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Medtronic Minimed 670g Price

Medtronic Wins Artificial Pancreas Race With Fda Approval Of Minimed 670g

Medtronic Wins Artificial Pancreas Race With Fda Approval Of Minimed 670g

Wednesday was a great day for the diabetes community, Richard Bergenstal, a research clinician at the International Diabetes Center at Park Nicollet, told Medical Device Daily, soon after the FDA approved the first commercial device often referred to as an artificial pancreas. Medtronic plc’s Minimed 670g hybrid closed loop system is now approved for patients 14 years of age and older with type 1 diabetes. The device is designed to adjust insulin levels with little or no input from the user by measuring glucose levels every five minutes. The regulatory milestone came about three months after Medtronic submitted the pre-market approval (PMA) application for the Minimed 670G in late June and the company said at the time it expected approval sometime next year, with plans to launch the product next spring. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the 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. Currently the system includes a glucose-monitoring sensor that attaches to the body under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption, the FDA noted. The company gained access to the artificial pancreas technology through a $3.7 billion acquisition of Minimed Inc. about 15 years ago. Minimed’s main product at the time was an external pump, worn on a patient’s belt, to administer insulin continuously to people with type 1 diabetes. Since then, Medtronic has advanced the Continue reading >>

This Could Be The Biggest Breakthrough Ever For The 1.25 Million People With Type 1 Diabetes

This Could Be The Biggest Breakthrough Ever For The 1.25 Million People With Type 1 Diabetes

Often referred to as the "silent killer," diabetes in the U.S. is soaring. As of 2012, 29 million people had diabetes, up from 26 million in 2010. The majority were type 2 diabetics, which means their disease, which is caused by the body's inability to use insulin properly to convert sugar into energy, develops over time. Type 2 diabetics and prediabetics are often encouraged to change their eating and exercise habits to slow the progression of their disease. Type 1 diabetes is no laughing matter A much smaller percentage of the population -- 1.25 million children and adults -- have what's known as type 1 diabetes. Those with type 1 diabetes have little to no insulin production from their pancreas, and as the Mayo Clinic notes, it's often caused by genetics or perhaps exposure to specific viruses. Type 1 diabetics also, according to a recent study in Australia between 1997-2003 and 2004-2010, have a life expectancy that's 12.2 years less than the general population. The overwhelming number of type 2 diabetes cases compared with type 1 often seems to overshadow the seriousness of type 1 diabetes, as well as the struggles and inconveniences type 1 diabetics face in constantly monitoring their blood sugar levels. Per Reuters, more than a third of type 1 diabetics are utilizing an insulin pump to help regulate their blood sugar. Life as a type 1 diabetic isn't easy. However, that could be about to change thanks to what could be described as the biggest breakthrough ever gaining clearance well ahead of schedule from the U.S. Food and Drug Administration. The biggest breakthrough ever for type 1 diabetics As announced by medical device powerhouse Medtronic (NYSE:MDT) on Wednesday, the FDA has approved the company's "artificial pancreas" device known as the MiniMed 670G six mo Continue reading >>

Diabetes Double Play: Medtronic Launches Minimed 670g, Dexcom Wins Fda Nod For Android G5 App

Diabetes Double Play: Medtronic Launches Minimed 670g, Dexcom Wins Fda Nod For Android G5 App

UPDATE: Updated to include comments from Ascensia Medtronic (NYSE:MDT) and Dexcom (NSDQ:DXCM) today announced respective wins for their diabetes care tech, with Medtronic launching its hybrid closed loop MiniMed 670G in the US and Dexcom winning an FDA nod for a Google (NSDQ:GOOG) Android G5 Mobile application. Fridley, Minn.-based Medtronic’s MiniMed 670G is designed to automatically track and adjust blood sugar levels in patients with diabetes, measuring blood glucose every 5 minutes and automatically administering or withholding insulin. The newly launched system includes a body-attached sensor to track glucose levels under the skin, a worn insulin pump and an infusion patch connected to the pump with a catheter to deliver insulin. The device is designed to automatically adjust insulin levels, but requires manual entry of carbohydrates consumed and approval for bolus correction recommendations. “The response from the diabetes community has been tremendously positive and we are proud to be leading this remarkable period in diabetes history in partnership with the clinical and advocacy communities. We’ve essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting. We are very excited to see that real-world insights from our Customer Training Phase reinforce the positive outcomes demonstrated through our pivotal trial of the system,” intensive insulin management division prez Alejandro Galindo said in a prepared statement. The hybrid closed loop system features Medtronic’s SmartGuard algorithm, which the company says is the 1st step on its phased approach towards developing a fully automated, closed loop system. The MiniMed 670G also includes the company’s Guardia Continue reading >>

