Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology | Business WireWe are taking very seriously the current COVID-19 pandemic and have taken steps to protect the health, safety and well-being of our customers, employees and communities We are taking very seriously the current COVID-19 pandemic and we have taken steps to protect the health, safety and well-being of our clients, employees and communities. Cookie policy This website uses cookies to help us give you the best experience when visiting. By using this website you agree to our use of these cookies. Learn more about how we use cookies and how to manage them Easy to use Tandem offers a variety of products designed to be easy to use and flexible enough to meet a wide variety of individual needs and lifestyles. Diabetes is all we do In Tandem Diabetes Care, our reason to be is to make the lives of people with diabetes better and better, through implacable innovation. t:slim X2 Insulin pumpEasy to use. Easy to love. Get rid of multiple injections daily and enjoy more freedom to manage your diabetes with the insulin pump t:slim X2. The elegant design of this pump is combined with a series of advanced features that you would expect on a modern device. The beauty of the insulin pump t:slim X2TM is that it is up to 38% smaller than other pumps1, but it can contain a surprisingly large amount of insulin (up to 300 units). With its color touchscreen, the X2 t:slim pump is also easy to read and intuitive to use for anyone familiar with a smart device. The option is easyThe X2 t:slim pump can be used as an independent insulin pump, or it can be integrated with the Dexcom G6* continuous glucose monitoring system (CGM). When used with CGM, you can choose one of the two predictive technologies that help deliver insulin, which makes it easier to manage diabetes. Control-IQ TechnologyControl-IQTM advanced hybrid closure technology adjusts insulin delivery to help prevent high and low, while allowing the user to manually operate for meals. Basal-IQ Technology Basal-IQ® technology predicts and helps reduce the frequency and duration of low-tail events. This simple to use system works at the bottom without a constant input. Remote Software Updates The insulin pump t:slim X2 is the first clean insulin pump of the FDA capable of remote features updates.† Using a personal computer, patients can keep their pump up to date with the latest technology during their warranty period. Reporting made simple With just a few touches on the T:slim X2 insulin pump, you can see your insulin delivery and your glucose history. You can also upload the data from the t:slim X2 insulin pump wirelessly through the t:connect® mobile app to remove the need to connect the pump in the doctor's office. ‡ Automatic correction BolusesControl-IQ can offer automatic correction bolts,† a first for automated insulin delivery devices, to help address unpredictable and sometimes fluctuating insulin needs children to face throughout the day. Other Powerful Features Zero fingersWhen integrated with Dexcom G6 CGM§ Rechargeable batteryInconvenient charge through micro-USB Large color touchscreen port Easy to read, simple to use interface Custom settingsCreate up to six Personal Profiles Hermetic construction 3-foot-fitted construction for 30 minutes (IPX7) Bluetooth® Wireless technology Modern connectivity for a modern world A free virtual pump demo The t:simulatorTM application allows you to test the easy drive use the tactile screen interface of the insulin t:slim X2TM pump using your smartphone or tablet. Responsible Control‐IQ Technology Even with advanced systems such as the T:slim X2 insulin pump with Control-IQ technology, you are still responsible for actively managing your diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce the variability of glucose, but requires accurate information such as meals and sleep periods or exercise. Control-IQ technology will not work as desired unless you use all system components, including your CGM, infusion assemblies and pump cartridges, as indicated. Importantly, the system cannot adjust the insulin dose if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be able to identify or address, always pay attention to your symptoms and deal with your health care provider's recommendations. Responsible Basal-IQ Technology Systems such as the T:slim X2 insulin pump with Basal-IQ technology are not substitutes for active diabetes management, as there are common scenarios in which automated systems cannot prevent hypoglycemia. The Basal-IQ function is based on continuous readings of CGM and may not predict glucose levels and suspend insulin delivery if your CGM does not work properly or cannot communicate with your pump. Be sure to always use your pump, cartridges, CGM and infusion assemblies as instructed and checked regularly to make sure they are working properly. Always pay attention to your symptoms, actively monitor your glucose levels and treat according to your health care provider's recommendations. ♪ Dexcom CGM is sold separately. The transmitter can only be paired with a medical device (either a Dexcom or t:slim X2 insulin pump) and a consumer device (telephone) or tablet) at the same time. † Additional updates are currently not available for the T:slim X2 insulin pump with Control-IQ technology and are subject to regulatory approvals. Future updates for some or all Tandem products may not be developed and cannot