Fda Oks Device With No Finger-prick For Diabetes
HealthDay Reporter THURSDAY, Sept. 28, 2017 (HealthDay News) -- The first fingerstick-free blood sugar monitoring system for adults with diabetes has been approved by the U.S. Food and Drug Administration. The FreeStyle Libre Flash Glucose Monitoring System features a small sensor wire that's placed below the skin's surface and continuously monitors blood sugar (glucose) levels. People with diabetes can wave a mobile reader above the sensor wire to check their glucose levels. The system is approved for use in people with diabetes aged 18 and older. After a 12-hour start-up period, it can be worn for up to 10 days, the FDA said. "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," Donald St. Pierre said in an FDA news release. He is deputy director of new product evaluation in the FDA's Center for Devices and Radiological Health. Approval of the system, made by Abbott Diabetes Care, was based on a clinical trial of diabetes patients aged 18 and older. The system does not provide real-time alerts on its own, the FDA noted. For example, it cannot warn patients about low blood glucose levels while they're sleeping. Potential risks associated with the system include low or high blood sugar if data it provides is inaccurate and used to make treatment decisions, the FDA said. Some patients may also have mild skin irritation around the area where the sensor wire is inserted. More than 29 million people in the United States have diabetes, according to the U.S. Centers for Disease Control and Prevention. People with diabetes either don't make enough insulin (type 1 diabetes) or cannot use insulin pr Continue reading >>
"fda Approves First Blood Sugar Monitor Without Finger Prick"
U.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. 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. "The pros of the new device are that it is a 10-day wear, it is low-profile and that no calibration needed," said Carol Levy, MD, CDE, associate professor of endocrinology, diabetes and bone disease, obstetrics, gynecology and reproductive science at the Icahn School of Medicine at Mount Sinai. "The cons of the device are that is has no alerts for either high or low BG levels for patients with hypo-unawareness, which could be a challenge. It also requires a separate receiver to view data -- other systems on the market can have data viewed on the smart phone,” she added. - Carol Levy, MD, CDE, Associate Professor, Endocrinology, Diabetes and Bone Disease, Obstetrics, Gynecology and Reproductive Science, Icahn School of Medicine at Mount Sinai Continue reading >>
- Tiny sensor placed under the skin to replace finger prick tests for diabetes: Smartphone app will alert patients if their blood sugar level drops or is too high
- No More Finger Prick. New Technology May Help with Diabetes Management.
- FDA Approves MiniMed 670G System – World’s First Hybrid Closed Loop System
The Fda Has Approved A Blood Sugar Monitor That Doesn’t Require A Finger Prick
Further proof the U.S. Food and Drug Administration has been warming up to modern technology — it has just approved the first continuous blood sugar monitor that doesn’t require the user to prick themselves over and over for a blood sample. Today, the FDA cleared Abbot’s FreeStyle Libre Flash Glucose Monitoring System, a device that uses a small sensor wire inserted under the skin to determine glucose levels in adult diabetics. Another wand-like device is then waved over the sensor to measure and give a readout of those glucose levels. This is a milestone move for the FDA as diabetes affects nearly 30 million people in the United States who currently have to test their blood sugar by pricking themselves several times throughout the day and every time they eat. However, the idea for a prickless blood sugar monitor isn’t new. Tech companies have increasingly shown an interest in the massive diabetics market over the past few years. Apple is rumored to be working on such a device and its CEO Tim Cook has even been spotted wearing a possible prototype that could connect to the Apple Watch. Other companies endeavor to build something similar, including Glucowise, which has a device still under development. However, it seems it’s not so easy to create a needleless blood sugar detector. Google tried to build a contact lens that could detect glucose but it seems the project has gone nowhere since drug company Novartis licensed the tech in 2014. Another FDA-approved device for glucose monitoring without the prick called the GlucoWatch was approved in the early 2000’s, but consumers found it cumbersome and it happened to cause a bad rash in some. But there’s new hope today that the Freestyle monitor has worked out all the kinks. The device is intended for those 18 a 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
- Tiny sensor placed under the skin to replace finger prick tests for diabetes: Smartphone app will alert patients if their blood sugar level drops or is too high
