Jordan E. Pinsker,* Kristin N Castorino,* Scott A Leas,† Stephanie Habif†
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.
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.
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).
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.
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Learn More* 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.