Introduction & Objective: People with diabetes frequently miss mealtime insulin boluses. The t:slim X2 pump with Control-IQ technology (CIQ) delivers automatic correction insulin, which is thought to help improve glycemia when users do not consistently bolus for meals. This study uses simulations of a virtual population representative of CIQ users to evaluate the benefits of CIQ for users who do not bolus for small or moderate meals, as compared to those on multiple daily injections (MDI).
Methods: We leveraged 500,000 user years of real-world CGM, pump, and behavior data from over 420,000 customers to develop Tandem’s Statistical Simulator (TSS). TSS includes statistical models of user and population physiologies, behaviors, aleatory uncertainty, and CIQ system components. It can be used to run in silico clinical trials on populations representative of CIQ users in the real world. The TSS was used to compare glycemic outcomes for a group of 1000 virtual users under 4 scenarios: MDI vs. CIQ when bolusing for every meal, and CIQ vs MDI when not bolusing for small/moderate sized meals (≤40g carbs).
Results: Virtual MDI subjects who bolused for every meal had a median (IQR) of 58% (26-76%) TIR and 0.9% (0.2-2.3%) TBR. These same virtual subjects using CIQ who bolused for every meal had 69% (58-79%) TIR and 0.7% (0-3%) TBR. Virtual MDI subjects who did not bolus for meals ≤40 g of carbs had a 14% (2-37%) TIR and 0.1% (0-0.8%) TBR. These same virtual subjects using CIQ had 63% (53-71%) TIR and 0.6% (0.1-1.9%) TBR under same conditions.
Conclusion: CIQ significantly improves TIR regardless of bolus scenario, but is especially effective for individuals who miss boluses for moderate meals (more than tripling TIR). This suggests that MDI users who are prone to missing boluses would benefit greatly from CIQ use even if they continued not to bolus or count carbs accurately. This further provides evidence in line with ADA guidelines 2024 that diabetes technology should be offered to everyone (and not just the “best” candidates).
L. Fu: None. A. Trahan: Employee; Tandem Diabetes Care, Inc. L.H. Messer: Employee; Tandem Diabetes Care, Inc. A. Constantin: Employee; Tandem Diabetes Care, Inc.
Tandem Diabetes Care