Fda Approves 1st Blood Sugar Monitor Without Finger Pricks
Federal 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 discomfort of finger sticks and the cost of testing supplies can discourage people from keeping close tabs on their blood sugar. Abbott's new FreeStyle Libre Flash Glucose Monitoring System 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. The Food and Drug Administration approved the device Wednesday. Abbott isn't disclosing the price for the reader or the sensors, which should be available in pharmacies within months. Continue reading >>
Fda Approves First Blood Sugar Monitor Without Finger Prick
FDA approves first blood sugar monitor without finger prick Tools used to check blood sugar and insulin to level blood sugar for a diabetic. (Photo: Pixabay) (CBS) -- U.S. regulators have approved the first continuous blood sugar monitor for diabetics that does not need backup finger prick tests. Current models require users to test a drop of blood twice daily to calibrate, or adjust, the monitor. Though keeping an eye on blood sugar levels is needed to manage insulin, many people are wary of monitoring it because of the pain and cost of current testing methods. The new model, Abbott's new FreeStyle Libre Flash Glucose Monitoring System, was approved by the Food and Drug Administration on Wednesday. Users wave a reader device over a small sensor attached to the upper arm to see current blood sugar levels and changes over the last eight hours. Most of the 30 million Americans diagnosed with diabetes use standard glucose monitors which require multiple finger pricks every day. Abbott's device was approved for adults with Type 1 or Type 2 diabetes and should be available in pharmacies within months. The company did not release information on the price of the product. The device can't be used with an insulin pump, but the company is planning improvements that will allow that. "The pros of the new device are that it is a 10-day wear, it is low-profile and that no calibration needed," said Dr. Carol Levy, director of the Mount Sinai Diabetes Center in New York City. "The cons of the device are that is has no alerts for either high or low BG levels for patients with hypo-unawareness, which could be a challenge. It also requires a separate receiver to view data -- other systems on the market can have data viewed on the smart phone." Continue reading >>
- Tiny sensor placed under the skin to replace finger prick tests for diabetes: Smartphone app will alert patients if their blood sugar level drops or is too high
- No More Finger Prick. New Technology May Help with Diabetes Management.
- FDA Approves MiniMed 670G System – World’s First Hybrid Closed Loop System
Device To Keep Tabs On Blood Sugar Levels Without Finger-pricking Available In Singapore
SINGAPORE: When Mr Kevin Lim was diagnosed with diabetes in June last year, the 40-year-old wanted to do all he could to improve his condition. The first step would be to start monitoring his blood glucose levels so he could get a better sense of the severity of his diabetes. With that, however, he faced the inevitable task of pricking his finger almost daily - or so he thought. Through some research, Mr Lim, who works in an innovation lab, discovered a flash glucose monitoring device online that he could buy and use at home that could do away with the need for pricking his fingers. Self-monitoring for diabetes patients typically involves pricking the finger for a drop of blood that has to be transferred onto a test strip and read with a small machine. The flash glucose monitoring device measures the glucose level of tissue fluid through a sensor about the size of an old Singapore 50-cent coin. The sensor is attached to the back of the upper arm by painless self-insertion and an adhesive pad. Readings are made by scanning the sensor with a separate machine. The sensor that can be worn for up to two weeks and holds eight hours of 15-minute glucose readings at any time is water-resistant. Mr Lim ordered it on eBay, but the device, that for a few years has been available in the US and Europe, landed in Singapore in May this year. Advertisement With the device, Mr Lim has been able to observe which foods cause his blood glucose level to spike, which activities help him to maintain a healthy blood sugar level, and whether the medication he was prescribed were effective. In diabetic patients, high blood glucose levels after a meal has been linked to heart disease. The monitoring being more discreet than finger-pricking is something Mr Lim appreciates. “It’s demoralising t Continue reading >>
- World's first diabetes app will be able to check glucose levels without drawing a drop of blood and will be able to reveal what a can of coke REALLY does to sugar levels
- Israeli device banishes finger-pricking for sugar levels in diabetes patients
- The FreeStyle Libre, a device for monitoring blood sugar, is a pleasure to use.
