In october 2014, we launched our software 505 algorithm for the g4 platinum, an algorithm which enabled our systems to achieve a single digit mard a measure of the accuracy of continuous glucose monitoring. Software update for dexcom g4 platinum receiver 505. Page 2 indications for use and safety statement dexcom g4 platinum users guide dexcom g4 platinum. Dexcom or your distributor will discuss your individual path to upgrade to the dexcom g6 the next time you place an order for supplies. Dexcom software with artificial pancreas algorithm i am. Singledigit mard demonstrated in software used in dexcom g5. Since then, dexcom has upgraded their system to the new dexcom g4 platinum. Buy dexcom g5 mobile g4 platinum sensor 2017dating on free shipping on qualified orders. Our outstanding accuracy, along with exceptional sensing performance, results in a reliable cgm you can trust 1. Dexcom g4 platinum with software 505 is the first and only cgm system on the market with a singledigit mard mean absolute relative difference measurement, below 10 percent. The new 505 software is the version currently being used in artificial pancreas trials.
Is there any significant difference between dexcom g4 and. When it comes to glucose sensing, dexcom sets the standard. Hypoglycemia reduction and accuracy of continuous glucose. Dexcom g4 platinum professional user guide dexcom provider. Facebook is showing information to help you better understand the purpose of a page. The new software 505 features the same advanced algorithm as used in artificial pancreas research. Continuous glucose monitoring cgm provides information unattainable by intermittent capillary blood glucose, including instantaneous realtime display of glucose level and rate of change of glucose, alerts and alarms for actual or impending hypo and hyperglycemia, 247 coverage, and the ability to characterize glycemic variability.
The dexcom g4 platinum system is indicated for use as an adjunctive device. Dexcom receiver usb cable dexcom canada online store. It is now available to dexcom users as a free download on dexcom. The software will be made available free of charge to adult patients using the dexcom g4 platinum. Those who already use a dexcom can run an update tool to add the algorithm onto their existing g4 platinum receiver, and any newly purchased dexcoms will come with the new software already included. Fda approves dexcom software with artificial pancreas. With the dexcom g4 platinum system with share tm, youll get a cgm thats not only appealing but one that delivers results consistently and accurately 1. In particular, the errors reported for both dexcom g4 platinum and dexcom g4 platinum software 505 fall on this curve see fig. Food and drug administration fda has approved new software for the dexcom g4 platinum cgm. Diabeticdig, dexcom g4 platinum, new transmitter and. In addition, the reported error levels of dexcom g4 platinum software 505 are below the thresholds that would allow cgm use for insulin dosing decisions i. The new software 505 features the same advanced algorithm as used. Charge your receiver or upload receiver data to dexcom clarity, our cloudbased glucose data software, on a computer or laptop.
Nov 06, 2014 we are pleased to announce that dexcom has received approval for its dexcom g4 platinum with new software 505. Plus, while other brands have rigid, rectangular probes, the dexcom g4 platinum sensor is a round, comfortdesign, making it flexible, comfortable, and bodyfriendly. The dexcom g4 platinum continuous glucose monitoring system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons age 18 and older with diabetes. You can use your android or iphone device to check your blood sugar. This study was designed to evaluate accuracy, performance, and safety of the dexcom san diego, ca g4 platinum continuous glucose monitoring cgm system g4p compared with the dexcom g4 platinum with software 505 algorithm sw505 when used as adjunctive management to blood glucose bg monitoring over a 7day period in youth, 217 years of age, with diabetes. In this openlabel, singlearm, multicenter clinical study, the dexcom g4platinum continuous glucose monitoring cgm system which uses the same software 505 as the dexcom g5mobile cgm system was evaluated for accuracy in 51 subjects 18 years of age or older. Accuracy of continuous glucose monitoring cgm devices in hypoglycemia has been a widely reported shortcoming of this technology.
Fda approves dexcom software with artificial pancreas algorithm. We report the accuracy in hypoglycemia of a new version of the dexcom san diego, ca g4 platinum cgm system software 505 and present results regarding the optimum setting of cgm hypoglycemic. This is available to our existing customers for free via the dexcom update tool. Aug 25, 2015 for those not hip to what the dexcom g4 platinum and now the g5 offer as to basics, heres a glimpse. Nov 06, 2014 san diego, nov 06, 2014 business wire dexcom, inc. As soon as the availability of the new dexcom g4 platinum 505 software was announced, i wanted download it. Randomized, controlled trial conducted in 12 diabetes practices throughout germany. Pitting vibes cgm against my updated dexcom receiver shown here displayed on a remote monitor, it was clearly behind this rising blood sugar. While meters give a number for a single point in time, cgm provides dynamic glucose information by showing where glucose is, where its going, and how fast its getting there. The dexcom g4 platinum sensor, transmitter, and receiver must be removed prior to magnetic resonance imaging mri, ct scan, or diathermy treatment. Dexcom software update diabetes forum the global diabetes.
