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Fda Approved Insulin Pumps

Fda Approves Tandems T:slim X2 Pump For Use With Dexcom G5 Mobile Cgm

Fda Approves Tandems T:slim X2 Pump For Use With Dexcom G5 Mobile Cgm

FDA Approves Tandems T:Slim X2 Pump for Use With Dexcom G5 Mobile CGM Tandem Diabetes Care, the maker of the t:Slim X2 insulin pump has been FDA approved for integrated use with the Dexcom G5 Mobile continuous glucose monitor (CGM) making it the first CGM enabled pump approved to let users make treatment decisions without first pricking their finger. Tandem makes the only touchscreen insulin pumps in the US and now users of the t:slim X2 pump can do a free remote software update for CGM integration using their pump or personal computer. If youre a t:slim X2 user, lookout for an email being sent to you with instructions on how to do the update. According to a Business Wire press release , the t:slim X2 pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and up. The t:slim X2 pump is the only pump on the market that offers remote software updates, it is 38 percent smaller than other pumps, has a large color touchscreen, Bluetooth radio, rechargeable battery, USB connectivity, and a 300-unit insulin capacity and watertight construction. It is the only pump right now that shows insulin delivery activity on its screen and Dexcom G5 Mobile CGM data at the same time on one device. Kim Blickenstaff, the President and CEO of Tandem Diabetes Care, said at the press release, We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump, and explained that The t:slim X2 Pump is designed to accelerate the pace in which we can bring new innovations to people with diabetes, which is of particular importance as we develop software updates to add automated insulin delivery algorithms to our platform. Whats Unique About Dexcoms G5 Mobile Continue reading >>

Abbott Wins Fda Approval For Diabetes Device That Doesn't Require Routine Finger Pricks

Abbott Wins Fda Approval For Diabetes Device That Doesn't Require Routine Finger Pricks

The U.S. Food and Drug Administration approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries. Abbott Laboratories has gained clearance to start selling in the U.S. the first continuous glucose monitor that does not require people with diabetes to routinely prick their fingers. The U.S. Food and Drug Administration on Wednesday approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System for adults, which already is sold in 41 other countries. The device consists of a small sensor, about the size of a quarter, that’s worn on the back of the upper arm to continuously track glucose levels. The sensor, unlike other wearable sensors, does not require patients to prick their fingers for calibration. Patients can place a hand-held reader near the device to see their current glucose levels, trends, patterns and where those levels might be headed. They can then use those readings to figure out how much insulin to take to manage their diabetes. The device has not yet been approved for use by children in the U.S. but Abbott hopes to gain approval from the FDA. The company is not disclosing pricing information until it gets closer to launching the product in the U.S., which will likely be before the end of the year, said Abbott spokeswoman Vicky Assardo. But she said in an email the price will be “very similar” to the price in Europe, where the reader costs about $69, and each sensor, which lasts about 14 days, also costs about $69, before insurance. In the U.S., the sensor will last about 10 days. “We intentionally designed the product to make it as affordable as possible,” said Jared Watkin, Abbott senior vice president of diabetes care. In the U.S., continuous glucose monitors are often covered Continue reading >>

The Artificial Pancreas Device System

The Artificial Pancreas Device System

FDA's Efforts to Advance Artificial Pancreas Device Systems The FDA supports and fosters medical device innovation as it upholds its mission of ensuring that medical devices are safe and effective. The FDA is helping advance the development of an artificial pancreas device system, an innovative device that automatically monitors blood glucose and provides appropriate insulin doses in people with diabetes who use insulin. Sometimes an artificial pancreas device system is referred to as a "closed-loop" system, an "automated insulin delivery" system, or an "autonomous system for glycemic control." NOTE: The Artificial Pancreas Device Systems described on this site do not involve biomaterial, synthetic or artificial tissue or organs. The FDA has been working together with diabetes patient groups, diabetes care providers, medical device manufactures, and researchers to advance the development of an artificial pancreas. FDA's efforts include prioritizing the review of research protocol studies, providing clear guidelines to industry, setting performance and safety standards, fostering discussions between government and private researchers, sponsoring public forums, and finding ways to shorten study and review time. There have been tremendous strides made in the research and development of an Artificial Pancreas Device System. On September 28, 2016, the FDA approved the first hybrid closed loop system, the Medtronic's MiniMed 670G System, intended to automatically monitor blood sugar and adjust basal insulin doses in people with type 1 diabetes. There are also many research projects underway looking at the feasibility of these device systems in hospital settings. For more information on these and other clinical trials, visit www.clinicaltrials.gov. On this Artificial Pancreas Continue reading >>

