6 New Diabetes Products To Look For In 2017
If we learned anything about diabetes products in 2016, it’s that progress can happen faster than we anticipate. The diabetes community was stunned in September when the FDA announced that it had approved Medtronic Diabetes’ MiniMed 670G system, the world’s first pump/sensor system to be able to dose insulin on its own. (Advocacy works!) One of the most exciting things about the approval of Medtronic’s 670G is not only access to the groundbreaking device itself, but the path it paves for similar products – by many companies – to win approval as well. (We’re keeping an eye on Bigfoot Biomedical, Inc, the company that back in July of this year enrolled its first patients in a clinical trial for the Bigfoot smartloop automated insulin delivery system.) Now, as this year comes to a close, we’re listening to the buzz that continues to build around the new diabetes technology coming our way in 2017. The new year will bring a slate of highly anticipated products, including milestone devices like the OneTouch Via (a bolus-only delivery patch) and the above-mentioned Medtronic MiniMed 670G system (widely regarded as a rudimentary artificial pancreas). We’ve rounded up descriptions of some of the most exciting diabetes products expected to hit the market in 2017, followed by an approximate timeframe of when they’ll become available to the public. Sure, what we really want is a cure in 2017, but we’ll take improved quality of life, thanks to new devices and tech, with tremendous gratitude. Animas G5 Integrated Vibe Insulin Pump and CGM System What it is: This pump integrates Dexcom G5 technology with the Animas Vibe system. It’s especially exciting because it’s the only pump of its kind that is available to patients with type one diabetes as young as 2 ye Continue reading >>
Fda Approves Animas Onetouch Vibe Plus
Read Insulin Pump Helps Woman Escape Kidnapping. In late December 2016, Johnson & Johnson announced it had gained FDA approval for the (read carefully) Animas OneTouch Vibe Plus. Whats the major difference between the two systems? This insulin pump system is integrated with the Dexcom G5 CGM technology. Got that? The Vibe used the G4, and the Vibe Plus uses the G5. Dexcom had a similar kind of regulatory year in 2015, when it announced FDA approval for the G4 in January, and approval for the G5 in August of that year. As Diabetes Mine reported at the time of the G5 approval, the swiftness of FDA approval caught even Dexcom execs off-guard. Read The Pros and Cons of Pump Therapy. There are, of course, a lot of similarities between the Vibe and the Vibe Plus, which was also approved by Health Canada. Both have the selling point of being approved for use by children ages 2 and up, and both allow the ability to monitor glucose readings on the pump and on smartphone devices. The biggest difference is that Vibe Plus users dont have to carry a separate receiver for the CGM end of the technology. The Vibe Plus approval news allowed Johnson & Johnson to close out the year on a good news cycle. Earlier in the year, the company warned customers th at the OneTouch Ping was theoretically vulnerable to hacking, according to a Reuters report . A security firm had determined that a hacker standing within 25 feet of a pump user could trick the pump system into giving an insulin dose if the Ping was in a wireless setting. While such a risk was extremely low, it represented the first time that a medical device company warned customers of hacking risk. There have been no reports of similar concerns with the Vibe pump systems. A commercial release date for the Vibe Plus has not yet been se Continue reading >>
Animas® Vibe® Insulin Pump