The Fda Just Approved A Device That Can Monitor Blood Sugar Without Finger Pricks
Abbott's device continuously monitors blood sugar levels.Abbott The FDA on Wednesday approved a device that monitors blood sugar levels without needing to draw blood via a finger prick. The device, which is made by Abbott and called the "FreeStyle Libre Flash Glucose Monitoring System," continuously monitors a person's glucose level via a sensor that's stuck on the body. It's the first device of its kind that doesn't require users to calibrate the system with a traditional finger-prick blood draw twice a day. "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," the FDA's Donald St. Pierre said in a news release. For people living with diabetes, checking blood sugar levels with a drop of blood from the finger is a common practice. Diabetes is a condition in which people have a hard time processing sugar, which can lead to complications if those levels get too high or drop too low. Continuous monitoring lets you see not only when blood sugar is too high or too low, but also whether it is rising or falling. According to a review of literature by the American Association of Clinical Endocrinologists, testing blood sugar more frequently tends to be related to better blood sugar control. Abbott's competitor Dexcom, which still requires the finger sticks for calibrating its device, was down 34% on the news Thursday. "The clear loser in the FDA’s decision is Dexcom," Jefferies analyst Raj Denhoy said in a note Wednesday. That's because on paper, Abbott's device looks better since it doesn't require finger pricks, has better accuracy, and is cheaper. "We believe we've got something here that's rev Continue reading >>
Scientists Develop Patch To Monitor Blood Glucose Without Finger-prick Tests
Scientists develop patch to monitor blood glucose without finger-prick tests Scientists have created a non-invasive patch to measure glucose levels through the skin potentially removing the need for millions of diabetics to carry out finger-prick blood tests. The patch draws out glucose from fluid between cells across hair follicles, which are individually accessed through a set of miniature sensors using a small electric current. It does not pierce the skin. Glucose collects in tiny reservoirs and is measured, with readings taken every 10 to 15 minutes over several hours. The patch, developed by University of Bath scientists, has been tested on pig skin and human volunteers (University of Bath/PA) Researchers say the array of sensors and reservoirs on the patch mean it does not require calibration with a blood sample, making finger-prick blood tests unnecessary. The team, from the University of Bath, hope the patch will become a low-cost, wearable sensor that sends regular, clinically relevant glucose measurements to a phone or smartwatch wirelessly alerting patients when they may need to take action. Their work is published in the journal Nature Nanotechnology. Professor Richard Guy, from the universitys Department of Pharmacy & Pharmacology, said: A non-invasive that is, needle-less method to monitor blood sugar has proven a difficult goal to attain. The closest that has been achieved has required either at least a single-point calibration with a classic finger-stick, or the implantation of a pre-calibrated sensor via a single needle insertion. The monitor developed at Bath promises a truly calibration-free approach, an essential contribution in the fight to combat the ever-increasing global incidence of diabetes. An important advantage of the patch is that each min Continue reading >>
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 >>
Non-invasive, Adhesive Patch Promises Measurement Of Glucose Levels Through Skin Without Finger-prick Blood Test
Non-invasive, adhesive patch promises measurement of glucose levels through skin without finger-prick blood test The sensor array is designed to draw fluid across a single hair follicle. Credit: University of Bath Scientists have created a non-invasive, adhesive patch, which promises the measurement of glucose levels through the skin without a finger-prick blood test, potentially removing the need for millions of diabetics to frequently carry out the painful and unpopular tests. The patch does not pierce the skin, instead it draws glucose out from fluid between cells across hair follicles, which are individually accessed via an array of miniature sensors using a small electric current. The glucose collects in tiny reservoirs and is measured. Readings can be taken every 10 to 15 minutes over several hours. Crucially, because of the design of the array of sensors and reservoirs, the patch does not require calibration with a blood samplemeaning that finger prick blood tests are unnecessary. Having established proof of the concept behind the device in a study published in Nature Nanotechnology, the research team from the University of Bath hopes that it can eventually become a low-cost, wearable sensor that sends regular, clinically relevant glucose measurements to the wearer's phone or smartwatch wirelessly, alerting them when they may need to take action. An important advantage of this device over others is that each miniature sensor of the array can operate on a small area over an individual hair follicle - this significantly reduces inter- and intra-skin variability in glucose extraction and increases the accuracy of the measurements taken such that calibration via a blood sample is not required. The project is a multidisciplinary collaboration between scientists from Continue reading >>