Artificial Pancreas Device:how Work?cost & Advantages

Artificial Pancreas Device:how Work?cost & Advantages

Artificial Pancreas Device: The Artificial Pancreas Device is a system that helps people with diabetes automatically regulate their blood glucose level by providing the substitute endocrine functionality of a healthy pancreas. Artificial Pancreas consists of three types of devices that previously familiar to many people with diabetes: Continuous Glucose Monitoring (CGM) and an insulin pump. A blood glucose device (glucose meter) is applied to calibrate the CGM. A computer-controlled algorithm connects the CGM and insulin pump to permit continuous communication attaching the two devices.An Artificial Pancreas Device System will not only monitors glucose levels but also automatically adjusts the delivery of insulin to overcome high blood glucose levels (hyperglycemia) and reduce the incidence of low blood glucose (hypoglycemia) with no input from the patient. An artificial pancreas device help people with type 1 diabetes manage their condition.The FDA recently approved it for treating type 1 diabetes in people age 14 and older. Medtronic’s hybrid closed-loop system, the world’s first “artificial pancreas,” (MiniMed 670G hybrid closed-loop system)in the U.S. market. The system is the only FDA-approved insulin pump that automatically delivers basal insulin to control blood glucose levels in people with Type 1 diabetes. Continue reading >>

Fda Approves The First Artificial Pancreas

Fda Approves The First Artificial Pancreas

Finally we have a breakthrough for diabetes type 1 management! The FDA has just approved the artificial pancreas – new technology aimed at helping those suffering from diabetes type 1 cope with their condition. About 1.25 million children and adults in the United States have type 1 diabetes, so this is exciting news for a lot of people. This artificial pancreas is also known as an automated insulin delivery device. It’s like an insulin pump but WAY smarter. An automated insulin delivery device works by continuously monitoring a patient’s glucose levels, and adjusting the patient’s insulin levels as needed. What is the significance of this approval? This approval is a first-of-its-kind technology! This is exciting news because it gives individuals with type 1 diabetes greater freedom to live their lives without worrying about glucose levels and insulin. What is the device? The automated insulin delivery device, or artificial pancreas, is made by MedTronics. It is called the MiniMed 670G. The MiniMed 670G is for use in type 1 diabetic patients 14 years of age, and older. How does the device work? Its (mostly) automatic! The MiniMed 670G automated insulin delivery system works by measuring glucose levels every 5 minutes, and automatically administering or withholding insulin. The one catch – patients will have to enter in the carbohydrates consumed at each meal. How does this differ from your typical insulin pump? The MiniMed 670G is considered an artificial pancreas because of its hybrid closed loop system. This means that the MiniMed 670G continuously monitors your glucose levels and adjusts accordingly. On the other hand, a standard insulin pump does not continuously monitor your glucose levels but rather requires the user to determine insulin levels. These pu Continue reading >>

How Much Do Diabetes Supplies/medications Cost In The U.s.?

How Much Do Diabetes Supplies/medications Cost In The U.s.?

While everyone’s diabetes treatment plan, medications, and technology may be different, there is one thing we can all agree on: diabetes is expensive. In two previous posts at The Perfect D, I gave some sense of what the bare minimum of care for a U.S. adult with Type 1 diabetes would be and also financial resources and programs to help with the financial burden of living with diabetes. However, this post is about how much it could cost an adult with Type 1 diabetes if they used the technology and medications that are currently out on the market (and thought of as “the latest and greatest”) and paid out of pocket with no insurance. Research on this topic has shown me that: 1) prices can fluctuate wildly, so it pays to shop around and 2) there is a very big gap (financially, medically, and technologically) between the bare minimum and “surviving” and actually utilizing the tools and latest technology that is out there. So, the hypothetical person for this exercise is a Type 1 adult in the United States who weighs 60kg, just like the other calculation post I did. Ground Rules These prices are accurate on the websites I have referenced for December 1, 2014. They may change, they may add shipping, they may not offer the services, technology, or drugs on their website after this is posted. These prices are not a guarantee. They are to be used as a reference. The listing of prices/websites on this post does not mean that I endorse the company or product or service. I have not listed all the products available on the market for people with Type 1 diabetes. I have listed major ones to give you an idea of major manufacturers’ costs for the products that are available for general public viewing. I did not call any companies and ask for pricing. Why? Because I believe Continue reading >>