Dexcom g4 platinum continuous glucose monitor receiver. Page 169 1012 hours software 505 original 1214 hours software 505 cgm readings are within 40 to 400 mgdl, inclusive. Dexcoms continuous glucose monitor now with artificial. Hypoglycemic accuracy and improved low glucose alerts of the. Dxcm said today that the fda approved new artificial pancreas software for its g4 platinum continuous glucose monitor. The 505 software is currently not approved for the pediatric version of the g4 but dexcom announced that they will be applying with the fda in the last quarter of 2014 thats any day. The original dexcom g4 algorithm was less accurate than the most recent dexcom s algorithm. How do i update the software on my dexcom cgm system. In plain language, your platinum g4 without the new algorithm has a % mard, the new. It is intended for use as an accessory to dexcom cgm devices with data interface capabilities. We are pleased to announce that dexcom has received approval for its dexcom g4 platinum with new software 505. The dexcom g4 platinum system is indicated for use as. Dexcom g4 platinum continuous glucose monitoring system receiver with share 232 pages blood glucose meter dexcom g4 platinum quick start manual.
In unexpected news, dexcom recently announced the fda approval of the g4ap algorithm called software 505, a new software that improves the accuracy of the dexcom, strengthening the accuracy vs. Improved accuracy of continuous glucose monitoring systems. Diabeticdig discusses the new dexcom g4 platinum transmitter and software update 505. Dexcom g4 platinum g5 mobile cgm systems is dexcom share available internationally. The dexcom g4 platinum sensors box of 4 is the smallest sensor available about the size of 2 human hairs. Nope, ten days ago i also upgraded my dexcom to the new advanced. If you are using the dexcom g5 mobile app, please check if your smart device is compatible prior to purchase. Dexcom g4 platinum system using an advanced algorithm. Nov 10, 2014 diabeticdig discusses the new dexcom g4 platinum transmitter and software update 505. Research designmethods 24week, randomized, controlled trial of 158 adults with type 1 diabetes.
Nov 06, 2014 patients will be able to go online and download the software, or they will receive the software preloaded onto their dexcom receiver with new orders, said terrence gregg, ceo, dexcom. Page 22 settings to change the time, date and transmitter id, to look chapter 2 up your dexcom g4 system hardware and software version numbers, to view transmitter battery status, last calibration. The new transmitter model with builtin bluetooth is about the size of the original g4 transmitter before the thinner model released last year, dexcom tells. Test strips based on glucose oxidase biosensor god technology. Update your receiver for detailed stepbystep instructions please visit the dexcom update tool user guide.
The animas vibe runs the original dexcom g4 platinum algorithm and not the new and improved 505 software update available to download for your nonpediatric adult dexcom g4 receiver here. Dexcom releases free software update for dexcom cgm users. The studies involved 79 pediatric5 and 51 adult6 subjects who provided. This latest software enhancement to the dexcom g4 platinum will make the performance level comparable to episodic blood glucose finger sticks. Updated for dexcom share fda approval dexcom, headquartered in san diego, california, is focused on developing technology for continuous glucose monitoring to improve the lives of people with diabetes. Is there any significant difference between dexcom g4 and g5. What are the minimum requirements to run the dexcom studio software. If you could not find answers to your questions, contact us directly for help. The upgrade is free, better and the next step toward cgm data that perhaps one day youll be able to dose insulin from might as well do it. The new software 505 features the same advanced algorithm as used in. In plain language, your platinum g4 without the new algorithm has a % mard, the new software clocks in at 9% mard a lower mard is more accurate.
Improved accuracy of continuous glucose monitoring systems in. The 230page document provides indepth coverage of the system, including. The system is intended for use by patients at home and in healthcare facilities. The algorithm converts sensor electrical signal to glucose values. The dexcom continuous glucose monitoring g4 platinum system helps to do what a typical meter cannot. Singledigit mard demonstrated in software used in dexcom g5 mobile cgm system in this openlabel, singlearm, multicenter clinical study, the dexcom g4 platinum continuous glucose monitoring cgm system which uses the same software 505 as the dexcom g5 mobile cgm system was evaluated for accuracy in 51 subjects 18 years.
The original dexcom g4 algorithm was less accurate than the most recent dexcoms algorithm. Their dexcom sts system was approved by the fda on march 27, 2006. Will they still work with the new dexcom g4 platinum receiver with share. The dexcom g4 platinum system has not been tested during mri, ct scans or with diathermy treatment, and it is unknown if there are safety or performance issues.
