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.