinical trials of the closed-loop system, which modulates insulin delivery based on glucose sensor readings measured every five minutes. He called the system a “historic advance” for diabetes care. “With this system, patients can achieve very reliable and safe overnight glucose control, mitigating overnight highs and lows with minimal manual intervention,” said Buckingham, who treats patients a Continue reading >>

Pilot Study Completed For Closed Loop Insulin Pump

Pilot Study Completed For Closed Loop Insulin Pump

Pilot Study Completed for Closed Loop Insulin Pump Tandem Diabetes Care, Inc. reported that a successful pilot study was completed on the companys t:slim X2 Insulin Pump, utilizing a hybrid closed-loop system that utilizes algorithms from TypeZero Technologies and Dexcom's G6 continuous glucose monitoring. The study is the first of 3 in the International Diabetes Closed Loop (IDCL) trial, funded by the National Institute of Health (NIH). It was a 36- to 48-hour study with 5 participants at the University of Virginia. The second of the 3 studies, which will be last 2 weeks, is currently enrolling patients at 7 clinical sites and is expected to begin in early 2018. We have enjoyed introducing patients to this latest advancement in technology, featuring an easy-to-use system and an algorithm with a successful track record in past clinical trials of improving blood glucose control while simultaneously decreasing hypoglycemia, Sue Brown, MD, an associate professor at the Center for Diabetes Technology at the University of Virginia and the endocrinologist in charge of the IDCL trials that utilize the embedded technology, said in a statement . This study was an exciting step forward in closed-loop technology for people with diabetes. The IDCL trial began near the end of 2016, and will include close to 360 adults with type 1 diabetes in total. A premarket approval submission is expected to be given to the US Food and Drug Administration (FDA) upon the completion of the trio of trials. The first successful use of the commercial version of our hybrid closed-loop system is a huge step forward, and the speed of the development cycle for this product has been impressive for our industry, Kim Blickenstaff, MBA, president and CEO of Tandem Diabetes Care, said in a statement. We look Continue reading >>

Closed Loop Systems: Future Treatment For Diabetes?

Closed Loop Systems: Future Treatment For Diabetes?

Having Type 1 Diabetes sometimes seems like a chore, testing, needles, making sure you’re eating correctly, and more. There are some days it’s just all too overwhelming. With technology moving faster than ever, you’d think there would be an easier way than sticking your finger every few hours and then figuring out how much insulin to inject. There is good news for those with Type 1 diabetes, science and technology have finally come together to create the artificial pancreas. We’re just a few small steps away from not having to wake our children up in the middle of the night to test their blood glucose levels. Or what if you didn’t have to worry about being late to a meeting because you were injecting insulin? Companies like Medtronic have paved the way into bionic management of Type 1 Diabetes and their device could be coming to you sooner than you think. What’s an Artificial Pancreas? Unlike the name implies, an artificial pancreas does not work exactly like a person’s biological pancreas. It is a device, not an organ, that requires a system of pumps, monitors, and algorithms to deliver insulin and glucagon directly to the patient. It’s not surgically implanted into a patient, rather it’s attached to the patient’s abdomen, on the outside of their body. Artificial pancreas’ are only for patients with Type 1 Diabetes. The system automatically monitors blood glucose levels, every 5 minutes, and provides the right dose of insulin or glucagon if needed. Algorithms are set in place which link the monitor to the pump. Some other names for the artificial pancreas include closed loop device and bionic pancreas. Patients who have an artificial pancreas will have more freedom and less stress about having to test, monitor, and administer medications for their Continue reading >>

Hybrid Closed Loop System.

Hybrid Closed Loop System.

