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New Insulin Patch Gets Fda Approval

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 >>

J&j's Insulin Patch Finally Heading For Launch

J&j's Insulin Patch Finally Heading For Launch

J&J's insulin patch finally heading for launch By Gareth Macdonald Johnson & Johnson has finally announced a launch schedule for its One Touch Via insulin patch - some four years after it was first approved in the US. The patch is designed to be more discreet than injections for people taking insulin one demand - for example at mealtimes - and according to J&J that translates to higher rates of compliance with therapy and a reduction in embarrassment and discomfort for patients. The company's Calibra Medical subsidiary is now planning to launch the drug in "limited markets" outside the US later this year, with a launch in the following "shortly thereafter," said a company spokesperson. The delay to the launch since the FDA approval in 2012 came about because J&J was streamlining and automating the production process for the patch, which was formerly known as Calibra Finesse , she said, but would not go into any further details about J&J's launch plans. According to J&J's worldwide vice president of R&D and innovation for diabetes care, Adrian Chernoff, 57% of diabetes patients are missing injections for various reasons, and this is impairing their glucose control. "One Touch Via is worn on the abdomen under clothing and delivers two units of insulin on demand per click," he said, describing the product as a 'game changer'. "Users can easily tailor the dose by choosing the number of times they click," he added. The can be worn for up to three days - it is water-resistant and can be worn when bathing - and is completely mechanical with no need for a handheld controller, display or battery. It is designed so it can be used alongside diabetics' basal insulin injections. Data presented at the American Diabetes Association (ADA) annual meeting in June showed that more than 5 Continue reading >>

Fda Approves Admelog, The First Short-acting

Fda Approves Admelog, The First Short-acting "follow-on" Insulin Product To Treat Diabetes

Release The U.S. Food and Drug Administration today approved Admelog (insulin lispro injection), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505(b)(2) pathway). According to the Centers for Disease Control and Prevention, more than 30 million people in the U.S. have diabetes, a chronic disease that affects how the body turns food into energy and the body’s production of natural insulin. Over time, diabetes increases the risk of serious health complications, including heart disease, blindness, and nerve and kidney damage. Improvement in blood sugar control through treatment with insulin, a common treatment, can reduce the risk of some of these long-term complications. “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” said FDA Commissioner Scott Gottlieb, M.D. “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.” Admelog was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. A new drug application submitted through this pathway may rely on the FDA’s finding t Continue reading >>

Fda Approves New Smart Insulin Pump

Fda Approves New Smart Insulin Pump

The US Food and Drug Administration (FDA) has approved the first insulin pump that can analyze information from a blood glucose monitor to adjust basal insulin dose sizes in patients older than 13 with type 1 diabetes. Some have called Medtronics MiniMed 670G an "artificial pancreas." The device is not that. It still requires user intervention. That said, it requires less intervention than any of the devices that have come before it. Insulin pumps typically deliver the hormone at a constant rate that is set by users, who periodically check their glucose levels and adjust insulin dosing as needed. Even in Manual Mode, the 670 G keeps track of its continuous glucose monitor and automatically suspends insulin delivery when glucose levels fall too low. When glucose levels rise above the threshold once again, the device resumes insulin delivery. In Auto Mode, however, the 670G takes considerably more control over the entire process. The device continuously adjusts the amount of insulin it delivers from 1 minute to the next based upon readings from the continuous glucose monitor. The goal is to keep glucose levels as steady as possible. If all goes well, the only time the user must intervene in the insulin delivery process is at mealtimes, which require a manual insulin infusion matched to the size and makeup of the meal. 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, MD, JD, director of the FDAs Center for Devices and Radiological Health, speaking in an announcement from the FDA . This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without ha Continue reading >>