Tandem Diabetes Care Announces Fda Approval And Launch Of T:slim X2 Insulin Pump With Dexcom G5 Mobile Cgm Integration

Tandem Diabetes Care Announces Fda Approval And Launch Of T:slim X2 Insulin Pump With Dexcom G5 Mobile Cgm Integration

SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care®, Inc. (NASDAQ: TNDM), a medical device company and manufacturer of the only touchscreen insulin pumps available in the United States, today announced U.S. Food and Drug Administration (FDA) approval and commercial launch of the t:slim X2™ Insulin Pump with Dexcom G5® Mobile continuous glucose monitoring (CGM) integration, the first sensor-augmented insulin pump approved to let users make treatment decisions without pricking their finger1. The software featured on this pump will also be available to current t:slim X2 Pump users at no cost via remote software update, allowing them to add CGM integration to their existing pumps from home using a personal computer. Individual emails are being sent directly to t:slim X2 Pump customers with instructions on how to perform the update. The t:slim X2 Pump with Dexcom G5 Mobile CGM integration is approved for ages 6 and older. “We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump” Tweet this This approval marks the Company’s fifth new insulin pump launch in only 5 years and the second featuring Dexcom technology. It is the only available pump that conveniently displays a user’s insulin delivery activity and Dexcom G5 Mobile CGM data together on a single device. The t:slim X2 Pump is also the only insulin pump capable of remote software updates2, allowing existing users to add features like CGM integration from home. It is up to 38% smaller than other pumps3, but includes advanced features like a large color touchscreen, Bluetooth® radio, rechargeable battery, USB connectivity, 300-unit insulin capacity and watertight construc Continue reading >>

Insulin Pump

Insulin Pump

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

Fda Clears Finger-prick Free Insulin Pump-cgm Combo

Fda Clears Finger-prick Free Insulin Pump-cgm Combo

The FDA has approved the first insulin pump – glucose monitor combination of devices which can recommend treatment decisions without the need for a finger-prick blood test. Tandem Diabetes’ t:slim X2 Insulin Pump has received FDA approval for use alongside Dexcom’s G5 Mobile continuous glucose monitoring (CGM) technology. The approval is part of a rapid evolution in insulin management, with digitisation and automation gathering pace. On its own, the t:slim X2 Insulin Pump is one of the smallest insulin pumps on the market and features the firm’s proprietary Micro-Delivery Technology – a method of minuscule insulin delivery claimed to be safer than traditional insulin pumps. Its touchscreen display shows live blood glucose readings and can alert users when blood glucose rises higher or drops lower than their target range. A trend arrow also gives users an idea of their future blood glucose levels. Meanwhile, the Dexcom G5 Mobile CGM, which uses a small, under-the-skin sensor that measures glucose levels in interstitial fluid, is the only CGM approved for therapeutic use by the FDA, meaning it can be used to inform treatment decisions. The fact that it doesn’t need a finger-prick test once it has been inserted under the skin sets it apart from other CGMs on the market. The newly-approved device will now give both diabetes patients access to insulin pump and Dexcom G5 CGM data in one device. Existing t:slim X2 Pump users will also be given the software upgrade for free, giving them the ability to integrate CGM data. “We are setting a new standard in our industry by simultaneously offering our existing and future customers the benefits of best-in-class CGM integration on our simple-to-use touchscreen insulin pump,” said Kim Blickenstaff, president and CEO of Continue reading >>

