Medtronic Minimed 670g System Review
After months of waiting, I finally received the world’s first hybrid closed loop system, the Minimed 670G system. Medtronic’s Minimed 670G system is an insulin pump and continuous glucose monitor that also has technology to put you in “auto” mode where it will automatically adjust your basal insulin every 5 minutes based on your blood sugar levels. I’ve had the system for about two weeks now so I thought I’d share my thoughts on it. I’m going to break this down into two posts because I feel the auto mode review needs it’s on page. I’ve been with Medtronic and on an insulin pump since 1997, 20 years! For most of the 20 years, the insulin pump has looked the exact same. It has “mainly” had the same features and not a lot of technology advancements. This new pump, however, is completely different than anything Medtronic has released in the last 20 years, with one caveat that they did release the Minimed 630G a few months prior. I received the Minimed 630G as part of the Minimed 670G Priority Access Group. In case you weren’t aware, Medtronic released a new pump, the 630G, last year and a few weeks (or months, not positive on the timing), the FDA approved their 670G pump faster than they realized. To not waste all the millions of dollars they probably spent on the 630G, they started a Priority Access Group for the 670G where you had to get the 630G first and then once the 670G was released, you could be the first to get it. The stars aligned for me where my pump went out of warranty last year and I had reached my out of pocket max because of the birth of my baby, so I was able to get the 630G for free! I never did use the 630G though because the new design of the pump sort of scared me and I was happy with my old pump. Because I never used the 630G, Continue reading >>
Press Release | Newsroom | Medtronic | Medtronic Initiates U.s. Launch Of World's First Hybrid Closed Loop System For Type 1 Diabetes
Medtronic Initiates U.S. Launch of World's First Hybrid Closed Loop System for Type 1 Diabetes The MiniMed(TM) 670G System Features the Company's Most Advanced SmartGuard(TM)HCL Technology and New Guardian(TM) Sensor 3 DUBLIN - June 7, 2017 - Medtronic plc (NYSE:MDT), today announced the U.S. launch of the MiniMed(TM) 670G system - the world's first Hybrid Closed Loopsystem for people with type 1 diabetes. Featuring the company's most advanced SmartGuard(TM) HCL technology and Guardian(TM) Sensor 3, it is the only insulin pump approved by the Food and Drug Administration (FDA) that enables personalized and automated delivery of basal insulin, the background insulin needed to maintain stable blood sugar levels throughout the day and night. The advanced SmartGuard HCL algorithm works in conjunction with the company's most accurate sensor to date - Guardian Sensor 3 - to self-adjust basal insulin delivery every five minutes based on real-time needs. Through this personalized design, the system is able to maximize Time in Range - the amount of time sugar levels stay within a range considered healthy by clinical standards.The system also exclusively features the CONTOURNEXT LINK 2.4 blood glucose monitoring system (BGMS) from Ascensia Diabetes Care. "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," said Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic. "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 i Continue reading >>
Important Update On Minimed 670g Availability And The Priority Access Program
Last fall we announced the FDA approval of the world’s first hybrid closed loop system and it was one of the proudest days of my career. After 35 years of innovation, we’re thrilled to make this revolutionary technology a reality. The MiniMed 670G® system is the most advanced insulin pump and sensor system that is personalized to your life and your diabetes. The response from the diabetes community has been incredibly touching and we thank you for all of your feedback along the way. Over the last few months we’ve been preparing our manufacturing, training and education – key steps to bringing the product to market. We know that anticipation for the new system is incredibly high and have been working as quickly as possible. But we also take our responsibility as an innovation leader seriously and are committed to taking the time needed to ensure that everyone has the best possible experience on this new system. Today we’re here to share an important update on the rollout of the MiniMed 670G system. Priority Access Program Those who purchased the MiniMed 630G system between August 10th of 2016 and April 28 of 2017 may be eligible to participate in the Priority Access program. These people have the opportunity to be among the first in line to upgrade to the MiniMed 670G system. The reason is that we believe those already using our newest pump platform will experience the easiest and quickest transition to the new system. First Step: The Customer Training Phase As we prepare to make the MiniMed 670G system available to everyone, we’ll start out with a small group of Priority Access program participants at a select number of people with diabetes and healthcare provider sites. This Customer Training Phase will allow us to validate the training and onboarding prog Continue reading >>
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 >>
Medtronic Begins To Roll Out State-of-the-art Insulin Pump
