Time Above Range Improvements with Control-IQ Technology

Objective

To evaluate the effect of Control-IQ® technology on time in range (TIR) and time above range (TAR) in people with type 1 diabetes (T1D) who were not meeting the TAR targets (i.e. <25% of sensor glucose time >180 mg/dL and <5% of sensor glucose time >250 mg/dL).

Method

Sample included participants who were not meeting their TAR targets at Timepoint 1 (30 days pre-Control-IQ technology) and changes in their TIR and TAR outcomes at two subsequent timepoints along with patient-reported outcomes.

Results

With continued use of Control-IQ technology, participants demonstrated significant glycemic improvements alongside increase in device satisfaction and reduction in diabetes impact.

Conclusion

Use of Control-IQ technology demonstrated clinically valuable improvements in hyperglycemia and TIR outcomes in T1D participants who did not previously meet guideline TAR targets.

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Control-IQ Technology

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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. ‡ Willes Consulting Group, Inc. § As measured by CGM. ^ p = <.0001 (p-value is from a Wilcoxon signed-rank test).

References
Battelino T, Danne T, Bergenstal RM, et al. Clinical targets for continuous glucose monitoring data interpretation: Recommendations from the international consensus on time in range. Diabetes Care. 2019;42(8):1593-1603.
2. Marcovechhio ML. Complications of acute and chronic hyperglycemia. US Endocrinology. 2017;13(1):17–21.
3. Brown SA, Kovatchev BP, Raghinaru D, et al. Six-month randomized, multicenter trial of closed-loop control in type 1 diabetes. N Eng J Med. 2019;381(18):1701-1717.

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.