Minimed 670g System - P160017/s017

Minimed 670g System - P160017/s017

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for the FDA's approval. Address: 18000 Devonshire Street, Northridge, CA, 91325 What is it? The MiniMed 670G System is a hybrid closed loop system that monitors glucose and automatically adjusts the delivery of long acting or basal insulin based on the user's glucose reading. This device was approved on September 28, 2016 under P160017. The current approval adds a new indication to insert the sensor into the patient's upper arm. How does it work? The MiniMed 670G System consists of a continuous glucose monitor (CGM) that measures the user's glucose levels for up to seven days, an insulin pump that delivers insulin to the user, and a glucose meter used to calibrate the CGM. The MiniMed 670G System is able to decrease or stop insulin delivery when it detects the user's glucose is low, or increase the insulin delivery when the system detects the user's glucose levels are high with no input from the user. The glucose sensor contains a wire that is inserted under the skin on the abdomen or, as approved in this supplement, the upper arm. The glucose sensor measures glucose values in the tissue fluid. The glucose values are wirelessly sent to the insulin pump, and displayed along with glucose trend information, alerts, and alarms on the pump screen. The insulin pump delivers a prescribed dosage of insulin through an infusion set. The insulin pump can automatically adjust the delivery of insulin using a mathematical equation, or algorithm that incorporates information from the CGM. The system has two modes; Ma Continue reading >>

Fda Approves Minimed 670g System – World’s First Hybrid Closed Loop System

Fda Approves Minimed 670g System – World’s First Hybrid Closed Loop System

the first hybrid closed loop system in the world! 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. You may be wondering how this system is different from the MiniMed 630G system we recently launched in the U.S. Advanced SmartGuard Technology The MiniMed 670G system features our most advanced algorithm to date – SmartGuard HCL – which simplifies and improves diabetes management through a smart algorithm that enables greater glucose control with reduced user input. Through SmartGuard HCL, the system builds on Medtronic’s industry leading algorithms to offer therapy customization so people with diabetes and providers can choose from increasing levels of automation that best fit their diabetes management needs. Driven by the SmartGuard HCL, the system delivers a variable rate of insulin 24 hours a day based on the personalized needs of the individual, maximizing the time glucose levels are within the target range. It is designed to learn what an individual’s insulin needs are and to take action to minimize both high and low glucose levels. As a result, the system requires minimal input – users only need to enter mealtime carbohydrates, accept bolus correction recommendations, and periodically calibrate the sensor. New Guardian Sensor The system uses our new Guardian Sensor 3, our most advanced and accurate glucose sensor. The sensor offers seven-day continuous wear and incorporates diagnostic technology that continuously monitors how the sensor is doing, resulting in a CGM system trusted to power the hybrid closed loop system. It is also the first and only sensor approved by the FDA to cont Continue reading >>

Fda Approves First Automated Insulin Delivery Device For Type 1 Diabetes

Fda Approves First Automated Insulin Delivery Device For Type 1 Diabetes

Release The U.S. Food and Drug Administration today approved Medtronic’s MiniMed 670G hybrid closed looped system, the first FDA-approved device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes. The human pancreas naturally supplies a low, continuous rate of insulin, known as basal or background insulin. In patients with diabetes, the body’s ability to produce or respond to insulin is impaired. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases – especially those that require day-to-day maintenance and ongoing attention,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “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.” The MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin; an insulin pump strapped to the body; and an infusion patch connected to the pump with a catheter that delivers insulin. While the device automatically adjusts insulin levels, users need to manually request insulin doses to counter carbohydrate (meal) consumption. According to the U. S. Centers for Disease Control and Prevention, approximately 5 percent of people with diab Continue reading >>

How Will The Fda Approval Of The Artificial Pancreas Change The Lives Of Those Living With Type 1 Diabetes?

How Will The Fda Approval Of The Artificial Pancreas Change The Lives Of Those Living With Type 1 Diabetes?

In case you havent heard the news lately, on September 28th, the Food and Drug Administration in the United States approved the first automated insulin delivery system. Medtronics MiniMed 670G is the first approved device by the FDA that can automatically provide the correct dosing of both bolus and basal inulin based on the blood glucose readings from the continuous glucose monitoring system. This closed loop device is known to many as the Artificial Pancreas and has been approved for people with type 1 diabetes ages 14 years old and older. The pancreas offers a low but continuous insulin rate over the period of 24 hours. This rate is known as the basal rate. In those with type 1 diabetes, the pancreas is no longer able to produce insulin, therefore, treatment options such as multiple daily shots and an insulin pump must be used to provide both the bolus (meal time) and basal insulin rate. The MiniMed 670G closed loop system will offer those with type 1 diabetes much greater freedom in their day to day lives. It can provide them with the ability to not have to consistently monitor their blood sugar levels multiple times a day. The system was created to adjust the levels of insulin provided with very little input from the patient. It can administer and even withhold insulin from the blood sugar readings received. The system comes with a continuous glucose sensor that attaches to the body to check the blood sugar levels under the skin, an insulin pump is also attached to the body by and infusion patch which uses a tiny catheter to deliver the insulin doses. I recommend reading the following articles: Diabetes Experts Share Ways To Lower Your A1C Levels The continuous glucose monitors or CGM will communicate with the insulin pump to help deliver insulin freely. By measur Continue reading >>

