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Objective

To determine real-world effects of the t:slim X2™ insulin pump with Basal-IQ® technology on hypoglycemia outcomes as compared to the results from the PROLOG (PLGS for Reduction of Low Glucose) pivotal trial.

Method

De-identified data voluntarily uploaded to the t:connect® web application (between August 30, 2018 and February 7, 2019) from individuals with diabetes who had used Basal-IQ technology for 3, 6, and 9 weeks were retrospectively analyzed. Real-world Basal-IQ technology hypoglycemia outcomes were compared to the PROLOG results.

Results

After 3 weeks of real-world use, median time SG <70 mg/dL was 1.0% overall (1.0% daytime and 0.9% nighttime) vs. 2.6% (2.4% daytime and 2.7% nighttime) in PROLOG. Median time with SG <60 was 0.3% and time <50 mg/dL was 0.1%, vs. 0.9% and 0.2% in PROLOG. After 6 and 9 weeks, median time SG <70 mg/dL was 1.1%. Number of insulin suspensions and suspension duration were similar to PROLOG. Mean sensor glucose at suspension was also the same (104mg/dL).

Conclusion

Basal-IQ technology was found to be safe and effective in a real-world setting, with similar PLGS activation metrics as observed in PROLOG. Overall system performance was excellent, with only 1.0% overall hypoglycemia rate at 3 weeks of use.

t:slim X2 Insulin Pump with Basal-IQ Technology

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Responsible Use of Basal-IQ Technology

Systems like the t:slim X2 insulin pump with Basal-IQ technology are not substitutes for the active management of diabetes. There are common scenarios in which automated systems cannot prevent a hypoglycemic event. The Basal-IQ feature relies on current CGM sensor readings to function and will not be able to predict glucose levels and suspend insulin delivery if a patient’s CGM is not functioning properly or his/her pump is unable to receive the CGM signal. It’s recommended your patient always uses the components of the pump system (pump, cartridges, CGM, and infusion sets) according to the applicable instructions for use and checks them regularly to make sure they are functioning as expected. Patients should always pay attention to their symptoms, actively monitor and manage glucose levels, and treat according to your recommendations.

* Sansum Diabetes Research Institute, Santa Barbara, CA. † Tandem Diabetes Care, San Diego, CA.

References:
1. Forlenza GP, Wadwa RP, Slover R, et al. Inpatient Safety and Feasibility of the Tandem Predictive Low Glucose Suspend (PLGS) Insulin Pump System. Diabetes. 2017; 66(Supplement 1):A78.
2. Forlenza GP, Li Z, Buckingham BA, et al. Predictive Low Glucose Suspend Reduces Hypoglycemia in Adults, Adolescents, and Children with Type 1 Diabetes in an At-Home Randomized Crossover Study: Results of the PROLOG Trial. Diabetes Care. 2018;41(10):2155-2161.
3. Pinsker JE, Li Z, Buckingham BA, et al. Exceptional Usability of Tandem t:slimX2 with Basal-IQ Predictive Low Glucose Suspend (PLGS): The PROLOG Study. American Diabetes Association, Orlando, FL, June 2018. Diabetes. 2018;67(Supplement 1):86-LB.
4. Patient-Reported Outcomes. Data on File. Tandem Diabetes Care, Inc.

Important Safety Information

Caution: Federal (USA) law restricts the t:slim X2 insulin pump and the t:slim X2 insulin pump with Basal-IQ technology to sale by or on the order of a physician. The t:slim X2 insulin pump with Basal-IQ technology (the System) consists of the t:slim X2 insulin pump, which contains Basal-IQ technology, and a compatible integrated continuous glucose monitor (iCGM, 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 t:slim X2 insulin pump with Basal-IQ technology can be used to suspend insulin delivery based on CGM sensor readings. 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 patient use. The pump and the System are indicated for use with NovoLog or Humalog U-100 insulin. The System is not indicated for use in pregnant women, people on dialysis, or critically ill patients. 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. The t:slim X2 pump, transmitter, and sensor must be removed before MRI, CT, or diathermy treatment. For additional important safety information, visit www.tandemdiabetes.com/safetyinfo.