Fda Approves 1st Blood Sugar Monitor Without Finger Pricks
FDA approves 1st blood sugar monitor without finger pricks The Food and Drug Administration has approved Abbott Laboratories' FreeStyle Libre flash glucose monitoring device, which continuously monitors diabetics blood sugar levels without requiring backup finger prick tests. Federal 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 discomfort of finger sticks and the cost of testing supplies can discourage people from keeping close tabs on their blood sugar. Abbott's new FreeStyle Libre Flash Glucose Monitoring System 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. The Food and Drug Administration approved the device Wednesday. Abbott isn't disclosing the price for the reader or the sensors, which should be available in pharmacies within months. Copyright, Telegraph Herald. This story cannot be published, broadcast, rewritten or redistributed without prior authorization from the TH. Continue reading >>
Fda Approves First Blood Sugar Monitor Without Finger Pricks
FDA approves first blood sugar monitor without finger pricks JUST IN: New restaurant at The Greene to open April 23 Prosecutor: Ohio high school teacher allegedly had sex with student in parking lot 3 booked into local jails face federal prosecution, deportation FDA approves first blood sugar monitor without finger pricks JUST IN: New restaurant at The Greene to open April 23 Prosecutor: Ohio high school teacher allegedly had sex with student in parking lot 3 booked into local jails face federal prosecution, deportation FDA approves first blood sugar monitor without finger pricks Published: Saturday, September 30, 2017 @ 2:07 AM By: Bob DAngelo, Cox Media Group National Content Desk First Blood Sugar Monitor Without Finger Pricks Approved by FDA Diabetics who dont like pricking their fingers to monitor blood sugar may have an alternative method to check their levels. Federal regulators have approved the first continuous device that will bypass the finger prick tests, according to the Food and Drug Administration . Current models require users to test a drop of blood twice a day. Abbott's new FreeStyle Libre Flash Glucose Monitoring System , approved Wednesday by the FDA, 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. 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 FDAs Center for Devices and Radiological Health. This system allows people with diabetes to avoid the additional step of fingers Continue reading >>
Fda Approves First Blood Sugar Monitor Without Finger Prick
U.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. 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 adults with Type 1 or Type 2 diabetes and should be available in pharmacies within months. The company, based near Chicago, did not disclose the price of the reader or the sensors. Abbott's system can't be used with an insulin pump, a device worn against the skin th Continue reading >>
- Tiny sensor placed under the skin to replace finger prick tests for diabetes: Smartphone app will alert patients if their blood sugar level drops or is too high
- No More Finger Prick. New Technology May Help with Diabetes Management.
- FDA Approves MiniMed 670G System – World’s First Hybrid Closed Loop System
Fda Approves First Blood Sugar Monitor Without Finger Pricks
First Blood Sugar Monitor Without Finger Pricks Approved by FDA FDA approves first blood sugar monitor without finger pricks Bob DAngelo, Cox Media Group National Content Desk Diabetics who dont like pricking their fingers to monitor blood sugar may have an alternative method to check their levels. Federal regulators have approved the first continuous device that will bypass the finger prick tests, according to the Food and Drug Administration . Current models require users to test a drop of blood twice a day. Abbott's new FreeStyle Libre Flash Glucose Monitoring System , approved Wednesday by the FDA, 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. 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 FDAs 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. 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. Abbott's device was approved for adults with Type 1 or Type 2 diabetes and should be available in pharmacies within months, according to The Associated Press. The company, based nea Continue reading >>
Fda Approves 1st Blood Sugar Monitor Without Finger Pricks
FDA approves 1st blood sugar monitor without finger pricks Federal regulators have approved the first continuous blood sugar monitor for diabetics that doesn't need backup finger prick tests. Federal 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 discomfort of finger sticks and the cost of testing supplies can discourage people from keeping close tabs on their blood sugar. Abbott's new FreeStyle Libre Flash Glucose Monitoring System 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. The Food and Drug Administration approved the device Wednesday. Abbott isn't disclosing the price for the reader or the sensors, which should be available in pharmacies within months. Digital access or digital and print delivery. Continue reading >>
