1067-OR: A Multicenter Trial Assessing the Efficacy and Safety of the Novel Twiist Automated Insulin Delivery (AID) System in Adults with Insulin-Treated Type 2 Diabetes (T2D)

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Introduction and Objective: Despite GLP1ra or SGLT2i therapy, many adults with insulin treated type 2 diabetes (T2D) remain above HbA1c targets. AID may provide benefit for T2D. The study objective was to evaluate efficacy and safety of the twiist AID system, which uses the novel twiist pump and Tidepool Loop algorithm, in adults with insulin-treated T2D.Methods: At 30 U.S. sites, 307 adults ≥18yo with T2D using insulin (MDI, pump, or basal insulin only) initiated twiist (Apr-Nov 2025) for 13wks. An interim analysis was conducted after first 32 participants had initiated twiist, prior to enrolling the rest of the cohort.Results: Mean age of the 307 participants was 58 ± 13 yrs; 44% were of a minority race or ethnicity. Mean baseline A1c was 8.2 ± 1.5%; 55% were using a GLP-1ra and 37% an SGLT2i drug. Among the initial 25 participants (mean age 53 ± 13yrs, A1c 8.0 ± 1.2%; median twiist use 28.4 days), TIR 70-180 mg/dL improved from 60% at baseline to 77%. Benefit was evident across a wide range of characteristics, including A1c, BMI, GLP-1ra use, and duration of diabetes (Figure). Time <70 mg/dL decreased from 0.86 ± 1.44% to 0.25 ± 0.49%.Conclusion: In a diverse population with insulin-treated T2D, twiist improved TIR without safety concerns. Rapid, substantial improvement was observed broadly across a wide range of participant characteristics. The 307 participants will complete 13wk follow up in February 2026.

Disclosure

C. Levy: Research Support; Current; Tandem Diabetes Care, Inc., Novo Nordisk, Abbott Diabetes, MannKind Corporation. Consultant; Current; MannKind Corporation, Tandem Diabetes Care, Inc. Research Support; Current; Deka/Sequel, Dexcom, Inc., Genti Bio. Consultant; Current; Deka/Sequel. J. Mitri: Employee; Current; Sequel. K. Snow: Employee; Current; Sequel Medtech. R.W. Beck: Research Support; Current; MannKind Corporation, Abbott Diabetes, Dexcom, Inc., Tandem Diabetes Care, Inc., Sequel Med Tech, DreaMed Diabetes, Ltd. Consultant; Ended; Novo Nordisk, Eli Lilly and Company. Consultant; Current; Zucara Therapeutics.

Funding

DEKA Research & Development Corp



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