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Objective

To examine real-world glycemic outcomes in a sample of early adopters of Control-IQ® technology on the t:slim X2™ insulin pump.

Method

Real-world t:connect® web application data was retrospectively analyzed of 1,659 individuals with type 1 and type 2 diabetes who had recently started using Control-IQ technology and uploaded at least 30 days of pre- and post-Control-IQ software update usage data to the t:connect web application from Tandem Diabetes Care by March 11, 2020.

Results

After 30 days of using Control-IQ technology, participants showed a 10% increase in median sensor time in range (TIR), from 68% to 78%. Improvements in sensor TIR were consistent across age groups. Sensor time >180 mg/dL showed a 10% decrease after 30 days of Control-IQ technology and 0.1% decrease of sensor time <70 mg/dL. Overall, participants showed a 96% median time in closed-loop automation.

Conclusion

Real-world data from early adopters of Control-IQ technology demonstrate significantly improved sensor TIR after 30 days of using this technology without increasing hypoglycemia (sensor time <70 mg/dL). TIR improvements based on reduced time in hypoglycemia and hyperglycemia, if maintained long-term, can help reduce the risk of diabetes-related complications.

Percentage of Time Sensor Spent in Range

Percentage of Time Sensor Spent in Range

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Responsible Use of Control-IQ Technology

Even with advanced systems such as the t:slim X2 insulin pump with Control-IQ technology, patients are still responsible for actively managing their diabetes. Control-IQ technology does not prevent all high and low blood glucose events. The system is designed to help reduce glucose variability, but it requires that patients accurately input information, such as meals and periods of sleep or exercise. Control-IQ technology will not function as intended unless all system components, including CGM, infusion sets and pump cartridges, are used as instructed. Importantly, the system cannot adjust insulin dosing if the pump is not receiving CGM readings. Since there are situations and emergencies that the system may not be capable of identifying or addressing, patients should always pay attention to their symptoms and treat accordingly.

* UC San Diego Design Lab Center for Health. † Tandem Diabetes Care.

References
1. Foster NC, et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016–2018. Diab Tech & Therap. 2019; 21(2).
2. Brown SA, et al. Sixmonth randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717.
3. Brown SA, et al. Clinical acceptance of the artificial pancreas: Glycemia outcomes from a 6-month multicenter RCT. 2019 ADA 79th Scientific Sessions, San Francisco, CA.
4. Beck RW, et al. Validation of time in range as an outcome measure for diabetes clinical trials. Diabetes Care. 2018; 42(3): 400-405.

Important Safety Information

RX ONLY. The t:slim X2 pump and Control-IQ technology are intended for single patient use. The t:slim X2 pump and Control-IQ technology are indicated for use with NovoLog or Humalog U-100 insulin.

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 people 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 t:slim X2 pump is indicated for use in individuals six years of age and greater. Control-IQ technology: 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 iCGM 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 six years of age and greater.

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, people on dialysis, or critically ill patients. Do not use Control-IQ technology if using hydroxyurea. Users of the t:slim X2 pump and Control-IQ technology must: 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. Visit www.tandemdiabetes.com/safetyinfo for additional important safety information.