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A Diabetic Product Review For Non-diabetics - The Medtronic Minimed Paradigm

A Diabetic Product Review For Non-diabetics - The Medtronic Minimed Paradigm "revel" Insulin Pump And Cgm

Sponsored By This is a review for Diabetics. If you're not a diabetic, consider this and it might help you enjoy this review. This is a product that will never affect your life. You've probably not thought about how an insulin pump works or its features. Here's a nice analogy I use to explain how diabetes works. It's called Diabetes: The Airplane Analogy. I've just received an upgrade to my insulin pump and I'm thrilled. Products like this are as important to us (diabetics) as your phone, your fancy remote control, your new DVD Player. I touch this device as often as my phone. It's attached to me 24 hours a day, it's an "external organ" to me. I've worn an insulin pump every day, all day (except showers) for the last decade. If you find this interesting, please consider helping fight diabetes: or tweeting the link I've had Medtronic pumps since 2000. I upgraded to a Paradigm with a CGM "Continuous Glucose Meter" in 2006. Last week I upgraded to a new Paradigm "Revel" Insulin Pump with a number of new features. Insulin Pumps have come a long way since they were backpacks. If you're not familiar, here's some diabetic equipment basics. Diabetes Basics I'm a Type 1 Diabetic. That means my body produces no insulin of its own and I need to get insulin from outside sources. When I eat food, the sugar in my blood goes up and isn't delivered to my cells and my body starves while marinating it its own sugar. When I take insulin, my cells unlock, sugar (fuel) is delivered to the cells, and my blood sugar values go down. Eat, go up, take insulin, go down. What's a Blood Sugar Meter do? It does just that, it measures the level of sugar in my blood. I prick my finger, usually 10 times a day or so, and I put the drop of blood on a small gauze strip that goes into a machine and gives m 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 >>

Trial Results Published For Medtronic's Minimed 670g

Trial Results Published For Medtronic's Minimed 670g

Results show how the hybrid closed loop system reduced glycemic variability, which leads to fewer long-term complications from type 1 disease. Results from a pivotal trial for the Medtronic MiniMed 670G, the first hybrid closed-loop insulin delivery system, have been published in Diabetes Technology & Therapeutics, more than 4 months after the FDA approved the device. Touted by JDRF as the world’s first “artificial pancreas,” the MiniMed 670G will be available this spring, according to statements from Medtronic. The trial reports what had been announced already: the hybrid closed-loop (HCL) system was safe for home use, giving users increased time in their target range, with reductions in glycated hemoglobin (A1C) and less hypoglycemia or hyperglycemia than patients had at baseline. Notably, there were no severe events of hypoglycemia or any diabetic ketoacidosis in either patient group. The trial involved 30 adolescents, which included those 14 to 21 years of age, and 94 adults, 22 to 75 years of age, all with type 1 diabetes (T1D). Ten sites, 9 in the United States and 1 in Israel, took part in the pivotal trial. Adults had an average age of 44.6 years and had lived with T1D and average of 26.4 years. Adolescents averaged 16.5 years old and had lived with T1D an average 7.7 years. According to the article, participants were trained on how to use the MiniMed 670G and related supplies, and they uploaded their blood glucose data using the system’s customized software every day for 2 weeks before turning on the device. After that, they uploaded data weekly. Of the 129 patients in the trial, only 4 withdrew, including 3 before the run-in phase was finished. Patients used the devices for 3 months after that. The HCL system was used for 12,389 patient days (2977 for Continue reading >>

Medtronic Minimed Insulin Pump Lawsuits

Medtronic Minimed Insulin Pump Lawsuits

On November 18, 2017, the FDA announced a Class 2 device recall for over 9.5 million Medtronic MimiMed Infusion sets. A Class II recall is an immediate threat level recall, and identifies products that might cause a temporary health problem. The recall covers the MiniMed Sure-T, Mio, Silhouette, and Quick-Set Infusion Sets manufactured prior to April 2017. Medtronic MiniMed infusion sets used with non-Medtronic pumps and those without tubing are not covered by this recall. The recalled devices have the potential to over-deliver insulin to patients with diabetes, which can lead to hypoglycemia. Symptoms include anxiety, confusion, cold sweats, trembling, fatigue, hunger, and irritability. In extreme cases, hypoglycemia can cause seizures, coma, and even death. The company began informing patients and doctors about the recall in September 2017, noting that patient reports linked certain lots of the infusion sets to problems that could result in over-delivery of insulin. They advised consumers to check the companys website for information on lot numbers to see if they were using a recalled one of the products. Patients who have suffered serious injuries because of this or other issues with Medtronic insulin pumps and infusion sets may be eligible to file lawsuits in an attempt to recover damages. Some lawsuits have already been filed against the company. Chaffin Luhana is actively investigating whether other patients were hurt. What is a Medtronic MiniMed Insulin Pump? Patients with type 1 diabetes produce little or none of the hormone insulin, which helps the body process glucose from fuel. Without insulin, the bodys cells cant draw energy from food. The glucose then builds up in the bloodstream, which can cause high blood pressure and lead to other health problems. Pati Continue reading >>

