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Objective

To compare real-world glycemic outcomes between individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D) from a sample of early adopters of the t:slim X2™ insulin pump with Control-IQ® technology.

Method

The retrospective study included both T1D and T2D individuals who had recently updated their insulin pump software to initiate use of Control-IQ technology. Analysis included at least 14 days of pre- and 14 days of post-Control-IQ technology usage data that participants had uploaded to the t:connect® web application as of March 11, 2020.

Results

In the T1D subgroup (n=2,896), participants showed an increased sensor time in range, reduced time in sensor glucose <70 mg/dL, and reduced time in sensor glucose >180 mg/dL. In T2D subgroup (n=144), participants showed significant increase in sensor time in range and reduced time in sensor glucose >180 mg/dL. There was no change in time in sensor glucose <70 mg/dL. During 14 days of using Control-IQ technology, both T1D and T2D participants recorded 96% time in closed-loop automation.

Conclusion

These early results from the use of Control-IQ technology showed valuable improvements in time in range (based on sensor glucose values) and other glycemic variables for people with T1D and T2D. Improved sensor time in range, 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.

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

References:
1. Reznik Y, et al. Insulin Pump for Type 2 Diabetes: Use and misuse of continuous subcutaneous insulin infusion in type 2 diabetes. Diabetes Care. 2013; 36(Supp 2): S219-S225.
2. Singh P, et al. Insulin Pump in Difficult to Control Type 2 Diabetes: A Single Center, Five Years’ Experience. Cureus. 2018;10(8):e3240.
3. Brown SA, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717.
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.