Tandem Diabetes Care Announces FDA Clearance of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology
Automated Insulin Dosing Software First to Receive New Classification by
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The t:slim X2 insulin pump with Control-IQ technology from
All in-warranty t:slim X2 pump users in
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.
With the interoperable automated glycemic controller designation, the
More information on the new interoperable automated glycemic controller classification can be found in the press release issued by the
“Not only do new closed-loop systems need to be effective at improving glycemic control, they must also be easy to understand and use so patients can experience the full benefits of the technology. The t:slim X2 insulin pump with Control-IQ technology successfully achieved both objectives in the clinical studies,” said
“With this clearance, we will be launching the most advanced automated insulin dosing system commercially available in the world today,” said
“The approval of the Control-IQ system with Dexcom G6 CGM brings together two incredible products to deliver a powerful automated insulin dosing solution for people with diabetes,” said
Benefits of Control-IQ Advanced Hybrid Closed-Loop Technology:
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).1
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.
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.
No fingersticks – With Dexcom G6 CGM integration, the Control-IQ feature works with no fingersticks required for mealtime dosing or calibration.2 Other benefits of the Dexcom G6 CGM include an extended 10-day wear, acetaminophen blocking6, and the ability to share real-time CGM data with up to 10 followers.7
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.8
Standard Features of the t:slim X2 Insulin Pump:
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.
Small and discreet – The t:slim X2 pump is up to 38 percent smaller than other pumps9, yet can hold up to 300-units of insulin.
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.
#1-rated customer support –
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
Control-IQ Technology – Clinical Outcomes
Data from the NIH-funded DCLP3 study, published by the
Important Safety Information for the t:slim X2 Insulin Pump with Control-IQ Technology
Caution: Federal (
Indications for Use:
t:slim X2 insulin pump
The t:slim X2 insulin pump with interoperable technology is an alternate controller enabled (ACE) pump that is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The pump is indicated for use in individuals 6 years of age and greater. The pump is intended for single patient, home use and requires a prescription. The pump is indicated for use with
Control-IQ technology is intended for use with a compatible integrated continuous glucose monitor (iCGM, sold separately) and ACE pump to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. Control-IQ technology is intended for the management of Type 1 diabetes mellitus in persons 14 years of age and greater. Control-IQ technology is intended for single patient use. Control-IQ technology is indicated for use with
Contraindications and Warnings:
BOXED WARNING: Control-IQ technology should not be used by anyone under the age of six years old. It should also not be used in patients who require less than 10 units of insulin per day or who weigh less than 55 pounds.
Control-IQ technology is not indicated for use in pregnant women, persons on dialysis, or critically ill patients.
Users of the t:slim X2 pump and Control-IQ technology must:
- be able and willing to use the insulin pump, CGM, and all other system components in accordance with their respective instructions for use;
- test blood glucose levels as recommended by their healthcare provider;
- demonstrate adequate carb-counting skills;
- maintain sufficient diabetes self-care skills;
- see healthcare provider(s) regularly; and
- have adequate vision and/or hearing to recognize all functions of the pump, including alerts, alarms, and reminders;
The t:slim X2 pump, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. For additional important safety information, visit tandemdiabetes.com/safetyinfo.
Insulin Pump Use and Diabetes
Diabetes is a chronic, life-threatening disease that affects more than 29 million people in
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements relate to, among other things, the anticipated timing for the commercial launch of the t:slim X2 pump with Control-IQ technology and our ability to offer the Control-IQ software update for current t:slim X2 pump users. These statements are subject to numerous risks and uncertainties, including our ability to commence commercial scale manufacturing of the t:slim X2 pump with Control-IQ technology, our ability to operate and maintain a system to facilitate online training and prescription handling for existing t:slim X2 pump customers upgrading their existing devices, and the risk that we may encounter other challenges that may delay the commercial launch of t:slim X2 pump with Control-IQ technology, as well as other risks identified in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, and other documents that we file with the
1 As measured by CGM
2 If glucose alerts and CGM readings do not match symptoms or expectations or if taking over the recommended maximum dosage amount of 1000mg of acetaminophen every 6 hours, use a blood glucose meter to make diabetes treatment decisions.
3 Dexcom G6 CGM sold separately
4 The Dexcom G6 CGM transmitter can only be paired with one medical device (either a
5 A new prescription and additional training are required for this software update.
6 Dexcom G6 CGM readings can be used to make diabetes treatment decisions when taking up to a maximum acetaminophen dose of 1,000mg every 6 hours. Taking a higher dose may affect the G6 readings.
7 Separate Follow App required.
9 38 percent smaller than MiniMed 630G and 670G and at least 28 percent smaller than MiniMed 530G, Animas Vibe and Omnipod System. Data on file,
10 dQ&A USA Diabetes Connections Surveys, 2013-2019