The First ‘artificial Pancreas’ Systems Are Coming To Market

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 >>

New Diabetes Breakthrough

New Diabetes Breakthrough

PALM BEACH GARDENS, Fla. (CBS12) — There is a new breakthrough in the battle against diabetes and it is available right here in Palm Beach County. The FDA approved device that’s making it easier for people 14 years old or older to manage their Type 1 diabetes. “I enjoy sports and I enjoy fishing, too,” said Colton Smith. Colton is a junior at Jupiter Christian School where he plays football. His life changed when doctors diagnosed him with Type 1 diabetes two years ago. “I have to take insulin before I eat every time,” Colton said. He carried needles and pens with him 24-7, but that’s come to an end. Now he’s carrying around this insulin pump called the MiniMed 670G by Medtronic. “Going from eight injections a day to one injection two to three days is definitely life-changing,” said Dr. Miladys Palau, Pediatric Endocrinologist at Nicklaus Children's Palm Beach Gardens Outpatient Center. Palau explained how the automated pump differs to other insulin pumps. “Essentially the sensor is sending a message to the pump every five minutes telling the pump what is the blood sugar, how fast it’s going up or going down. So the pump can calculate precise insulin doses to give to the patient,” Palau said. “I’ve heard some mothers say they haven’t slept a wink since their kid has been diagnosed,” said Barbara Nicklaus. Barbara, the wife of golf great Jack Nicklaus, said she’s happy to see mothers like Colton’s, have some sense of peace. “He can just go out and be free,” Jean Smith said. Being able to hit the football field without worrying about his health. “I am able to enjoy the things I do more often and not worry about it while I am doing these things,” Colton said. The MiniMed 670G system is commercially available at currently offere Continue reading >>

We Finally Have An “artificial Pancreas” For Diabetes. But It's A Letdown.

We Finally Have An “artificial Pancreas” For Diabetes. But It's A Letdown.

Melinda Wedding The first thing Melinda Wedding thinks about when she wakes at 6:15 am is checking her daughter Carson’s blood sugar to see if she needs another dose of insulin. "Type 1 diabetes is constant," Wedding told me. "There’s no downtime." Throughout the day she might look at her watch, which gives her a reading of her daughter’s blood sugar, up to 100 times. With that data comes hundreds of decisions about when Carson should eat and how to use her insulin pump. Every night, Wedding wakes up two or three times to check on her daughter’s blood levels again. If Carson misses a dose of insulin — and she sometimes does as she learns to manage her condition — her blood sugar will rise. Over time, that could lead to all sorts of adverse effects, from brain fogs and stomachaches to a coma or kidney failure. You'd think that a new device called the "artificial pancreas" would be a godsend for someone like her. Designed to make insulin delivery less of a hassle by automating it, the MiniMed 670G by Medtronic was called "revolutionary" and a game changer after the Food and Drug Administration approved it in September. But families like the Weddings say the device, slated to hit the market in spring 2017, has been incredibly overhyped. For starters, it isn’t a true artificial pancreas — it only automates the delivery of one type of insulin — and patients who use it still have to do a lot to manage their condition. "I hate [the name]," Wedding summed up. "It gives the connotation that the problem is solved, when it’s far from solved." The device also does nothing to fix one of the most pressing problems facing the 1 million people with Type 1 diabetes in America: The cost of insulin is skyrocketing so much that some patients are being forced to cut back Continue reading >>

Your Questions Answered: The Minimed 670g System

Your Questions Answered: The Minimed 670g System

In September, the FDA approved a big leap forward in diabetes technology, the world’s first hybrid closed loop system. The MiniMed® 670G system is designed for people with type 1 diabetes who are 14 and older. Having been diagnosed with type 1 in 1989, when blood glucose meters were bigger than the current larger iPhone, this seems amazing! The Glu team recently connected with Chief Patient officer Louis Dias about the reveal of the highly anticipated MiniMed 670G product. Let’s hear what he had to say! GluAnna: Why is the MiniMed 670G system such an important innovation in today’s world? Louis: This system is important because it has the potential to dramatically change the way individuals and families deal with the highs and lows of diabetes. What we heard from so many of the people who participated in the clinical trial was how different it made them feel both physically and emotionally, giving them that peace of mind that can be so elusive in a life with diabetes. GluAnna: That’s great! So what is new about this particular model that patients can expect from either older models or users brand new to pump therapy? Louis: If you have the product in hand, you now have the opportunity to put the device in Auto Mode, where the pump automatically adjusts the delivery of your basal insulin based on readings from our most advanced CGM sensor, called the Guardian® Sensor 3. Auto Mode works to keep you at 120 mg/dl. Instead of you always making the adjustments, testing different basal rates and basal patterns to try to match the amount of insulin you need for different times of day and activities, about every 5 minutes the system determines how much insulin to give you, based on the sensor reading – taking more than a few math problems off of your plate. It also g Continue reading >>