Features It’s Dexcom CGM enabled. The Animas Vibe can now double as a continuous glucose monitor using Dexcom G4 PLATINUM sensor technology. The Dexcom G4 PLATINUM sensors are indicated for up to 7 days consecutive wear. The Transmitter for the Dexcom system is water resistant up to 2.4m for 24 hours.* The reading is updated on the pump every 5 minutes and you can see if your glucose is stable, rising or falling at a glance. More on the advantages of CGM and the Dexcom G4 Platinum. Subsidised access to Dexcom G5 Mobile and Dexcom G4 PLATINUM CGM sensors and transmitters is available through the NDSS to children and young people aged under 21 years, living with type 1 diabetes, who meet specific criteria. Visit www.ndss.com.au/CGM for more information today. We think a pump that’s waterproof just makes sense. Our pumps are tested and proven waterproof at 3.6 metres for up to 24 hours.† So you get uninterrupted insulin delivery while swimming or taking a bath, and peace of mind when you have unexpected contact with water. Fine-Tuned Insulin Delivery. The Animas Vibe Insulin Pump Swiss-made motor offers basal rate increments as low as 0.025 U/hr (available range of 0.025 to 25 U/hr) and bolus increments as low as 0.05 U across the available range (0.05 to 35 U) to deliver precise increments of insulin to help the body’s changing needs. Fully Customisable Food Database. With the download cable included free with your pump, you can use the web based Diasend software to easily create your own food database and upload into your pump. This means you don’t need to worry about remembering all the carbohydrate amounts in the food you eat – it’s all there at the touch of a button. The best part is you have complete control of the items in your database and only includ Continue reading >>
Dexcom G5 Cgm, Iphone, And Apple Watch: Your Questions Answered
Dexcom G5 CGM, iPhone, and Apple Watch: Your Questions Answered Dexcom released their highly-anticipated G5 continuous glucose monitor (CGM) for diabetes in September 2015. As the firstCGM (ever!) that transmits glucose data directly to the iPhone, theres been a lot of excitement about the revolutionary new device. Theres also been a LOT of questions, and weve collected official (and unofficial) answers to all of them. [divider]The Basics of the Dexcom G5 Mobile CGM System[/divider] 1.Whats the main difference between the Dexcom G5 and the G4 with Share? The G4 with Share was the first system to allow sugars to be displayed on an iPhone or Apple Watch, but this required thereceiver to be nearby. (Here, the iPhone is acting like another display to the receiver). TheG5s key difference is that the user no longer has to carry around theirreceiver, because the iPhone canfunction alone as a receiver. Keep in mind that both the G5 and G4 uses the exact same G4 sensor, but they have a different transmitter. (Confused yet? Hope this picture helps) 2. What are the subtle, more technical differences between the Dexcom G5 and G4 with Share? As described above, the onlydifference is a new transmitter that comes with the G5. (Confusingly, the G5 System ships with G4 sensors anda G4 with Share receiver.) This new G5 transmitter is just a tad thicker and transmits sugar readings viabluetooth tomultiple devices (such as an iPhoneandG4 receiver with Share). It also has a shorter lifespan (estimated at 3 months). The older G4 transmitter transmits via radio frequency toone device (must be a G4 receiver or G4 receiver with Share). The G4 transmitter is estimated to last 6 months. 2. If the G5 CGM doesnt need the Receiver, thenwhy does itstill come with a G4 Receiver with Share? The FDA in Continue reading >>
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- Practical Approach to Using Trend Arrows on the Dexcom G5 CGM System for the Management of Adults With Diabetes | Journal of the Endocrine Society | Oxford Academic
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First Impressions: Dexcom G5 Mobile.