Medtronic Gets Fda Approval For Automated Insulin Delivery Device

Medtronic Gets Fda Approval For Automated Insulin Delivery Device

Medtronic gets FDA approval for automated insulin delivery device The latest version of the firm's MiniMed unit can learn, react to a patient's personal needs. Video (00:32) : Intl Diabetes Center lead researcher Dr. Rich Bergenstal reacts to the news of FDA approval. Video courtesy HealthPartners Institute. In a quick approval, the U.S. Food and Drug Administration on Wednesday gave a green light to the first medical device for type 1 diabetes that can automate varying doses of insulin 24 hours a day using a real-time sensor and an advanced computer program that learns a patients personal needs. Medtronic PLCs MiniMed 670G hybrid closed-loop system received approval from the FDA just three months after the Minnesota-run device maker submitted its premarket application for approval. The application was based on data from a 10-site clinical trial that found 124 type 1 diabetes patients using the device stayed within their desired blood-sugar ranges for three months without any severe complications. The MiniMed 670G hybrid closed loop system, often referred to as an artificial pancreas, is intended to adjust insulin levels with little or no input from the user, FDA officials wrote Wednesday in announcing the first-of-its-kind device. The pancreas is the organ that produces insulin to keep blood sugar called glucose in check. In type 1 diabetes, formerly known as juvenile diabetes, the immune system attacks cells in the pancreas that produce insulin, forcing the patient to inject insulin daily to stay alive. JDRF, an advocacy group for patients with the chronic disease, estimates 1.25 million Americans have type 1 diabetes, including 200,000 children. Patient advocates and engineers have long wanted a device that could combine a glucose sensor, sophisticated programming a Continue reading >>

Fda Approves Insulin 'patch Pen,' Now It Just Needs Funds

Fda Approves Insulin 'patch Pen,' Now It Just Needs Funds

We're sorry, an error occurred. We are unable to collect your feedback at this time. However, your feedback is important to us. Please try again later. Calibra Medical's new insulin "patch pen," brand-named Finesse, has been approved by the FDA and performed extremely well in recent patient studies. The product could be a huge hit if the company can secure the financial backing it needs to get production off the ground, according to the physician leading their research charge. So let's start at the beginning here: What the heck is a "patch pen," anyway? That's what I wan ted to know. Most people would refer to Finesse as a patch pump , being the more common term for an insulin delivery device worn on the skin like a bandage. This one is extremely small and flat (2" 1" 0.25"), and contains a 200-unit insulin reservoir. It delivers bolus doses only, which can be accomplished right through your clothing by squeezing together the 2 buttons on its sides. It's targeted at both type 1 and type 2 patients currently on injections, as a much easier and more discrete way to deliver mealtime, snack, and correction boluses. It's been FDA approved for up to 3 days' use with Novolog rapid-acting insulin. (Patients still need to inject their long-acting insulin.) For more details on the design, see Bernard's review here . "Pumps are coming under great FDA scrutiny right now. I guess they're calling it a patch pen because it delivers bolus doses only, replacing the dosing patients would normally do with an insulin pen," says Dr. Nancy Bohannon, director of clinical research at the Cardiovascular Risk Reduction Program, St. Luke's Hospital, here in San Francisco, CA, who led the recent feasibility clinical trials for Finesse. "In my part of the study, I had 10 patients, mostly type 1s. Continue reading >>

Fda Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration

Fda Approves First Continuous Glucose Monitoring System For Adults Not Requiring Blood Sample Calibration

Release The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”). The system reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels. Users can determine glucose levels by waving a dedicated, mobile reader above the sensor wire to determine if glucose levels are too high (hyperglycemia) or too low (hypoglycemia), and how glucose levels are changing. It is intended for use in people 18 years of age and older with diabetes; after a 12-hour start-up period, it can be worn for up to 10 days. “The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.” People with diabetes must regularly test and monitor their blood sugar to make sure it is at an appropriate level, which is often done multiple times per day by taking a fingerstick sample and testing it with a blood glucose meter. Typically patients use results of a traditional fingerstick test to make diabetes Continue reading >>

Dexcom G6 Integrated Continuous Glucose Monitoring System Gets Fda Approval

Dexcom G6 Integrated Continuous Glucose Monitoring System Gets Fda Approval

Dexcom G6 Integrated Continuous Glucose Monitoring System Gets FDA Approval The Food and Drug Administration (FDA) has authorized the marketing of the Dexcom G6 integrated continuous glucose monitoring (iCGM) system for determining glucose levels in patients aged2 years with diabetes. This marks the first type of CGM system permitted for use as part of an integrated system with other compatible medical devices and electronic interfaces such as automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices for managing diabetes . The Dexcom G6 patch contains a small sensor which is applied to the abdomen. It continuously measures glucose levels and transmits readings every 5 minutes to a compatible display device (eg, mobile app). If the patient's glucose level is too high or too low, it triggers an alarm to alert the patient. If integrated with an automated insulin dosing system, a glucose spike would trigger insulin release from the pump. Dexcom G6 was evaluated in 2 clinical studies (N=324) that included adults and children aged2 years with diabetes. During multiple clinical visits over a 10-day period, the system's readings were compared against a lab test method to measure blood glucose. There were no serious adverse events reported during the trials. Toujeo Max SoloStar Gets FDA Approval for Patients With Diabetes Different from the earlier Dexcom G5 model, the G6 model already comes factory calibrated eliminating the need for a patient fingerstick to calibrate the sensor. Moreover, its updated sensor probe also minimizes interference with concomitant acetaminophen. The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet pe 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 First Blood Sugar Monitor Without Finger Pricks