Kid On Cutting Edge In Diabetes Trial

Kid On Cutting Edge In Diabetes Trial

Jackson 6-year-old tests new insulin pump for Type 1 youngsters. Cashs mom, Mills Halpin, encourages him to eat more chicken at dinner with his brother in late June. Getting the right amount of carbs can be a guessing game because sometimes he doesnt eat everything, she said. Cash Halpin shovels the last bite of rice into his mouth and asks for another serving. I ate all the carbs, he proudly announces, mouth still full. Yeah, says his mother, Mills Halpin, who rolls her eyes at her 6-year-old son. Eat some protein. His father, Mike Halpin, is beside him on an opened laptop, checking the latest data available from Cashs insulin pump. The boy is part of a clinical trial testing the Medtronic MiniMed670G, a system capable of continuously monitoring his glucose levels and making microadjustments to keep them consistent throughout the day. Cash is in the youngest group of participants to be tested, ages 2 to 6. The same Medtronic model was approved by the U.S. Food and Drug Administration last fall for ages 14 and up. Mike Halpin administers about a unit of insulin, a tiny bubble of hormone to handle the approximately 35 grams of carbs Cash is consuming for dinner. Manual adjustments are still required at mealtimes, but the new system offers his parents a little reprieve, something they havent experienced since hewas diagnosed three years ago. Halpin has to wear an insulin pump at all times, which monitors his levels and injects insulin when needed through an infusion port under his skin. With this new system, if they are off a little you just cant be exact all the time, Mills Halpin says the pump can adjust for it. I still dont know how people did this 10 years ago, she says. I just hug any family who has diabetic kids in their 20s and 30s. Mills Halpin knew what was happ Continue reading >>

Medical Policy Subject: Continuous Glucose Monitoring

Medical Policy Subject: Continuous Glucose Monitoring

SYSTEMS/ EXTERNAL INSULIN PUMP THERAPY FOR DIABETES POLICY NUMBER: 1.01.30 CATEGORY: Technology Assessment PAGE: 1 OF: 11 ï‚· If a product excludes coverage for a service, it is not covered, and medical policy criteria do not apply. ï‚· If a commercial product, including an Essential Plan product, covers a specific service, medical policy criteria apply to the benefit. ï‚· If a Medicare product covers a specific service, and there is no national or local Medicare coverage decision for the service, medical policy criteria apply to the benefit. Proprietary Information of Excellus Health Plan, Inc. A nonprofit independent licensee of the BlueCross BlueShield Association POLICY STATEMENT: INITIAL Requests for insulin pump therapy (HCPCS: E0784) I. Based upon our criteria and review of the peer-reviewed literature, basic external insulin pumps are medically appropriate when the patient: A. has completed a comprehensive diabetes education program, and B. has been on a program of multiple daily injections of insulin (at least 3 per day), with frequent self-adjustments of insulin dose for at least 6 months prior to initiation of the insulin pump, and C. has documented frequency of glucose self-testing an average of at least 4 times per day during the 2 months prior to initiation of the insulin pump, and D. meets one or more of the following criteria while on the multiple injection regimen: 1. HbA1C greater than 7% within the last four months; or 2. History of recurring hypoglycemia; or 3. Wide fluctuations in blood glucose before mealtime; or 4. Dawn phenomenon with fasting blood sugars frequently exceeding 200 mg/dL; or 5. History of severe glycemic excursions. II. Insulin pump therapy is medically appropriate for women with gestational diabetes who: 1. Require ins Continue reading >>