NEW! The Suspend before low§ option avoids lows and rebound highs proactively by automatically stopping insulin 30 minutes before you reach your pre-selected low limits, then automatically restarts insulin when your levels recover, all without bothersome alerts. NEW! The Auto Mode‡ option automatically adjusts your basal insulin delivery every 5 minutes based on your sugar levels to keep you in target range, all day and night. Watch Video View Brochure Get Started NEW! Guardian® Sensor 3 continuous glucose monitoring sensor. Introducing the most accurate sensor from Medtronic, now with up to 7 day wear and easy insertion. It is the FIRST and ONLY continuous glucose monitoring sensor FDA approved and trusted to control insulin dosing. Exclusive CONTOUR®NEXT LINK 2.4 meter1 Get easy and accurate CGM calibration, insulin dosing and remote bolusing with our exclusive meter. “This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the time,” “It’s a medical device with the potential to change the lives of more than 1 million Americans who suffer from Type 1 diabetes.” KEEP YOUR GLUCOSE IN RANGE SMARTGUARD® HCL TECHNOLOGY. Quick and easy access to your glucose and insulin information, all from the home screen. Bright color screen for easy readability - day or night. Waterproof - so you can enjoy underwater activities. Quick and easy bolus from your meter. Fewer shots than multiple daily injections. The only sensor FDA approved and trusted to control insulin dosing. Easy to insert. Know at all times where your glucose levels are trending. Click here for assistance if your insurance does not currently cover the MiniMed 670G system. * Mean Absolute Relative Difference. ** 3-4 calibrations per day required. Continue reading >>

Medtronic Launches 670g – First Hybrid, Closed-loop System

Medtronic Launches 670g – First Hybrid, Closed-loop System

At times dubbed an artificial pancreas, the 670G represents a leap forward in automated insulin delivery. Medtronic announced in a press release that its 670G insulin pump system is officially hitting the U.S. market. The FDA approved the system for people with Type 1 diabetes ages 14 and older in September 2016. sponsor The 670G is the first hybrid, closed-loop insulin pump system for sale in the U.S. The pump can automatically adjust basal insulin delivery based on glucose readings, but users will still need to manually bolus with the device. The 670G has been called an artificial pancreas, including at times by this publication, but Medtronic is careful not to use the term in its publicity material. As Medtronic stated in its press release, researchers found in a pivotal clinical trial that use of the 670G helped users have less variability in glycemic levels, more time in a good glycemic target range, reduced risk of hyperglycemia and hypoglycemia, and somewhat improved A1C levels. Pharmaceutical companies often must take several months after FDA approval to build up manufacturing capabilities and sales force capacity for a new product before it officially launches. Medtronic originally predicted it would begin selling the 670G in the U.S. in Spring 2017; the company met that deadline with just two weeks to spare. The announcement allows Medtronic to enjoy a good news cycle. The company recently has endured several issues with its diabetes product line. In May, the company warned that a rapid change in air pressure could cause the buttons of several different models of its insulin pumps to stick. In February, the device manufacturer warned of a software problem with the Medtronic 640G pump that may prevent its internal battery from charging. And in January Medtronic Continue reading >>

Automated Insulin Delivery

Automated Insulin Delivery

The development of automated insulin delivery has many names artificial pancreas, hybrid closed loop, Bionic Pancreas, predictive low glucose suspendbut all share the same goal: using continuous glucose monitors (CGMs) and smart algorithms that decide how much insulin to deliver via pump. The goal of these products is to reduce/eliminate hypoglycemia, improve time-in-range, and reduce hyperglycemia especially overnight. See below for an overview of the automated insulin delivery field, focused on companies working to get products approved. Do-it-yourself automated insulin delivery systems like OpenAPS and Loop are not included here, though they are currently available and used by a growing number of motivated, curious users. Weve also included helpful links to articles on specific product and research updates, as well as some key questions . Whois Closing the Loop and How Fast Are They Moving? Below we include a list of organizations working to bring automated insulin delivery products to market this includes their most recently announced public plans for pivotal studies, FDA submissions, and commercial launch. The organizations are ordered from shortest to longest time to a pivotal study, though these are subject to change. This list excludes those without a commercial path to market (e.g., academic groups). The first table focuses on the US, with European-only systems listed in the second table . MiniMed 670G/Guardian Sensor 3 hybrid closed loop that automates basal insulin delivery (still requires meal boluses) FDA-approved and currently launching this fall to ~35,000 Priority Access Program participants in the US. Pump shipments to non-Priority Access customers will start in October, with sensors and transmitters to ship by the end of 2017 or early 2018. Medtronic Continue reading >>

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