Control-IQ Technology in the Real World: The First 30 Days

Lars Mueller,* Alexandra Constantin,^† Harsimran Singh,^† Steph Habif^†

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.

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Responsible Use of Control‑IQ Technology

Even with advanced systems such as Control-IQ technology, users 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 users 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. Because there are situations and emergencies that the system may not be capable of identifying or addressing, users 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. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Engl 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.

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Important Safety Information

The t:slim X2 insulin pump with Control-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Control-IQ technology, and a compatible continuous glucose monitor (CGM, sold separately). The t:slim X2 insulin pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in people requiring insulin. The t:slim X2 insulin pump can be used solely for continuous insulin delivery and as part of the System. When used with a compatible CGM, the System can be used to automatically increase, decrease, and suspend delivery of basal insulin based on CGM sensor readings and predicted glucose values. The System can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. The pump and the System are indicated for use in individuals 6 years of age and greater. The pump and the System are intended for single user use. The pump and the System are indicated for use with NovoRapid, Admelog, Trurapi, or Humalog U-100 insulin. The System is intended for the management of Type 1 diabetes.

Warning: Control-IQ technology should not be used by anyone under the age of 6 years old. It should also not be used in users who require less than 10 units of insulin per day or who weigh less than 25 kilograms.

The System is not indicated for use in pregnant women, people on dialysis, or critically ill users. Do not use the System if using hydroxyurea.

Users of the pump and the System must: be willing and able 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. If your CGM readings do not match your symptoms or expectations, use a blood glucose meter to make diabetes treatment decisions. The t:slim X2 pump must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.

Control-IQ Technology in the Real World: The First 30 Days

Objective

Method

Results

Conclusion

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Information

Disclosures