Dexcom , Diabetes Advocacy , Psychosocial Support , Real Life Diabetes , Robot Life October 28, 2015 27 Comments Disclosure : I have a relationship with Dexcom that includes receiving my continuous glucose supplies at no cost. More details are outlined here on my disclosures page , but please know that the bias Im bringing to this is pretty significant, not simply because of the working relationship with Dexcom but also the fact that this CGM has been part of my diabetes care plan since 2006, so Im in deep for a dozen different reasons. If you have any questions, feel free to reach out . I received the G5 update about a month ago and didnt put it on until a few days ago. There are two reasons for that, the first being that my G4 transmitter was working just fine. No battery issues, no signal problems. It felt wrong to yank the transmitter and ditch it, particularly when you take the cost of these products into account. The second reason was because the G5 transmitter was a higher-profile (literally) piece of technology, sticking up a few extra millimeters higher than the slimmer profile G4. But a few weeks later, I did ultimately give the G5 a go, and am currently using the G5 Mobile platform now. These are my first impressions of the system (still on the first sensor, so not even seven days into things). Setting up the system took me longer than I had anticipated, but I suspect it is because I spent a lot of time updating my G4 receiver to work with the G5 system . I had to download software to my receiver, install updates, etc. and that took a while. That, and once my receiver was updated, the screen wasnt the black background with mellow colors, but was instead this BRIGHT WHITE OMG SCREEN that I could have used as a flashlight for my whole neighborhood, no problem. Continue reading >>
Why I'm Excited About Tandem's X2 Dexcom G5 Software Update - Taking Control Of Your Diabetes
Why Im excited about Tandems X2 Dexcom G5 software update In late August, the FDA approved Tandem Diabetes long-awaited first software update for their X2 Insulin Pump that enables Dexcom G5 integration. With a FREE simple software update performed in the comfort of their own home, thousands of X2 users can now display CGM data (from the Dexcom G5 Mobile System) directly on their Tandem pump screen. In the world of smartphone apps and hybrid closed loops, viewing CGM data on a pump screen might not appear at first glance to be groundbreaking, but Tandems software update will provide meaningful benefits not only for Tandem customers, but for the entire industry of people affected by diabetes. First time a software update has added a new feature to an insulin pump The pump that gets updated, not outdated is appropriately Tandems marketing slogan for their X2 Insulin Pump. A longstanding frustration for pump owners has been that insurance companies will not replace or upgrade most insulin pump hardware until the 4 yearwarranty period expires. Therefore, while you might be buying the latest and greatest pump on the market right now, it will likely be outdated within 18 months. By the time your 4 year warranty period expires, you might be two or three generations behind. And as we draw nearer to a fully closed-loop artificial pancreas, those two or three generations might make a huge difference. However, Tandems X2 platform has been built with the future in mind. People who received the very first X2 pumps nearly one year ago now have the same new Dexcom G5 integration available in the latest version shipping today with a simple convenient software update. Adding completely new features via software update has never been done in an insulin pump before. Tandem X2 is now the Continue reading >>
Premarket Approval (pma)
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. pump, infusion, insulin, to be used with invasive glucose sensor Approval for the OneTouch Vibe Plus System is indicated for continuous subcutaneous insulin infusion for the management of insulin-requiring diabetes. It can be used solely for continuous insulin delivery and as part of the OneTouch Vibe Plus System to receive and display continuous glucose measurements from the Dexcom G5 Sensor and Transmitter. The OneTouch Vibe Plus System's continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (ages 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results from the Dexcom G5 Sensor and Transmitter should be based on the trends and patterns seen with several sequential readings over time. The System is intended for single patient use and requires a prescription.The Animas Vibe Systems continuous glucose monitoring (CGM) is indicated for detecting trends and tracking patterns in persons (age 2 and older) with diabetes, and is intended to complement, not replace, information obtained from standard home glucose monitoring devices. CGM aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of results Continue reading >>
