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  3. Significant Reduction in Time Below Range (Hypoglycemia) 

Objective

To determine how an advanced closed-loop system like Control-IQ® technology t:slim X2™ insulin pump can assist people with diabetes to better manage their time below range (TBR) targets while optimizing glycemic control.

Method

We examined sensor TBR metrics for people with with type 1 diabetes (T1D) 30 days prior to starting Control-IQ technology and after seven weeks of using Control-IQ technology, focusing on glycemic outcomes.

Results

Using Control-IQ technology, participants demonstrated significant reduction in both Level 1 (<70mg/dL) and Level 2 (<54mg/dL) hypoglycemia.

Conclusion

Use of the t:slim X2 pump with Control-IQ technology demonstrated clinically relevant reduction in hypoglycemia with improved sensor time in range in people with T1D within a few weeks.

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, 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.

* Design Lab, University of California San Diego.† Tandem Diabetes Care. ‡ As measured by CGM. 

References
1. de Galan BE, et al. Reducing the burden of hypoglycemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo-RESOLVE) project. Diabet. Med 2020;37(6):1066-1073.
2. Cryer PE. Severe Hypoglycemia Predicts Mortality in Diabetes. Diabetes Care. 2012;35(9):1814-1816
3. Gagnum V, et al. Causes of death in childhood-onset Type 1 diabetes: long-term follow-up. Diabet Med 2017;34(1):56–63
4. Cryer PE. Hypoglycemia: the limiting factor in the glycaemic management of Type I and Type II Diabetes. Diabetologia 2002;45:937–948.
5. Speight J, et al. Cognitive, behavioral, and psychological barriers to the prevention of severe hypoglycaemia: A qualitative study of adults with type 1 diabetes. SAGE Open Med 2014;2:2050312114527443
6. 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.

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.