be offered everywhere. Software updates are only available to customers who are in warranty when updating your pump, and may require an additional recipe and training. The charges can be applied. Tandem can discontinue selecting software and features over time at your discretion. . Information about the t:connect mobile app display may not be identical to the current status of your pump. Wireless loads from the t:connect mobile app to the cloud-based t:connect web application require a compatible phone and a wireless Internet connection. Downloads to the web application t:connect do not take place in real time and should not be trusted by healthcare providers or caregivers for remote patient monitoring. Standard carrier data rates can be applied. † Users should continue to fight for meals and actively manage their diabetes. If glucose values are predicted above 180 mg/dL, the Control-IQ technology calculates a correction bolt using the Personal Profile settings and a target of 110 mg/dL and delivers 60% of that value. A Automatic Correctional Bolus will not occur within 60 minutes of a bolt that has been delivered or cancelled. § Zero fingersticks required when using the X2 t:slim pump with the integration of Dexcom G6 continuous glucose monitoring (CGM). If glucose alerts and CGM readings do not match symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. References 1. 38% lower than MiniMed 630G and 670G and at least 28% lower than MiniMed 530G, Animas Vibe and Omnipod System. Data in the file, Attention of Tandem Diabetes. Important safety information RX SOLO. The insulin pump t:slim X2, Basal-IQ technology and Control-IQ technology are intended for a unique use of patients. The pump t:slim X2, the Basal-IQ technology and the Control-IQ technology are indicated for insulin use NovoLog or Humalog U-100. t: thin X2 insulin pump: Insulin pump t:slim X2 with interoperable technology is an enabled alternative controller pump (ACE) that is intended for the subcutaneous delivery of insulin variables, diabetes melli The pump is able to communicate reliable and securely with digitally-connected compatible devices, including automated insulin dosing software, to receive, execute and confirm commands of these devices. The pump is indicated for use in individuals six years old and older. Basal-IQ technology: Basal-IQ technology is intended to use it with a compatible, integrated glucose monitor (iCGM, sold separately) and an ACE pump to automatically suspend the delivery of insulin based on iCGM readings and predicted glucose values. The Pern Calculator is indicated for managing diabetes by people with diabetes by calculating an insulin dose or intake of data-based carbohydrates introduced by the user. Basal-IQ technology is intended for managing diabetes mellitus in people over six years of age. Control-IQ Technology: Control-IQ technology is intended to use with an iCGM pump (sold separately) and ACE to automatically increase, decrease and suspend the delivery of basal insulin based on iCGM readings and predicted glucose values. You can also deliver the correction screws when it is predicted that the glucose value exceeds a predefined threshold. IQ-control technology is intended for the management of type 1 diabetes mellitus in people over six years of age. WARNING: Control-IQ technology should not be used by anyone under the age of six. Nor should it be used in patients requiring less than 10 insulin units per day or weighing less than 55 pounds. WARNING: Control-IQ technology should not be used by anyone under the age of six. Nor should it be used in patients requiring less than 10 insulin units per day or weighing less than 55 pounds. IQ-control technology and Basal-IQ technology are not indicated for use in pregnant women, dialysis people or patients with critical disease. Do not use Control-IQ technology if you use hydroxyurea. X2 t:slim pump users, Basal-IQ technology and Control-IQ technology should: be able and willing to use the insulin pump, CGM and all system components according to their respective instructions of use; test blood glucose levels as recommended by your healthcare provider; demonstrate the appropriate skills for carbohydrate detection; maintain sufficient skills for diabetes; see providers and medical care; The t:slim X2 pump, transmitter and sensor should be removed before the magnetic resonance treatment, computed tomography or diathermia. Visit for additional important security information. t:connect mobile app: The mobile app t:connect is intended to be a secondary screen for compatible insulin pumps of the Diabetes Tandem and is able to load data from the pump wirelessly that it receives in the web application t:connect. The t:connect mobile app is not meant to control an insulin pump and is not meant to be a replacement of the information displayed in your insulin pump. Dosage decisions should not be made based on the secondary display device. The user should follow instructions on the continuous monitoring system of glucose and insulin pump. This secondary display device is not intended to replace self-monitoring practices as advised by a doctor. Dedicated to improving and improving the lives of people with diabetes, through incessant innovation and the client's revolutionary experience. © 2021 Diabetes tandem Care, Inc. All rights reserved. About TandemTerms and Policies Stay logged in© 2021 Diabetes tandem Care, Inc. All rights reserved.