Insulin Pump Rundown
Choosing an insulin pump doesn’t have to be an overwhelming process. Should you go with a more traditional pump where you can monitor your insulin levels directly? Are you looking for a model that works with a BGM monitor and allows you to administer insulin via a remote? Maybe you need a pump that offers integration with a CGM system. What about size? Color? To use tubes or not to use tubes? Presenting the options so you can find out what pump best fits your lifestyle is our goal. So, with several models on the market, let us help you sort through the choices by taking a look at what’s available and breaking down the various features of each. We’ve separated the pumps into four categories: pumps that incorporate or work with a Blood Glucose Monitor (BGM) and offer Continuous Glucose Monitoring (CGM), pumps with just CGM capability, pumps with just a BGM, and standalone pumps that don’t work with a BGM or offer CGM. Hybrid Closed-Loop System The 670 G system is the newest member to the Medtronic pump family and the first hybrid closed-loop system. In other ways, it is a like a “basal modulator” where you have to still bolus but it predicts your basal rate. Every 5 minutes, the auto-mode option (hybrid closed-loop) automatically adjusts basal insulin delivery based on your sugar levels to keep you range. It is excellent at catching lows because it stops your insulin dosage 30 minutes before you reach your pre-selected low limits, then it will automatically restart insulin when your levels recover. Possible concerns: excessive alerts and extended menu that needs clearing. Only approved for ages 14+ because it has a total daily dose requirement of at least 8 units a day. Feeling of loss of control of management with closed-loop system. Pumps with BGM and CGM ca Continue reading >>
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The Animas® Vibe® Insulin Pump & Cgm System
3 In a clinical trial, the overall mean absolute relative difference (MARD) between sensor readings and YSI values was 13%. In other words, on average Dexcom G4® PLATINUM sensor readings and YSI readings differed by only 13%. From a study of 60 patients using the Dexcom G4® Sensor with a hand-held receiver first calibrated at 1-hour and then approximately every 12-hours following. Similar overall performance has been seen with 1-hour and 2-hour initial calibration. The transmitter and receiver used in the Dexcom G4® Sensor clinical trial were different than those used with the Animas® Vibe® system, but the Dexcom G4® Transmitter and Animas® Vibe® pump function similarly to the transmitter and receiver used in the trial but with a 2-hour initial calibration. The Animas® Vibe® Insulin Pump and CGM System is intended for the delivery of insulin and for continuous glucose monitoring (CGM) for the management of insulin-requiring diabetes. The Animas® Vibe® System’s CGM, which includes the Dexcom G4® PLATINUM Sensor and Transmitter, is indicated for detecting trends and tracking patterns in persons age 2 and older. The system is intended for single patient use and requires a prescription. Contraindications: Insulin pump therapy is not recommended for people unwilling or unable to test their blood glucose four to six times per day, unwilling or unable to see their healthcare professional regularly, or whose vision or hearing does not allow recognition of pump alerts, warnings, and alarms. The Animas® Vibe® Insulin Pump must be removed before MRI or CT scan, and the Dexcom G4® PLATINUM Sensor and Transmitter must be removed before MRI, CT scan, or diathermy treatment. Taking acetaminophen-containing medications while wearing the sensor may falsely raise sensor Continue reading >>
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Fda Approves First Insulin Pump Integrated With Dexcom G5 Mobile Continuous Glucose Monitor
Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada's authorization for the sale of the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for the treatment of patients age two and older living with diabetes. The OneTouch Vibe Plus is the first and only insulin pump integrated with Dexcom G5 Mobile CGM technology, combining accurate and precise insulin dosing technology from Animas with the most accurate CGM sensing technology from Dexcom. This system will enable patients to see their glucose reading at all times either on their pump or on using the Dexcom G5 App on their smart phone, and to deliver the precise amounts of insulin they may need from the pump. The Dexcom G5 Transmitter collects blood glucose readings from the Dexcom sensor and wirelessly sends them to the patient's OneTouch Vibe Plus Insulin Pump screen and compatible smart device