SAT-845 - Real-World Glycemic Gains with the Beta Bionics Ilet Insulin Pump

Background: Automated insulin delivery systems reduce user burden and improve glycemic outcomes. The Beta Bionics iLet is a fully automated insulin pump designed to simplify dosing and optimize glucose control. While clinical trials show efficacy, real-world outcomes, particularly paired pre- and post-initiation data, are limited.

Objective: To assess real-world changes in glycemic metrics before and after iLet initiation using paired outpatient data.

Methods: We performed a retrospective paired analysis of adults who initiated the iLet and had complete pre- and post-initiation data, including glucose management indicator (GMI), continuous glucose monitoring metrics, and hemoglobin A1c. Patients with incomplete data were excluded. Outcomes included GMI, time in clinically significant hypoglycemia ( < 54 mg/dL), hyperglycemia measures, and A1c. Pre- and post-values were compared within individuals using paired statistical tests (p < 0.05).

Results: Forty-five patients met the inclusion criteria. iLet initiation was associated with improvements across multiple glycemic metrics. GMI and A1c decreased post-initiation, while time in hypoglycemia ( < 54 mg/dL) and measures of hyperglycemia were reduced. Improvements in glycemic control occurred without increased hypoglycemia, supporting safety in routine outpatient use.

Discussion: In this real-world paired analysis, iLet use led to meaningful improvements in glycemic outcomes, including reduced hypoglycemia, hyperglycemia, and A1c. These findings extend clinical trial results, showing effectiveness in routine practice. The automated design may lower glycemic variability and hypoglycemia risk across patients with diverse baseline control and prior diabetes therapies. The paired design strengthens causal inference by minimizing inter-individual variability. Limitations include the retrospective design, modest sample size, variable follow-up, and reliance on available clinical data. Despite these, consistent benefits across metrics support real-world effectiveness.

Conclusion: Among adults with paired data, Beta Bionics iLet initiation improved glycemic control and reduced hypoglycemia in outpatient practice. These results support the iLet system as an effective automated insulin delivery option with the potential to enhance diabetes outcomes.

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