The Omnipod 5 AID System was associated with improvement in glycemic outcomes for people with T1D regardless of baseline glycemic management in two single-arm pivotal clinical trials. Baseline HbA1c is an important factor to consider when optimizing outcomes with AID, as new user needs and expectations vary. This study evaluated real-world outcomes with the Omnipod 5 System for users with sub-optimal HbA1c >9% prior to starting on the system. CGM and insulin data from Omnipod 5 users with T1D aged ≥2y and using ≥5 units of insulin per day in the US with ≥90 days of data available in the cloud-based data management system were included. Data from 7,876 users with sufficient CGM data (≥75% of days with ≥220 readings) with self-reported baseline HbA1c >9% were available at the time of analysis. Outcomes are shown in the Table, with results reported as median [IQR]. Users achieved a GMI of 7.99%, TIR of 48.7%, and a TBR of 0.60%, while bolusing 3.4 x/d, corresponding to an estimated HbA1c decrease of >1%. Of this group, those using an average glucose target of 110mg/dL, bolusing ≥3 x/d, and with ≥85% time in Automated Mode achieved a TIR of 60.7% and >1.5% estimated decrease in HbA1c, with 52.5% of users achieving a GMI <7.5%. These results in >7,500 users with high baseline HbA1c indicate clinically meaningful improvements in glycemic outcomes with real-world use of the Omnipod 5 System.

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Disclosure

G.P. Forlenza: Research Support; Abbott, Dexcom, Inc. Consultant; Dexcom, Inc. Research Support; Insulet Corporation. Consultant; Insulet Corporation. Research Support; Medtronic. Advisory Panel; Medtronic. Research Support; Tandem Diabetes Care, Inc. Consultant; Tandem Diabetes Care, Inc. J.L. Sherr: Consultant; Medtronic. Advisory Panel; Medtronic, Insulet Corporation. Speaker's Bureau; Insulet Corporation. Advisory Panel; Vertex Pharmaceuticals Incorporated, MannKind Corporation, StartUp Health T1D Moonshot, Bigfoot Biomedical, Inc., Cecelia Health. Speaker's Bureau; Zealand Pharma A/S. D. DeSalvo: Advisory Panel; Insulet Corporation. Consultant; Dexcom, Inc. G. Aleppo: Consultant; Dexcom, Inc., Insulet Corporation. Research Support; Insulet Corporation. Consultant; Medscape. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc., WellDoc, Fractyl Health, Inc. Consultant; Eli Lilly and Company, Bayer Inc. Research Support; Emmes. E.G. Wilmot: Other Relationship; Abbott. Speaker's Bureau; AstraZeneca. Other Relationship; Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, embecta, Medtronic, Novo Nordisk. Advisory Panel; Roche Diabetes Care. Other Relationship; Sanofi. Speaker's Bureau; Ypsomed AG. C. Berget: Speaker's Bureau; Dexcom, Inc., Insulet Corporation, embecta. L.M. Huyett: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. I. Hadjiyianni: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. J.J. Mendez: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. L. Conroy: Employee; Insulet Corporation. Stock/Shareholder; Insulet Corporation. T.T. Ly: Employee; Insulet Corporation.

Funding

Insulet Corporation

© 2024 by the American Diabetes Association
2024
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