The Tandem t:slim X2™ insulin pump with Basal-IQ® technology predicts glucose levels 30 minutes ahead based on the last 4 consecutive CGM readings. Insulin delivery is suspended if the predicted sensor glucose (SG) is <80 mg/dL or if the observed SG is <70 mg/dL. Insulin delivery resumes as soon as SG begins to rise. The pivotal trial (PROLOG) showed 3 weeks of Basal-IQ® use reduced SG time <70 mg/dL by 31% compared to sensor-augmented pump.

De-identified data voluntarily uploaded to the t:connect® diabetes management application between August 30, 2018, and February 7, 2019, from individuals with diabetes who have used Basal-IQ® technology for 3, 6, and 9 weeks (N=4082, 2370, and 1307 respectively) were retrospectively analyzed. Real-world Basal-IQ® 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 (Table 1).

Basal-IQ® technology was found to be safe and effective in a real-world setting, with similar PLGS activation metrics as observed in PROLOG. Results showed the Basal-IQ® algorithm performs successfully at preventing hypoglycemia.

Disclosure

J.E. Pinsker: Research Support; Self; Ascensia Diabetes Care, Dexcom, Inc., Insulet Corporation, LifeScan, Inc., Roche Diabetes Care, Tandem Diabetes Care. Speaker’s Bureau; Self; Tandem Diabetes Care. K.N. Castorino: Consultant; Self; Abbott. Research Support; Self; Abbott, Dexcom, Inc., Drawbridge, Novo Nordisk Inc., Sanofi US. S.A. Leas: Employee; Self; Tandem Diabetes Care. S. Habif: Employee; Self; Tandem Diabetes Care.

Funding

Tandem Diabetes Care, Inc.

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