Two Minnesota teens with type 1 diabetes are some of the first patients in the nation to start using Medtronic's new insulin pump, a first-of-its-kind machine that can predict when a person will have a diabetic emergency and automatically adjust insulin levels to prevent it. Allison Scholl, 16, of Edina, and Eleanor Hedlund, 17, of Minneapolis, recently received their new Medtronic MiniMed 670G insulin pumps after using a similar but less-advanced Medtronic pump known as the 630G. Their new 670G units were officially activated on Wednesday in a manual mode, but both teens said they were eager to switch the devices into "auto mode" next week. "I'm a pretty avid endurance athlete. And it's obviously pretty hard to try and control blood sugar when you are constantly working out or being active," Hedlund said Wednesday after receiving training on how to use the device at Park Nicollet's International Diabetes Center in St. Louis Park. "I'm hoping that it will make me able to train more, or not have to drop out of practice. ... Hard workouts are hard to do when your blood sugar is out of whack." Scholl, meanwhile, was a longtime user of a different company's insulin pump. She said she switched brands last fall after Medtronic announced a "Priority Access" program that allowed people who purchase a 630G system to be "first in line" when the newer 670G is available commercially, which happened this week. Medtronic is hoping other type 1 diabetics will follow Scholl's lead and get in line for the 670G. Company CEO Omar Ishrak said in an earnings call with investors in February that Medtronic diabetes-device sales may slow during the quarter ending in April, as patients postponed purchases in anticipation of the 670G. But Ishrak also reiterated that Medtronic's diabetes business Continue reading >>
The Fda Approves Medtronic’s Minimed 670g Hybrid Closed Loop System
By Ava Runge and Adam Brown Coming to US in Spring 2017: What it is, what it isn’t, and how to get it In earlier-than-expected and very good news for people with diabetes, the Food and Drug Administration (FDA) approved Medtronic’s MiniMed 670G hybrid closed loop insulin pump and more accurate Guardian continuous glucose monitoring (CGM) sensor, Guardian Sensor 3. This news represents a major milestone for diabetes technology a little over a decade after JDRF launched the “artificial pancreas” project in 2005. It can’t be emphasized enough how exciting this development is for anyone who takes insulin and has access, since it’s definitely one step closer to the long-term goal of the artificial pancreas – the “ultimate” closed loop. Based on study results, the 670G will reduce time at dangerous high and low blood sugar levels, improve time-in-range, reduce glucose variability, bring much greater nighttime safety and target morning blood sugars, and reduce diabetes hassle. The 670G is not a “cure” and still requires some user effort (see below), but it is a very welcome advance that will make insulin therapy safer and easier for many people with diabetes – and potentially greatly improve their control. The 670G will launch in spring 2017 in the US, bringing the first system to automate basal insulin delivery to market – increasing insulin delivery when glucose is going high and decreasing insulin delivery when glucose is going low. Users still have to bolus for meals, but the system automates basal insulin delivery and targets a set blood glucose of 120 mg/dl, which is particularly effective for improving overnight blood sugars and reducing lows. The MiniMed 670G is FDA approved for people with type 1 diabetes ages 14 and over, though a pediatric Continue reading >>
Medtronic’s Minimed 670g Hybrid Closed Loop Insulin Delivery System Now Available In U.s.
Medtronic, having received FDA approval last year, is now introducing its MiniMed 670G hybrid closed loop insulin delivery system to the U.S. market. The first such system to become available, the MiniMed 670G utilizes Medtronic’s SmartGuard HCL algorithm to deduce when and how much insulin to deliver, yet allowing the patients themselves to make changes when necessary. The system’s most automated setting has it manage insulin delivery as long as the patient inputs carb counts after every meal, confirms any bolus changes, and periodically calibrates the sensor against a conventional finger prick glucometer, the CONTOUR NEXT LINK 2.4 from Ascensia Diabetes Care that comes with the system. The Guardian Sensor 3 within the package that measures glucose levels every five minutes can be worn continuously for up to a week, including during showering and other activities. It has a self-check feature that automatically helps keep the sensor accurate from measurement to measurement, helping to guarantee quality readings and therefore correct insulin delivery. From Medtronic: Data from the pivotal trial of the MiniMed 670G system published in the Journal of the American Medical Association (JAMA) demonstrated less glycemic variability, more time in the target range, less exposure to hypoglycemia and hyperglycemia, and reduced A1c for patients on the system.1 Importantly, real-world use of the system in the Customer Training Phase has shown consistent improved outcomes across several important areas including Time in Range (74 percent) and greater median time in Auto Mode (92 percent).2 Real-world use of the Guardian Sensor 3 also demonstrates continued strong performance and reliability of the company’s most accurate sensor to date with a MARD of 10.56 percent against BG3 Continue reading >>
