New Artificial Pancreas: FDA Authorizes Tandem Diabetes Care Control-IQ Technology

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The U.S. FDA has authorized marketing of the Tandem Diabetes Care Control-IQ Technology, an interoperable automated glycemic controller device that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump and integrated continuous glucose monitor. This is the first such controller that can be used with other diabetes devices that are also designed to be integrated into a customizable diabetes management system for automated insulin delivery.

The t:slim X2 insulin pump with Control-IQ technology is an advanced hybrid-closed loop feature designed to help increase time in range (70-180 mg/dL), and the first system cleared to deliver automatic correction boluses in addition to adjusting insulin to help prevent high and low blood sugar. The system integrates with Dexcom G6 continuous glucose monitoring (CGM), which requires no fingersticks for calibration or diabetes treatment decisions. Control-IQ technology for the t:slim X2 insulin pump is the first automated insulin dosing software in a new interoperable automated glycemic controller category that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). This is the third category classified by the FDA for the interoperability of devices as a complete automated insulin dosing (AID) system.

All in-warranty t:slim X2 pump users in the United States will have the option to add the new feature free of charge via remote software update. The update is expected to be available by the end of January 2020, and new pumps with Control-IQ technology will begin shipping to customers in the same timeframe. The Company will continue to offer the t:slim X2 pump with Basal-IQ predictive low glucose suspend technology as an option for people who prefer a system designed specifically to help prevent lows.

The t:slim X2 insulin pump with Control-IQ technology uses CGM values, in conjunction with other variables such as insulin on board, to predict glucose levels 30 minutes ahead and adjust insulin delivery accordingly. If glucose values are predicted to drop below 112.5 mg/dL, basal insulin delivery is reduced, and when predicted to be below 70 mg/dL, basal insulin delivery is stopped. If glucose values are predicted to be above 160 mg/dL in the next 30 minutes, basal insulin will be increased. If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL, and delivers 60 percent of that value up to once an hour as needed. Control-IQ technology also offers optional settings for sleep and exercise that will change the treatment values to better match the different physiologic needs during these activities.

 

Benefits of Control-IQ Advanced Hybrid Closed-Loop Technology:

  1. Predicts and helps prevent lows and highs – Control-IQ technology uses CGM readings to predict glucose values 30 minutes ahead and can increase, decrease or stop basal insulin delivery to help keep glucose in range (70-180 mg/dL).
  2. Automatic Correction Boluses – If glucose values are predicted to be above 180 mg/dL, Control-IQ technology calculates a correction bolus with a target of 110 mg/dL and delivers 60 percent of that value. It will do this up to once an hour as needed.
  3. Accommodates for sleep and exercise – Control-IQ technology offers optional settings for sleep and exercise that change the treatment values to better match the different physiologic needs during these activities.
  4. No fingersticks – With Dexcom G6 CGM integration, the Control-IQ feature works with no fingersticks required for mealtime dosing or calibration. Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking, and the ability to share real-time CGM data with up to 10 followers.
  5. Easy to use – The system has no complicated criteria to keep Control-IQ technology on. If the CGM signal is temporarily lost, the Control-IQ feature will resume automatically when the CGM is back in range. In the pivotal study, participants gave Control-IQ technology a 4.7 out of 5.0 for ease of use, and a 4.8 out of 5.0 for desire to continue use of the system.

 

Standard Features of the t:slim X2 Insulin Pump:

  1. Color touchscreen – The large color touchscreen on the t:slim X2 pump is easy to read, simple to learn, and intuitive to use for anyone familiar with a smartphone or tablet.
  2. Small and discreet – The t:slim X2 pump is up to 38 percent smaller than other pumps, yet can hold up to 300-units of insulin.
  3. Can be used with or without the Control-IQ feature or CGM – When advanced features are turned off, the t:slim X2 pump removes the CGM chart from the screen and puts the Bolus and Option buttons front and center for easy access.
  4. #1-rated customer support – Tandem Diabetes Care customer support has been consistently ranked number one by pump users in independent patient surveys since 2013.

For additional product and safety information, or to begin the order process, visit http://tandemdiabetes.com/controliq

Free Demo App – Control-IQ Technology

Tandem’s free t:simulator™ App lets people experience the touchscreen interface of the t:slim X2 pump with Control-IQ technology directly on a mobile device. For more information and to download the app, visit http://www.tandemdiabetes.com/tsimulator.

Free Software Update for Current t:slim X2 Pump Users

All in-warranty t:slim X2 pump users in the United States will have the option to update their pumps with the Control-IQ feature free of charge via a software update using a personal computer. The Control-IQ feature update will require a user to secure a new prescription from his or her healthcare provider and complete an online training module. Internet and computer access are required for pump updates. All eligible t:slim X2 pump users will receive an email with more information on the update process in the coming days. Tandem expects the Control-IQ software update to be available for current t:slim X2 pump by the end of January 2020. Information about the requirements and update process is available at www.tandemdiabetes.com/X2update.

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