Fda Approves First Blood Sugar Monitor Without Finger Pricks

FDA approves first blood sugar monitor without finger pricks The FDA has approved a device from Abbott that continuously monitors diabetics’ blood sugar levels without requiring backup finger prick tests. .S. regulators have approved the first continuous blood sugar monitor for diabetics that doesn’t need backup finger prick tests. Current models require users to test a drop of blood twice daily to calibrate, or adjust, the monitor. The pain of finger sticks and the cost of testing supplies discourage many people from keeping close tabs on their blood sugar, which is needed to manage insulin use and adjust what they eat. Abbott’s new FreeStyle Libre Flash Glucose Monitoring System , approved Wednesday by the Food and Drug Administration, uses a small sensor attached to the upper arm. Patients wave a reader device over it to see the current blood sugar level and changes over the past eight hours. Most of the 30 million Americans with diabetes use standard glucose meters, which require multiple finger pricks each day and only show current sugar level. More-accurate continuous glucose monitoring devices are used by about 345,000 Americans. Sign up for our Morning Rounds newsletter But most don’t do the finger pricks to calibrate them and may get inaccurate readings, said Dr. Timothy Bailey, who helped test FreeStyle Libre. “We’re able to lower blood sugar safely” with this technology, said Bailey, director of the Advanced Metabolic Care and Research Institute in California. He receives consulting fees from various diabetes device makers. Too-high blood sugar levels can damage organs and lead to heart attacks, strokes, blindness and amputations. Very low blood sugar can cause seizures, confusion and loss of consciousness. Abbott’s device was approved for ad Continue reading >>

New Diabetes Tech On The Horizon: What’s Coming By Mid-2017 In The Us?

New Diabetes Tech On The Horizon: What’s Coming By Mid-2017 In The Us?

By Lynn Kennedy, Ava Runge, and Adam Brown What Abbott, Dexcom, LifeScan, Medtronic, Tandem, and others are bringing to make diabetes easier and less burdensome Want more news just like this? We’re living in the most exciting time ever in diabetes technology, and a slew of soon-to-launch products are going to subtract hassle from living with diabetes – fewer injections and fingersticks, less math, less data overload, less pain, and less worry. Equally important, most emerging technology shows excellent potential to improve glucose outcomes that matter, among them hypoglycemia, time-in-range, hyperglycemia, and A1c. Curious what’s coming? Read on for a summary of the insulin delivery and glucose monitoring devices expected to launch in the US by mid-2017 or earlier, based on the most recent company timelines (listed chronologically). This list is not fully comprehensive, but does cover the major device launches expected. A more detailed description of each device follows further below. New Insulin Delivery Devices Tandem’s t:slim X2 Insulin Pump – October-December 2016. The latest Tandem pump will add a new Bluetooth radio and enable software updates to add future Dexcom G5 connectivity and automated insulin delivery algorithms. Medtronic MiniMed Pro Infusion Set with BD FlowSmart technology – around late 2016. The long-awaited infusion set has several key improvements, most notably a new catheter that allows insulin to flow out of two holes (less occlusions). LifeScan’s OneTouch Via – early 2017. The bolus-only, super slim wearable device holds 200 units of insulin and can be worn for three days. Squeezing two buttons (including through clothes) – will discreetly deliver a two-unit bolus. Medtronic’s MiniMed 670G/Enlite 3 Hybrid Closed Loop – by Ap Continue reading >>