In this openlabel, singlearm, multicenter clinical study, the dexcom g4 platinum continuous glucose monitoring cgm system which uses the same software 505 as the dexcom g5 mobile cgm system was evaluated for accuracy in 51 subjects 18 years. Page 2 indications for use and safety statement dexcom g4 platinum users guide dexcom g4 platinum continuous glucose monitoring system. Existing adult users of the dexcom g4 platinum can download the new software for their device at no charge from the. It is now available to dexcom users as a free download on dexcom s website. Better accuracy with new dexcom g4 algorithm and the path ahead im paying superclose attention to my dexcom cgm continuous glucose monitor these days, and not just because im a nightscout newbie. Dexcom will be trying to obtain approval in pediatrics within the following months. The dexcom g4 platinum professional continuous glucose monitoring system the system is a glucose monitoring device indicated for detecting trends and tracking patterns in persons age 18 and older with diabetes. Dxcm, a leader in continuous glucose monitoring cgm, announced today that the u. Continuous glucose monitoring and omnipod more than.
We report the accuracy in hypoglycemia of a new version of the dexcom san diego, ca g4 platinum cgm system software 505 and present results regarding the optimum setting of cgm hypoglycemic alerts. Patients will be able to go online and download the software, or they will receive the software preloaded onto their dexcom receiver with new orders, said terrence gregg, ceo, dexcom. Dexcom s continuous glucose monitor now with artificial pancreas algorithm. I already have a supply of g4 platinum sensors and a working g4 platinum transmitter.
The dexcom g4 platinum continuous glucose monitoring system is a glucosemonitoring device indicated for detecting trends and tracking patterns in persons age 2 and older with diabetes. Mard is the standard industry measurement of accuracy, where a lower mard reflects higher accuracy. Dexcom g4 platinum continuous glucose monitoring system. Dexcomg4 platinum cgm us market the continuous glucose. For help getting started with using your new dexcom cgm, or additional product training support, please call us at. Aug 01, 2015 this relationship depends on the distribution of sensor errors and appears to hold across various devices. This user guide is a comprehensive instructional resource on setting up and using the dexcom g4 platinum cgm system with share for pediatric patients. Software 505 is a further advancement g4 platinum and g4 platinum with sw 505 accuracy versus ysi by in. Dexcom software with artificial pancreas algorithm i am a. This study was designed to evaluate accuracy, performance, and safety of the dexcom san diego, ca g4 platinum continuous glucose monitoring cgm system g4p compared with the dexcom g4 platinum with software 505 algorithm sw505 when used as adjunctive management to blood glucose bg monitoring over a 7day period in youth. Page 22 for the software 505 study sw10505, 96% of systems provided between 1,497 and 1,992 valid glucose readings or more than 75% of the expected number of readings. Values from dexcom g4 platinum system with an advanced algorithm software 505 were plotted on the seg with temporally matched. The algorithm modification is referred to as software 505.
The dexcom g4 platinum continuous glucose monitoring system consists of the following components. Dexcomg4 platinum cgm us market the continuous glucose monitor of choice for diabetes management now with new software 505 introduced in october 2012, the dexcom g4 platinum cgm system has continued to impress both. Nov 10, 2014 dexcom is reporting that the mard mean absolute relative difference will increase by 4%. The system is intended for single patient use and requires a prescription. This latest software enhancement to the dexcom g4 platinum will. Dexcom g4 platinum cgm system with share pediatric user. But a cgm system will provide you with 247 glucose information to show you where it is at a certain moment and where it may be headed as well as how fast it. Dexcom g4 platinum system with software 505 software 505 study for detecting trends and tracking patterns when used as an adjunct to blood glucose testing in subjects with diabetes mellitus in. Singledigit mard demonstrated in software used in dexcom. Dexcom cannot guarantee the availability of dexcom g4 platinum and dexcom g5 mobile sensors beyond december 31st, 2020.
Retrospective analysis of continuous glucose monitoring data with. Find dexcom software downloads at cnet, the most comprehensive source for safe, trusted, and spywarefree downloads on the web. Thats mard of % in dexcom g4, compared to 9% in dexcom g5. New study dexcom g4 platinum w new software 505, 9%. Why wouldnt i want to download the new algorithm to my receiver to get better accuracy. The dexcom g4 platinum cgm system unveils what no meter can. The download is only available for users 18 years or older. Fda approves dexcom software with artificial pancreas algorithm dexcom announced today that the u. Diabeticdig, dexcom g4 platinum, new transmitter and software.
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