t:slim X2TM Insulin pump with Basal-IQ technologyPredicted and helps prevent lows with ZERO heads* When life gets busy, the fear of coming down can really get in its way. Our Basal-IQ predictive low-end suspension technology can help you spend less time worrying about the bass and longer living your life. The T:slim X2 insulin pump has a slender and elegant design and is the only available pump that is compatible with that indicated to make treatment decisions without a finger. *Tandem t:slim X2 The insulin pump is fully funded for eligible patients through Pharmac. For more information or to buy, contact NZMS Diabetes in or Update Basal-IQ Request a small demonstration pump. Great features. So simple and so thinThe t:slim X2 Insulin Pump was designed to be easy to use. Touch screen technology makes the t:slim X2 Insulin Pump simple to learn and simple to use. The beauty of the t:slim X2 Insulin Pump is that it has a slender and elegant design but can contain a surprisingly large amount of insulin – up to 300 units. All thanks to our Micro-delivery® technology and an innovative design of flat insulin cartridges. Rechargeable and durable The rechargeable battery of the t:slim X2 Insulin Pump can be loaded from a wall output, the car, a power pack or a computer without interrupting insulin delivery. A charge lasts up to 7 days, so there is no need to worry about buying extra batteries! The insulin pump t:slim X2 is also ultra-strong: the case of aluminum is durable and lightweight. The touch screen is made of high quality glass and disintegration resistant. In addition, the t:slim X2 Insulin Pump is hermetic,2 so there is no need to worry about accidentally getting wet. Simple to customize Create up to 6 different personal profiles, and within each profile, create up to 16 different time segments that allow individual basal rates, insulin to carbohydrates ratios, correction factors and blood glucose levels. Profiles can be named individually so it is easy to know which one to use! Responsible insulin delivery Basal-IQ® technology predicts and helps prevent lows. You can activate and turn off insulin delivery as often as every 5 minutes. There is no minimum period of insulin suspension. It works quietly in the background There are no additional alerts or alarms beyond the standard continuous monitoring of glucose (CGM) and pump notifications.* Users should only decide whether they want the function to turn on or off. How Basal-IQ Works Basal-IQ function helps reduce the frequency and duration of low glucose events by predecensing glucose levels 30 minutes ahead and suspending insulin if they are expected to fall below 4.4 mmol/L, or if a CGM reading falls below 3.9 mmol/L.t:slim X2 Insulin Pump Specifications General specifications Weight 112 grams (with 300-unit cartridge) Insulin Up to 300 units For use with fast-acting insulin U-100 Watertight Tested up to 1 meter for 30 minutes (IPX7 class) Alarms Adjustable volume, visual, vibratory Alerts/Reminders High BG (blood glucose), low BG, after Bolus BG, Lost of flesh Bolus, Reminder of site change Personal profiles 6 customizable profiles Scheduled adjustments 16 time settings per personal profile Adjustment rate, correction factor, ratio carb, target BG Duration of insulin From two to eight hours in increments per minute Baseline rate 0.1 - 15 units/hr Increases: 0.001 units Bolus Range: 0.05 - 25 units Increases: 0.01 unit CGM Integration Dexcom G6 System FAQ For additional resources, visit our NZMS diabetes or contact her. The t:slim X2 Insulin Pump is compatible with the t:lock cartridge and the following t:lock infusion assemblies: AutoSoftTM 90, AutoSoftTM 30, TruSteelTM. Both infusion assemblies and cartridges are available through their local Pharmacy and in our . Your pump has a limited warranty of 4 years from the date of the original retail purchase. The insulin pump t:slim X2 and consumables are now fully funded for eligible patients. For more information on pharmacy funding for t:slim X2 Insulin pump To find out if you qualify for funding, please talk to your diabetes health care team. Please visit our insulin pump accessories t:slim X2. NZMS Diabetes provide 24/7 technical support for your t:slim X2 Insulin Pump, as well as CGM Systems. NZMS Diabetes has a free loan plan for those occasions, call us to book on a spare pump in Our Technical Support Number also works from abroad: +61 2 9882 3105 (please note that it is not a free toll number)The Tandem pumps and cartridges are only indicated for use with insulin Novolog and Humalog U-100. The safety and efficiency of other insulins, including Fiasp, have not been established for use with Tandem pumps. Importantly, clinical trials using our automated insulin delivery algorithms were only performed using Humalog and Novolog U-100 insulins, which have different appearance times compared to Fiasp. Tandem pumps and cartridges are only indicated for use with Novolog and Humalog U-100 insulins. Importantly, clinical trials using our automated insulin delivery algorithms were only performed using Humalog and Novolog U-100 insulins, which have different appearance times compared to Fiasp. If you use Fiasp in your pump and start experiencing persistent problems that can be attributed to insulin compatibility, we cannot guarantee that your warranty will be honored. Video Watch the video to learn more about the t:slim X2 Insulin Pump! Important Risk References and Information Basal-IQ technology is not a substitute for the active self-management of your diabetes. Please see the rear deck for more information.* If your glucose alerts and readings do not match your symptoms or expectations, they make a finger to confirm your blood glucose level. 1.No additional updates are currently available for the t:slim X2 Pump with the integration of Dexcom G5 Mobile CGM and are subject to future regulatory approvals. The charges can be applied. 2.Tested up to 1 metre for 30 minutes (IPX7 rating).* CGM-based treatment requires calibration finger; it may result in hypoglycemia if calibration is not performed, when paracetamol is taken, or if symptoms/expectations do not match CGM readings. If symptoms persist, please contact your health care professional. † The Dexcom G5 Mobile The CGM transmitter can only be paired with a medical device (either a Dexcom receiver or t:slim X2 insulin pump) and a compatible mobile device (telephone or tablet) at the same time. This application is only for demonstration purposes and is not identical to the functionality of the t:slim X2 Insulin Pump. It should not be used for therapy decisions. To see which smart devices are compatible with the t:simulator application, see the full application list in The App Store and Google Play. ^See your healthcare professional to see what product is suitable for you. Stay informed with Diabetes NZMS You can now get all the latest news and updates of our products, events and resources directly into your inbox. Something went wrong. Please try it later! Send NZMS Diabetes a message We are always happy to help, send us a message or a question We have received your request and we will be in contact by email soon. Shopping cart Your cart is emptyHeat pad Professional LoginEnter or register to access restricted resourcesSign up now
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