The Minimed 670g

The Minimed 670g

The 670g is here! Now what? To begin with, I’m not going to get hung up on how they name this system, because really, I care more about what it can do. At some point, I might or might not talk about JDRF’s decision to label this an artificial pancreas. But that’s another discussion for another day. Okay… where was I? That’s right, the hybrid closed loop system that was approved by the U.S. Food and Drug Administration on Wednesday. There is a lot to cover. Here we go: 1. First, I’d like to offer this quote from Medtronic Diabetes CEO Hooman Hakami, who posted this on Wednesday: ”This approval is a significant milestone in the history of diabetes management, and a culmination of many years of dedicated work. With this approval, we are one step closer to delivering a fully automated closed loop system.” All of this is true. They’ve been working on it for a while, using many resources, conducting many clinical trials. And true, it’s not quite yet a fully automated closed loop system (which would be many people’s definition of an artificial pancreas). I should mention that during the Medtronic Diabetes Advocates Forum back in April, we talked about artificial pancreas terminology, and “hybrid closed loop system” was terminology that was mentioned. Kind of like, “what would you think if we used the term hybrid closed loop (I’m paraphrasing)? I remember thinking, “well, tell me what that means and I’ll tell you whether I like it”. I suspect others in attendance might have thought the same thing, and I understand now why Medtronic couldn’t reveal why they brought up that terminology. Now, before I get too far off topic… 2. It’s not fully automated? What’s not automated? The system has algorithms to help determine your insulin needs. Continue reading >>

Newsflash: Fda Approves Medtronic 670g As First-ever Hybrid Closed Loop!

Newsflash: Fda Approves Medtronic 670g As First-ever Hybrid Closed Loop!

Wow, what a huge moment for the Diabetes Community! On Wednesday, the FDA approved Medtronic's Minimed 670G, the first-ever "hybrid closed loop system" that can automatically monitor glucose and adjust basal insulin doses in people 14 years of age and older with type 1 diabetes. This comes with a firestorm of excitement because it is of course the closest thing to an FDA-approved "Artificial Pancreas (AP) System" ever to hit the market, yet there are also community grumblings about how the AP label is being used to describe this new technology. While we in the Diabetes Community realize that it's not a fully closed-loop AP that takes over diabetes control completely, and Medtronic itself is being careful to refer to it as a "hybrid," the new Minimed 670G represents a HUGE step forward in automating our disease management. Woot! Here's the official letter from the FDA to Medtronic about this clearance, as well as the FDA news release. Remarkably, this regulatory approval comes only 104 days (!) after Medtronic submitted thousands of pages of documents, which is seven months earlier than expected and this approval caps more than a decade of research, policy, and product development in getting to this milestone. “This is phenomenal, and I’m so psyched!” says Aaron Kowalski, Chief Mission Officer of the JDRF and longtime type 1 himself. “It’s amazing to be at this level. Think about it -- this is the first time one of these (automated systems) has been approved… and the short time it took the FDA to clear this. " So, just what is this new glucose control system, and how does it work? What's a Hybrid Closed Loop? The term "hybrid" in this case means the system is partially automated but still requires some control by the user. The way it functions is that the CGM Continue reading >>

Diabetes Treatment Set To Be Revolutionised After Scientific Breakthrough

Diabetes Treatment Set To Be Revolutionised After Scientific Breakthrough

Scientists have developed an artificial pancreas set to revolutionise the treatment of diabetes . The ground-breaking device, hailed in the US as a "game changer" in controlling the disease, checks blood sugar levels and delivers life-saving insulin as required. The device has been trialled on patients in the UK and could soon become routinely available. Sarah Johnson, a director at JDRF, the Type 1 diabetes charity, said: "We have been funding research for this breakthrough for over a decade. We are incredibly excited about it. Our next effort will be to get UK regulatory approval and get it to people through the NHS .” Professor Bruce Buckingham, a specialist in diabetes at Stanford University, California, who helped run trials of the system, said: "This is a real game changer in controlling blood glucose levels and a revolution in diabetes treatment. "It has been shown to work in Type 1 diabetes patients, but it could also be used on people with Type 2.” The MiniMed 670G can be implanted anywhere on the body. It features a sensor the size of a large coin that monitors glucose levels and a separate insulin pump, the size of a wafer-thin matchbox, that responds to the monitor and automatically infuses insulin into the body as needed via a catheter. This frees patients of the need constantly to check blood glucose levels and deliver their own insulin injections to avoid serious complications, including sudden death if blood sugar plunges too low. All people with Type 1 diabetes and many with insulin-dependent Type 2 must constantly check their blood sugar throughout the day, injecting insulin according to what they eat and how much they exercise. The news comes as figures released to this paper from NHS Digital reveal the number of people with Type 2 diabetes - asso Continue reading >>

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