Medtronic Warns Of Stuck Minimed Pump Buttons

Medtronic Warns Of Stuck Minimed Pump Buttons

Changes in air pressure might cause an issue, the pump maker warns. Stuck insulin pump button on a plane! … sounds like a straight-to-video Samuel L. Jackson thriller, but it’s actually the gist of a safety notice issued by Medtronic for those who use its MiniMed pump systems. sponsor Medtronic issued a field safety notification about a rare, temporary, but still annoying glitch that can happen with MiniMed 600 series pumps. When atmospheric pressure around the pump increases or decreases rapidly, it can cause the keypads on the pumps to become stuck or difficult to push down. The notice states that if the button seems difficult to push down, it’s most likely a temporary situation which will usually resolve itself within 30 minutes. The bigger problem is when the pump button gets stuck in a pressed position. The pumps are designed to cut off insulin delivery (both bolus and basal) within three minutes of detecting such a problem, but this can cause a siren to go off if the situation isn’t resolved within 10 minutes, and insulin delivery won’t resume until you clear the alarm. To solve this, they suggest the elegantly low-tech solution of removing the pump’s battery cap and then installing it again. They warn, however, that you might need to have a AA battery handy, as the pump might decide then that it needs a new one. Medtronic is currently not suggesting that MiniMed pumps need to be recalled or repaired because of this issue. The Medtronic MiniMed 600 series includes the 630G, the 640G, and the 670G. Customers should already have received notice of this issue from Medtronic. This isn’t the first reported issue to arise with the MiniMed pump systems. Earlier this year, Medtronic warned that kinked cannulas could cause insulin delivery interruption in Min Continue reading >>

Fda Approves First

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 >>

Medtronic Launches Minimed 670g To Better Manage Diabetes

Medtronic Launches Minimed 670g To Better Manage Diabetes

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. The company has been observed to underperform the Zacks categorized Med Continue reading >>

The Latest News On Medtronic Minimed 670g

The Latest News On Medtronic Minimed 670g

Paradigm: The name for a generation of Minimed pumps that began with the 512 pump in 2003 and carried on through mostly 2013. Revel: This name was tacked on to the Minimed pumps in 2010 and was used up until 2013 when the next-generation Minimed 530G was launched. Guardian: Medtronic’s first CGM generation dating back to 2004, with the release of the stand-alone Guardian Real-Time system CGM. The Guardian name wasn’t used much after 2010 -- until now, with the fourth-generation CGM sensor they're calling the Guardian 3. Medtronic is reportedly planning for to launch a Guardian Mobile next generation stand-alone CGM in late 2016 or in 2017. Enlite: The Enlite CGM name came on the scene in Europe in 2011 and has remained the name of the CGM sensor since, though in the U.S. the latest pre-Enlite sensor was known as the Sof-Sensor. Internationally, the company’s third-generation sensor is known as Enhanced Enlite/Enlite 2, and followed by that was supposed to be the fourth-generation sensor called Enlite 3 -- the name used in research prior to approval. Harmony 1: This is the planned name for Medtronic’s fifth-generation sensor, according to research presented at the ADA Scientific Sessions in June 2016. This is expected to be a 10-day wear, with increased accuracy and built-in Bluetooth in order to communicate with a BT-enabled pump device and a smartphone. This still in the R&D phase and no timeline has been communicated yet. Minimed Connect and CareLink: CareLink is the company's data software, and Connect is the newer data connectivity platform for Medtronic devices. Connect is an app-based product that shares data to the cloud and allows patients to see their data on smartphones (currently only iPhones, though Android's in the works). Unfortunately, newest MedT Continue reading >>