Fda Approves Tandem’s Insulin Pump With Dexcom Cgm Integration

Fda Approves Tandem’s Insulin Pump With Dexcom Cgm Integration

Tandem Diabetes Care has earned FDA approval for its touchscreen insulin pump for use with Dexcom’s continuous glucose monitor. The combined system is the first approved sensor-augmented insulin pump that allows patients to make treatment decisions without pricking their finger. Dexcom’s G5 CGM system uses a sensor, inserted just under the skin, to measure glucose levels in the interstitial fluid. It is the only FDA-approved therapeutic CGM, meaning it is used to inform treatment decisions. Other CGMs on the market are used as adjunct devices—the information they provide must be used alongside data from other devices, such as blood glucose meters. However, the Dexcom system does require frequent fingerstick calibration, to ensure the sensor is on track. The integration is approved for patients aged 6 and older. Tandem is rolling out the new software to people who already use its t:slim X2 insulin pump via a remote update. Now, users may view their insulin delivery activity alongside CGM data from the Dexcom sensor on the t:slim X2’s screen. RELATED: Medicare unveils coverage criteria for Dexcom G5 continuous glucose monitor Tandem’s device is the only insulin pump that allows users to perform remote updates using a personal computer: “The t:slim X2 Pump is designed to accelerate the pace in which we can bring new innovations to people with diabetes, which is of particular importance as we develop software updates to add automated insulin delivery algorithms to our platform,” said Tandem CEO Kim Blickenstaff in a statement. “Dexcom has been moving its technology forward at a rapid pace, and Tandem’s ability to roll out remote software updates like this opens up exciting possibilities for faster integrations of our future products,” said Steve Pacelli, Continue reading >>

Fda Approves World's First Automated Insulin Pump For Diabetics

Fda Approves World's First Automated Insulin Pump For Diabetics

The US Food and Drug Administration has approved Medtronic’s MiniMed 670G, a medical device that monitors a diabetic’s sugar levels, and then automatically injects the required dose of insulin. This first-of-its kind automated insulin delivery system was approved for people over the age of 14 who have type 1 diabetes, and it’s poised to make life considerably easier for the millions of Americans who suffer from this condition. People with type 1 diabetes can’t produce enough insulin, a hormone that regulates the amount of glucose, or sugar, in our blood. So they must replenish their insulin stock either with multiple daily injections, or by pumping insulin through a tiny catheter. Unlike these manual techniques, Medtronic’s MiniMed 670G is a “hybrid closed system,” meaning it autonomously tracks glucose levels about every five minutes or so, and then adjusts insulin levels with little or no input from the user. “[MiniMed 670G] 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,” the FDA’s Jeffrey Shuren said in a release. MiniMed 670G includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump that’s strapped to the body, and a catheter that delivers the insulin. The insulin delivery site needs to be changed about twice a week. The device has been referred to as an “artificial pancreas,” but that’s probably not the best description. The device is not an internal organ, and it’s not completely autonomous. People with type 1 diabetes still need to track their carbohydrate intake, and then enter that information into the system. The FDA approved Medtronic’s MiniMed 670G followin Continue reading >>

Genome | Personalized Insulin Pumps Help Patients With Type 1 Diabetes

Genome | Personalized Insulin Pumps Help Patients With Type 1 Diabetes

Personalized Insulin Pumps Help Patients With Type 1 Diabetes Managing type 1 diabetes is a full-time job, one that bears an unrelenting reminder of the chronic disease through daily injections and pinpricks. But a new clinical trial for a personalized intervention could pave the way to easing the burden for patients with diabetes. Sponsored by Medtronic, the multicenter nationwide trial is testing a first-of-its-kind, FDA-approved system that uses artificial intelligence to monitor and control participants blood glucose levels. Medtronic first released the MiniMed 670G device used in the trial in 2016 after the FDA decided to fast-track the systems approval. Now, investigators are enrolling patients for the second cohort of Medtronics four-year clinical trial with the aim of having 1,000 subjects complete the study. The trial divides subjects into three cohorts: those currently using insulin pumps but not blood glucose sensors ; those using a pump and a sensor; and those using neither pumps nor sensors. Linda Aman, a sub-investigator on the trial, has patients who drive several hours to participate at the Grunberger Diabetes Institute, one of the trial sites in Bloomfield Hills, Michigan, for the promise of a more automated insulin delivery system. Basically what this pump does, it is supposed to reduce the burden of taking care of [type 1] diabetes, Aman says. Its a very high burden. You have to deliver your insulin somehow either with a pump or with injections or you can inhale it. But you have to do all this in contest with what your blood sugars are doing, so you need to test those frequently. Some people test as much as 10 times a day. There are people who are just more adept at doing that than others. The MiniMed 670G system includes both an insulin pump and a c Continue reading >>