Medtronic Launches Minimed 670g To Better Manage Diabetes
Medtronic plc MDT commercially launched MiniMed 670G system, a Hybrid Closed Loop insulin delivery system for Type I diabetic patients. This happened following the U.S. FDA approval late last year. MiniMed 670G should help Medtronic simplify and improve diabetes management through advancement of smart algorithms that helps control glucose levels in diabetic patients. The MiniMed 670G system features Medtronic's its latest Guardian Sensor 3 - a glucose sensor with increased accuracy and enhanced performance. This is the only FDA approved sensor to control a hybrid closed loop system which includes diagnostic technology that continuously checks sensor health. The system also carries Medtronic's most advanced algorithm known as SmartGuard HCL technology. Incidentally, this system with latest algorithm can capture data related to a patient's insulin needs, requiring minimal input to minimize both high and low glucose levels. Patients only need to enter mealtime carbohydrates, accept bolus correction recommendations and at times, regulate the sensor. Hopes are harboured about the effectiveness of this system which should get greater customer adoptability over time. Notably, MiniMed 670G had got earlier-than-expected approval from the U.S. FDA, following just 104 days of Pre-Market Approval (PMA) application filing. Taking into consideration the huge growth potential of global diabetes care market, we believe Medtronic's focus to expand is perfectly strategic. Per Markets and Markets report, the global diabetes care device market has been forecast to reach $2.3 billion by 2020 and is estimated to grow at a CAGR of 6.3%, during the forecast period. Price Performance The company has been observed to underperform the Zacks categorized Medical - Products industry since last month Continue reading >>
World’s First Hybrid Closed-loop System To Hit The Market This Year
The device is called MiniMed 670G. It was developed by Medtronic (NYSE:MDT) and is referred to as a ‘hybrid closed-loop system’. It works by monitoring blood sugar – measuring it every 5 minutes (via an automated glucose monitor), then delivers the needed amount of insulin (using its own insulin pump and needle) based on the readings. It’s also designed to automatically withhold the release of insulin as soon as it detects a decrease in sugar levels. With these complementary functions, the risk of getting either excessive or inadequate amounts of insulin is minimized. As great as this device sounds, it’s not yet perfect. Although the part about insulin monitoring and correct insulin dosage is already accounted for, there’s still the matter of calibrating the sensors every 12 hours to make sure that they are working optimally. The glucose sensors also have to be replaced once a week, while the insulin reservoir needs refilling every 3 days. According to Medtronic, MiniMed 670G is set to be commercially available come spring season. Right now, the device can only be used by patients aged 14 and higher — the restriction set by the FDA approval. But Medtronic isn’t stopping there. They are currently conducting clinical trials on younger patients. If tests become successful as hoped, the device may eventually become available to all diabetes-1 patients, regardless of their age. Based on statistics from the American Diabetes Association, approximately 1.25 million Americans are suffering from diabetes-1, an autoimmune disease that usually develops during childhood and is characterized by the body’s immune system attacking and destroying insulin-producing cells in the pancreas, to the point that the person’s pancreas stops producing insulin altogether. Insu Continue reading >>
Medtronic Announces Us Launch Of Minimed 670g Hybrid Closed-loop System
Medical device company Medtronic has announced the US launch of the 'world's first' hybrid closed-loop system, a near-artificial pancreas, for people with type 1 diabetes. Medtronic's MiniMed 670G system, which self-adjusts blood sugar levels and delivers basal insulin when needed, has been given the go ahead by the US Food and Drug Administration (FDA). Alejandro Galindo, president of the Intensive Insulin Management division within the Diabetes Group at Medtronic, said: "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." The pioneering MiniMed 670G has been vigorously tested. Research published in the Journal of American Medical Association (JAMA) last year showed the device led to less variation in blood sugar levels and fewer episodes of hypoglycemia and hyperglycemia in people with diabetes aged 14 or older. ""We've essentially designed a smarter insulin pump that alleviates some of the burden associated with diabetes management, which can be unrelenting and exhausting," said Galindo. The hybrid closed-loop system comprises the use of the Medtronic MiniMed 670G insulin pump, fourth-generation sensors and a control algorithm to determine basal insulin delivery. This system helps to keep blood glucose levels within normal ranges by measuring levels every five minutes and automatically responding by administering or withholding insulin. Dr Jennifer Lynn Sherr, assistant professor of endocrinology at the Yale School of Medicine, said: "The MiniMed 670G system has proven to be life-changing for many patients [...] and we are truly excited to be able to introduce it to many more who stand to benefit. "We've seen this s Continue reading >>
Where Is The Minimed 670g System?