using the Dexcom G5 Mobile System and app. This will enable patients using the pump and their caregivers to access CGM data wherever it is most convenient for them, and to make informed diabetes management decisions. In addition to the primary smart device, glucose data can be shared with up to five people utilizing the Dexcom Follow App. "People living with diabetes will no longer have to pull out their pump to read their glucose readings. By having constant access to glucose readings on their pump and now their smart devices, the OneTouch Vibe Plus will give people with diabetes greater flexibility and discretion," said Brian L. Levy, MD, FACE, Chief Medical Officer of JJDCC and Vice President of Worldwide Clinical Affairs for LifeScan Inc. "This unique connectiv Continue reading >>
Animas Vibe With Dexcom App
I recently got the Animas Vibe pump with the CGM Dexcom integrated. I know that the Dexcom alone has an app on your phone for you to view the blood sugars, but is there an app for the new Animas Vibe pump w/CGM? I recently got the Animas Vibe pump with the CGM Dexcom integrated. I know that the Dexcom alone has an app on your phone for you to view the blood sugars, but is there an app for the new Animas Vibe pump w/CGM? Why would you want one as your blood sugar is displayed on the pump? Why would you want one as your blood sugar is displayed on the pump? Because, although it shows up on my pump screen, I'm not constantly looking at it. As opposed to having an app, I'm using my phone more than I look at the pump, allowing me to see my blood sugars more often. I recently got the Animas Vibe pump with the CGM Dexcom integrated. I know that the Dexcom alone has an app on your phone for you to view the blood sugars, but is there an app for the new Animas Vibe pump w/CGM? In order to get the app to work on your phone, you still have to have the Dexcom receiver that has the 'share' in it. It would be nice if we could get rid of the receiver (I'm sure that will come eventually), but its really not a big deal to carry around the receiver in order for the receiver to transmit to the phone. So you can wear your vibe, leave the receiver in your pocket or purse, and never look at it... just look at the app on your phone. You will have to still calibrate the vibe AND the receiver, when you test your blood sugar. its really great having it on the phone, so discreet- no one ones you are checking your number! For me as a parent, its fantastic to be able to see my daughters numbers anywhere. As the diabetic, you now have 3 places to see your numbers: the vibe screen, the receiver, and Continue reading >>
Dexcom G4 Or G5 Mobile
Diabetes Forum The Global Diabetes Community Find support, ask questions and share your experiences. Join the community I am currently have an animas vibe pump and want to start using a CGM system. Any recommendation on if I should go for the G4 which uses the pump as the receiver or go for the G5 mobile and using my iPhone/watch as the receiver? Many thanks. Mike Have a word with @TorqPenderloin . It's my understanding he has used both G4/G5 systems and will explain the variants between the two, with regards to sensor life/transmitter life. @HighlandMike it's basically a cost/functionality trade off. With the G4, you can get the parts cheaper through Animas and if you want to use your phone, build the xDrip wireless bridge and use the NightScout infrastructure which you will have to build yourself. With the G5, you can use your phone, but it won't work with your Vibe, and the transmitters die every 3 months, so it costs quite a bit more. You will be able to buy the sensors through Animas (which will be cheaper), but not the transmitters, which you will have to buy direct from Dexcom. I am a G5 user, I love it. Dexcom have now started selling direct to the UK and sensor/ transmitter prices are a lot lower than AT offered. You also don't need to buy a starter pack if you buy from Dexcom, making initial startup cost cheaper with a G5 as you don't need a receiver (its nice to have though). Transmitter life sucks (3 months as @tim2000s mentioned) and can't be extended like the G4. But aside from that - amazing! Hi @HighlandMike , I use the G4, with an animas vibe and also have the receiver which I used before getting the pump. I haven't used the G5, but personally would not have gone for it, because of the transmitter life. The graph is a little less readable on the vibe, Continue reading >>
Dexcom G5® Mobile Continuous Glucose Monitoring