How Dexcom Can Fight Back Against Medtronic's Artificial Pancreas

How Dexcom Can Fight Back Against Medtronic's Artificial Pancreas

Medtronic plc (NYSE:MDT) got an FDA green-light last week to begin marketing its artificial pancreas, the MiniMed 670G, and management is planning to launch the device early next year. Will the 670G dent demand for DexCom's (NASDAQ:DXCM) continuous glucose monitors in 2017? Read on to find out how DexCom plans to keep growing. A game-changing innovation Insulin is a hormone produced in the pancreas that is used to break down sugar into energy. However, in 1.25 million Americans who are diagnosed with type 1 diabetes, the pancreas fails to produce insulin, forcing patients to monitor their blood sugar levels and dose themselves insulin as necessary. The burden associated with managing type 1 diabetes is heavy, and as a result, most diabetics' blood sugar levels are out of the desired range most of the time. That's worrisome because blood sugar highs and lows can lead to life-threatening illnesses, such as heart disease. To reduce the risk of blood sugar highs and lows, Medtronic developed the 670G, a system that uses a blood glucose sensor, an insulin pump, and an infusion patch to automatically keep a type 1 diabetes patient's blood sugar levels on target. Once patients program their information into the device, the 670G manages insulin levels by automatically checking blood sugar every five minutes and dosing insulin at the appropriate levels when needed. Mealtime insulin doses are automatically calculated based on each patient's programmed insulin to carbohydrate ratio and the amount of carbohydrates that will be eaten. Upcoming threat Until now, DexCom's continuous glucose monitors (CGM) have been the biggest advance in type 1 diabetes treatment. The company's latest-generation CGM, the G5, automatically streams blood glucose levels to a patient's device or smartphon Continue reading >>

Minimed Connect And Nightscout

Minimed Connect And Nightscout

Set up MiniMed Connect with Nightscout on Azure This setup guide will enable you to bridge data from the MiniMed Connect into a Nightscout site running on Azure. If you use a Medtronic Enlite CGM, you will be able to view the numbers and trends from the CGM in Nightscout. If you use a Medtronic insulin pump compatible with the Connect, you will be able to pump status data such as active insulin in Nightscout. NOTE: You will not be able to see the amounts of specific boluses or glucose values from linked meters. This bridge can only see the data which is visible in CareLink Connect. You should already have: a MiniMed Connect and compatible pump an iPhone running the MiniMed Connect app a username and password for CareLink You should already be able to: see real-time values from the Connect (sensor glucose, active insulin, etc.) in the iPhone app log into CareLink on your web browser using your username and password, go to the CareLink Connect section, and see the same values If you haven’t achieved the above, read the online help or contact Medtronic support. Note: If you already have a Nightscout site, you may skip this step. Instead, use the Nightscout Update Fork Tool to ensure that your site is running the latest version of Nightscout. Follow all the steps in the Nightscout with iOS and Dexcom Share Bridge setup guide except step 4. Set aside a decent amount of time to get through it. We can use this guide because the MiniMed Connect plugin works very similarly to the Dexcom Share Bridge plugin, except instead of reading data sent to Dexcom’s servers by the Dexcom Share app, it reads data sent to Medtronic’s servers by the MiniMed Connect app. If you need more help or need to troubleshoot a step of this process, the main Nightscout setup guide walks through eac Continue reading >>

Fda Approves Medtronic's 'artificial Pancreas' For Diabetes

Fda Approves Medtronic's 'artificial Pancreas' For Diabetes

Medtronic Plc won U.S. approval on Wednesday for an "artificial pancreas" that is the first device to automatically deliver the right dose of insulin to patients with type 1 diabetes, freeing them from continually monitoring insulin levels throughout each day. The U.S. Food and Drug Administration, in its approval of the device, the MiniMed 670G, hailed it as a breakthrough. The device offers type 1 diabetics "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 medical device division, said in a statement. Analysts said the FDA approved the device six months sooner than expected. However, it will not be available until the spring of 2017. The MiniMed 670G is the first device that allows a glucose sensor to communicate with an insulin pump and automatically regulate the insulin flow. The device is approved for those aged 14 and older. The device measures glucose levels every five minutes and automatically administers insulin as needed. Patients will still need to instruct the device to deliver extra insulin for meals and notify the device when they exercise - which lowers glucose levels. About 1.25 million American children and adults have type 1 diabetes, a condition in which the pancreas produces little or no insulin - a hormone needed to obtain energy from food. Patients take insulin injections at various times of the day. But blood sugar can drop to dangerously low levels if too much insulin circulates in the bloodstream, requiring patients to frequently or continually monitor their insulin levels throughout the entire day. "This device will mean peace of mind, in knowing a person will be in normal blood sugar range a great majority of the ti Continue reading >>

