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, 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. Since 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.

* 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

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 six 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, 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 six 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. The t:slim X2 pump and the CGM transmitter and sensor must be removed before MRI, CT, or diathermy treatment. Visit tandemdiabetes.com/safetyinfo for additional important safety information.