Fda Approves The Guardian Connect System, The Worlds First Smart Cgm To Help People Outsmart Their Diabetes

Fda Approves The Guardian Connect System, The Worlds First Smart Cgm To Help People Outsmart Their Diabetes

Home Innovation FDA APPROVES THE GUARDIAN CONNECT SYSTEM, THE WORLDS FIRST SMART CGM TO HELP PEOPLE OUTSMART THEIR DIABETES FDA APPROVES THE GUARDIAN CONNECT SYSTEM, THE WORLDS FIRST SMART CGM TO HELP PEOPLE OUTSMART THEIR DIABETES Posted by Karrie Hawbaker On March 12, 2018 In Innovation Im thrilled to share some great news we just received FDA approval for a new category of smart, standalone CGM, the Guardian Connect system ! Whats more, people using this system have exclusive access to the groundbreaking Sugar.IQ smart diabetes assistant . Louis Dias recently wrote about our culture of listening at Medtronic. As weve listened to you, one of the things youve taught us is that every persons journey with diabetes is unique and that you need different types of technologies to support you at different times during this journey. Thats why we created the Guardian Connect system. As proud as we are of our world-leading automated insulin delivery systems, we know plenty of people living with diabetes prefer multiple daily injections (MDI) to insulin pump therapy. But, for those of you on MDI weve also heard that you want valuable information to help you make better, more informed decisions about your diabetes so you can focus on your life. To do that, we created not just another continuous glucose monitor (CGM), but a smart standalone CGM. Smart monitoring with the power to predict The Guardian Connect system continuously measures your glucose levels and delivers them right to your smartphone every 5 minutes. More importantly, its the only standalone CGM system that uses smart technology to predict where your glucose levels are headed. It alerts you from 10-60 minutes in advance that youre predicted to hit a low or high glucose threshold that youve previously set. This means Continue reading >>

Fda Approves Tandem’s T:slim X2 Pump With Integrated Dexcom G5 Cgm

Fda Approves Tandem’s T:slim X2 Pump With Integrated Dexcom G5 Cgm

By Maeve Serino and Adam Brown Free software upgrade for t:slim X2 users, first G5-integrated pump on the market, CGM can be used for insulin dosing and remote monitoring Tandem just recently announced FDA approval and launch of its t:slim X2 insulin pump with integrated Dexcom G5 CGM. The update allows data from the G5 CGM transmitter to be sent directly to the t:slim X2 insulin pump screen, both a convenience win and paving the way for future critical updates that add automated insulin delivery. The t:slim X2 with G5 is approved for people 6 years and older, and users can still see their CGM data at the same time on Dexcom’s own iOS and Android smartphone apps. Tandem is the first company to launch a Dexcom G5-integrated pump – Animas’ One Touch Vibe Plus was approved last December, but still hasn’t launched. Current t:slim X2 users can add G5 integration to their pump for free using the Tandem Device Updater (check out diaTribe columnist Kerri Sparling’s post on how easy it is to do!). These customers will receive an email with instructions on how to update their pump’s software at home. Updating insulin pump software at home for free allows people with diabetes to avoid the hassle and cost of getting a new pump – a major win. With its software update capabilities, Tandem’s t:slim X2 can now keep up with innovations that happen within a pump’s four-year warranty cycle. Similar to the standalone G5, Dexcom data displayed on the t:slim X2 can be used for insulin dosing decisions. The G5 still requires two fingersticks per day for calibration, and these can be entered on the pump screen or in Dexcom’s smartphone app. Since the G5 on-body transmitter can communicate with both the t:slim X2 and G5 app, using one device will automatically update the oth Continue reading >>

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