Medtronic Gets Fda Approval For Its Guardian Connect Cgm System

Medtronic Gets Fda Approval For Its Guardian Connect Cgm System

Medtronic Gets FDA Approval For its Guardian Connect CGM System Medtronic Gets FDA Approval For its Guardian Connect CGM System Medtronic has announced it received U.S. Food and Drug Administration (FDA) approval for its GuardianConnect continuous glucose monitoring (CGM) system, for people with diabetes ages 14 to 75 years. The Guardian Connect system is the first smart standalone CGM systemto help people with diabetes stay ahead of high and low glucose events. The Guardian Connect system empowers people using multiple daily injections (MDI) to more proactively manage their diabetes. The Guardian Connect system is the only standalone CGM system that can alert people with diabetes of potential high or low glucose events up to 60 minutes in advance. Using Guardian Sensor 3, the most advanced glucose sensor from Medtronic and the only sensor trusted to power a hybrid closed loop system, the Guardian Connect system was proven in a clinical study to accurately alert patients of 98.5 percent of hypoglycemic events. Care partners can use the system to stay more informed about their loved ones with diabetes as well by tracking glucose in real-time or receiving text alerts. People using the Guardian Connect system will also have access to the groundbreaking Sugar.IQ smart diabetes assistant, empowering them to further address the daily challenges of diabetes. With artificial intelligence technology from IBM Watson Health, the Sugar.IQ assistant continually analyzes how an individuals glucose levels respond to their food intake, insulin dosages, daily routines, and other factors. Together with the Guardian Connect system, the Sugar.IQ assistant can turn difficult-to-determine patterns into personalized, actionable insights that help people with diabetes keep glucose levels in t Continue reading >>

Fda Approves First-ever Blood Sugar Monitor That Doesn't Require A Fingerstick

Fda Approves First-ever Blood Sugar Monitor That Doesn't Require A Fingerstick

In a milestone for Americans with diabetes, the Food and Drug Administration (FDA) has cleared the first-ever continuous blood sugar monitoring device that doesn’t require patients to take potentially painful and invasive blood tests that require pricking their fingertips to collect samples. The approval was granted to Abbott Diabetes Care, Inc. The device, Abbott’s FreeStyle Libre Flash Glucose Monitoring System, is approved for adult diabetes patients 18 years of age and older, and the approval sent Abbott stock up 3.5% in Thursday trading. It slashes the need for the so-called fingerstick tests that people with diabetes regularly endure to figure out whether their blood sugar levels are too high or too low, and to monitor general fluctuation in blood glucose so they can adjust their diets or medication. The device itself uses an under-the-skin sensor wire which keeps tabs on sugar levels. In order to get a gauge on where those glucose levels are at, users simply have to wave an accompanying, specialized mobile reader device over the sensor like a wand. “The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” said the FDA’s Donald St. Pierre in a statement. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes—with a wave of the mobile reader.” Medical device and tech companies alike have shown growing interest in diabetes management and monitoring devices. Last year, the FDA approved an artificial pancreas from device giant Medtronic to treat people with type 1 diabetes with a largely automated glucos Continue reading >>

Fda Approves Medtronic’s New Automated Insulin Pump

Fda Approves Medtronic’s New Automated Insulin Pump

The Food and Drug Administration approved for sale a significant advance toward a so-called artificial pancreas for Type 1 diabetes patients, a long-awaited insulin pump that aims to take some of the guesswork out of blood-sugar control. The product from Medtronic MDT -0.73% PLC, called the MiniMed 670G, combines two devices that attach to the outside of the body—a pump that delivers insulin through a tiny tube inserted under the skin, and a sensor that monitors blood glucose levels. The monitor tells the pump when to increase or decrease insulin flow to keep a person’s blood sugar in a healthy range. The device isn’t fully automated—users must enter their planned carbohydrate intake at each mealtime, and adjust the sensor twice a day by carrying out finger-prick tests to measure blood sugar. But doctors and patients called the MiniMed an important breakthrough likely to improve glucose control, reduce complications and lessen the constant worry of controlling Type 1 diabetes. Existing diabetes pumps and monitors can automatically shut off insulin flow when a person’s blood sugar levels veer toward being too low. But they can’t automatically deliver insulin when a person has high blood sugar, doctors said. “We’ve been looking forward to a day like this for a long time,” Derek Rapp, chief executive of the Juvenile Diabetes Research Foundation, or JDRF, said in an interview. “Ultimately it means less concern, less burden, more freedom and less fear.” Lori Laffel, a pediatric endocrinologist at the Joslin Diabetes Center at Harvard University, said the approval was a big step forward. Even so, she said patients still need to be able to take care of their diabetes and know how to operate the pump and sensor. “It doesn’t make diabetes simply go away 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 >>

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