670g And Me: Insights And Incites On Medtronic’s Latest System

670g And Me: Insights And Incites On Medtronic’s Latest System

What’s the purpose of a diabetes management device? Is it to lower A1c? Prevent hypoglycemia? Spend more time in-range? Some combination of all three? Or perhaps we have to look beyond blood sugar control. After all, quality of life has to count for something. Does it make living with diabetes safer and easier? My Detailed Review of The MiniMed 670G from Medtronic The MiniMed 670G from Medtronic is an insulin pump coupled with a glucose sensor. It uses a computer program (called an “algorithm”) to automate certain aspects of insulin delivery. I decided to try 670G partially out of professional interest (everybody and their great aunt has been asking for my opinion on the system), and partially out of personal interest, as my blood glucose control hasn’t been the greatest the past couple of years. Let me start out by saying this: Since I started using 670G, my overall blood glucose control is better. I have to keep reminding myself of this non-consequential fact, because every day I find things about this system that I don’t particularly like. In my opinion, the pump itself leaves a lot to be desired. There are so many features and so many menus and so many safety/confirmation steps that my button thumb is starting to form a blister. The color screen is nice, but not large enough to display everything it needs to display. And the freakin’ clip is upside down. The reservoir connector pokes me in the gut every time I bend over, and I have to unclip it to see the screen and programming menus in the proper orientation. The “hybrid closed loop” part of the system (what I prefer to call the “semi-automatic feature”) is what makes 670G special. It functions by making adjustments to the BASAL insulin based on data received from the linked glucose sensor. Sinc Continue reading >>

Insulin Pump Rundown

Insulin Pump Rundown

Choosing an insulin pump doesn’t have to be an overwhelming process. Should you go with a more traditional pump where you can monitor your insulin levels directly? Are you looking for a model that works with a BGM monitor and allows you to administer insulin via a remote? Maybe you need a pump that offers integration with a CGM system. What about size? Color? To use tubes or not to use tubes? Presenting the options so you can find out what pump best fits your lifestyle is our goal. So, with several models on the market, let us help you sort through the choices by taking a look at what’s available and breaking down the various features of each. We’ve separated the pumps into four categories: pumps that incorporate or work with a Blood Glucose Monitor (BGM) and offer Continuous Glucose Monitoring (CGM), pumps with just CGM capability, pumps with just a BGM, and standalone pumps that don’t work with a BGM or offer CGM. Hybrid Closed-Loop System The 670 G system is the newest member to the Medtronic pump family and the first hybrid closed-loop system. In other ways, it is a like a “basal modulator” where you have to still bolus but it predicts your basal rate. Every 5 minutes, the auto-mode option (hybrid closed-loop) automatically adjusts basal insulin delivery based on your sugar levels to keep you range. It is excellent at catching lows because it stops your insulin dosage 30 minutes before you reach your pre-selected low limits, then it will automatically restart insulin when your levels recover. Possible concerns: excessive alerts and extended menu that needs clearing. Only approved for ages 14+ because it has a total daily dose requirement of at least 8 units a day. Feeling of loss of control of management with closed-loop system. Pumps with BGM and CGM ca Continue reading >>

Meet The Minimed™ 630g System

Meet The Minimed™ 630g System

PREDICTIVE ALERTS The pump lets you know up to 30 minutes ahead if you’re trending high or low, so you can act sooner to keep your glucose levels where you want them. Continuous Glucose Monitoring (CGM) The sensor wirelessly sends glucose information to your pump every five minutes, so you can see how you’re doing, spot trends and make adjustments. * CGM uses a special sensor to measure sugar levels just below the skin known as interstitial fluid. These sensor glucose (SG) values are different from blood glucose (BG) measurements using a BG meter. Sensor glucose values should not be used to make treatment decisions. Patients should always do a BG fingerstick before they make treatment decisions. ** The Bolus Wizard calculator does not account for manual injections and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard calculator. OTHER BENEFITS OF THE MINIMED 630G INSULIN PUMP § The MiniMed™ 630G insulin pump is waterproof in up to 3.6 meters (12 feet) of water for up to 24 hours. The Guardian™ Link transmitter is waterproof in up to 2.4 meters (8 feet) of water for up to 30 minutes. See product user guide for care instructions to help maintain waterproof. EXCLUSIVE SMARTGUARD TECHNOLOGY FOR BETTER GLUCOSE CONTROL Insulin pump technology with SmartGuard technology makes it easier to stay in range. You’re four times more likely to reach your target A1C and you can also reduce low glucose episodes by up to 84 percent and lower the risk of long-term complications.1, 2 1. Bode BW, Steed RD, Davidson PC. Reduction in severe hypoglycemia with long-term Continue reading >>

Medtronic Announces Us Launch Of Minimed 670g Hybrid Closed-loop System

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 >>

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