We are all eagerly awaiting the release of the new MiniMed 670G closed loop system for us diabetics. It was approved by the FDA in September 2016 and MiniMed said it would be released in the spring of 2017… Well, it’s now spring 2017 and there’s been no release date yet. I know I seem very impatient but I’m sure all of us diabetics are extremely impatient!!! Today we will call MiniMed and try to get an update on the MiniMed 670G system release date. We’ll keep you all informed on here. Continue reading >>
Minimed 670g System Launches In The United States
I am pleased to share that today we announced the commercial launch of the MiniMed 670G system. Since earlier- than-expected FDA approval in September 2016, we have been working to ensure payer coverage, market and manufacturing readiness, as well as appropriate training of employees, clinicians, educators and patients on the new system. We also initiated our Customer Training Phase, which validated our robust training and onboarding program among a small group of Priority Access Program participants. This initial rollout allowed us the opportunity to review our protocols and ensure an optimal experience for those transitioning to the new system. Real-world use of the system in the Customer Training Phase has demonstrated improved outcomes across several important areas including greater Time in Range (74 percent) and greater median time in Auto Mode (92 percent).1 Real-world use of the Guardian Sensor 3 also demonstrates continued strong performance and reliability of the company’s most accurate sensor to date with a MARD of 10.56 percent against BG2 – confirming why it’s the only continuous glucose monitor trusted and approved by the FDA to power a hybrid closed loop system. Following excellent feedback on system performance, clinical outcomes and user experience in the Customer Training Phase – including a 94 percent overall satisfaction rate with the training and onboarding – the company has made the decision to initiate a broader commercial launch. Medtronic is now onboarding the rest of those enrolled in the Priority Access Program who signed up to be first in line to receive the system upon commercial launch. In parallel, we are now taking new orders from interested customers who want to be next in line to receive the system after Priority Access orders Continue reading >>
Who'll Be The First To Meld With The Machines? Diabetics
Tia Geri is the shortest player on her club soccer team. But that doesn’t stop her teammates from looking up to her. Geri, who turned 17 last month, has been playing with the same group of girls for almost as long as she’s been living with type 1 diabetes. And while she’s not the only one on the team with the disease, she is the only one with an artificial pancreas—a computer system that can control her insulin levels without her telling it to. A sensor on her abdomen monitors the glucose in her blood, and a pump adds the insulin her body needs to turn that sugar into energy. Geri is one of the first people in the country to get the MiniMed 670G, the first bionic pancreas to be approved by the US Food and Drug Administration. She's been wearing hers since the fall of 2015, when she enrolled in the clinical trial that would eventually win the partially autonomous device regulatory approval. During a recent Monday night practice in Palo Alto, California, a teammate named Caroline watched Geri chase a soccer ball around a game of keep-away, while checking her own glucose meter and sipping a Capri Sun from the sidelines. “Tia’s so lucky,” she said. “I can’t wait until I get mine.” Caroline and the rest of America's type 1 diabetics don’t have much longer to wait. Medtronic, the Minneapolis-based company that makes the device, is currently taking pre-orders it will ship to patients starting this June. And while the MiniMed 670G is not a technological cure for diabetes—patients still have to program in their meals, adjust their blood sugar targets when they want to exercise, and change out the sensor every week—it's a milestone for machine-mediated disease management. Five years ago it wasn’t obvious the feds would ever be comfortable letting a com 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 >>
Fda Approves First "artificial Pancreas" For Type 1 Diabetes
The U.S. Food and Drug Administration on Wednesday approved the first automated insulin delivery system -- a so-called “artificial pancreas” -- 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. The device -- Medtronic’s MiniMed 670G -- is what’s known as a hybrid closed-loop system. That means it monitors blood sugar and then delivers necessary background (also known as basal) insulin doses. The device will also shut off when blood sugar levels drop too low. However, this device isn’t yet a fully automated artificial pancreas. People with type 1 diabetes will still need to figure out how many carbohydrates are in their food, and enter that information into the system, the agency noted. Medtronic said the new device will be available by Spring 2017. The FDA approval is currently only for people aged 14 and older. The company is now conducting clinical trials with the device in younger patients. Type 1 diabetes is an autoimmune disease caused by a mistaken attack on healthy insulin-producing cells in the body, destroying them. Insulin is a hormone necessary for ushering sugar into cells in the body and brain to provide fuel for the cells. People with type 1 must replace the insulin their bodies no longer produce, through multiple daily injections or through a tiny catheter attached to an insulin pump. However, figuring out exactly how much insulin to give is no easy task. Both too much and too little insulin can have dangerous, even deadly conseq Continue reading >>