Discover Dexcom G5 Mobile Continuous Glucose Monitoring (CGM). Monitor your glucose on the go with the world’s first mobile-connected CGM system. The Dexcom G5 Mobile system gives you the freedom to view your glucose levels, trends and data from your compatible Android or Apple display devices. A Dexcom G5 Mobile Receiver can also be acquired as an optional display device. Better yet, with Dexcom G5 Mobile, you can eliminate the need for confirmatory fingerpricks, for daily glucose management decisions.* NEW! Animas and Dexcom CGM Introductory Offer – Contact us on 1300 851 056 or email [email protected] to get started. To order, please complete and return the Dexcom order form – you have the option of processing your payment online on our online shop The CGM Subsidised Initiative is here! The Australian Government is now providing access to fully subsidised Dexcom CGM products through the National Diabetes Services Scheme (NDSS). Subsidised access to Dexcom G5 Mobile and Dexcom G4 PLATINUM CGM sensors and transmitters is available through the NDSS to children and young people aged under 21 years, living with type 1 diabetes, who meet specific criteria. Visit www.ndss.com.au/CGM for more information today or visit our CGM Subsidy Initiative page for more information on your Dexcom options. Continue reading >>
Onetouch Vibe™ Plus Insulin Pump Earns Fda Approval And Health Canada License And Is First Pump Integrated With The Dexcom G5® Mobile Continuous Glucose Monitor
New system to enable exceptional glucose measuring accuracy and precise insulin delivery for even the most insulin-sensitive people with diabetes CHESTERBROOK, Pa., Dec. 20, 2016 /PRNewswire/ -- Animas Corporation, part of the Johnson & Johnson Diabetes Care Companies (JJDCC), announced today that it has received U.S. Food and Drug Administration (FDA) approval, and Health Canada's authorization for the sale of the OneTouch Vibe™ Plus Insulin Pump and Continuous Glucose Monitoring (CGM) System for the treatment of patients age two and older living with diabetes. The OneTouch Vibe™ Plus is the first and only insulin pump integrated with Dexcom G5® Mobile CGM technology, combining accurate and precise insulin dosing technology from Animas with the most accurate CGM sensing technology from Dexcom. This system will enable patients to see their glucose reading at all times either on their pump or using the Dexcom G5® App on their smart phone, and to deliver the precise amounts of insulin they may need from the pump. The Dexcom G5® Transmitter collects blood glucose readings from the Dexcom sensor and wirelessly sends them to the patient's OneTouch Vibe™ Plus Insulin Pump screen and compatible smart device using the Dexcom G5® Mobile System and app. This will enable patients using the pump and their caregivers to access CGM data wherever it is most convenient for them, and to make informed diabetes management decisions. In addition to the primary smart device, glucose data can be shared with up to five people utilizing the Dexcom Follow App. "People living with diabetes will no longer have to pull out their pump to read their glucose readings. By having constant access to glucose readings on their pump and now their smart devices, the OneTouch Vibe™ Plus will give Continue reading >>
Can Dexcom G5 And Animas Vibe Combine Data?
Can Dexcom G5 and Animas Vibe combine data? I am hoping for some help regarding collation of information from a number of different sources. I have a Dexcom G5 (use my iPhone as a receiver), an Animas Vibe pump. On my Vibe pump, I enter carb information and blood sugars so it can do the calculations for me. On my Dexcom G5 app, I only really enter when I exercise. I am aware the Dex app has the capability for one to enter dosage and carb info too. However, as I am already compelled to enter carb info on the Vibe, also entering this on the Dex app appears to me as doubling up. So in summary, is there a way to have the data from the Vibe and the Dexcom G5 in the same location, one data set superimposed upon the other? Preemptive thanks for any insights you may have! Unfortunately as far as I know, those of us in the US still cannot get our G5 data into Diasend without using the Dexcom receiver. I used to use my Dex receiver two weeks before my endo appointments so that I could combine my Vibe and G5 in the same report. I now use the Tandem X2 which is also not compatible with Diasend, although the original t:slim is. Diasend tech support thought that once you logged into your account, you could export the data into a Microsoft Excel spreadsheet under the share tab. So, the steps to compile Dexcom data and Vibe data that is in Diasend are: Step 1.) Make sure that both of your devices have the same date and time setting (or pretty close). Step 3.) Export data from Diasend and import it into an Excel spreadsheet. Step 4.) Export the Data from the Dexcom as a .csv and then import it into the same spreadsheet. @Tim35 I can already download my X2 to Diasend but obviously the CGM info is not yet included. @mohe0001 That is very interesting so I suppose I could give that a try. Continue reading >>
