A Multi-center 13-week Evaluation of the twiist Automated Insulin Delivery in Insulin-Treated Type 2 Diabetes: the twiist-T2D Pivotal Trial

Authors:
  • CLCarol J. Levy
    Carol J. Levy
  • LKLauren Kanapka
    Lauren Kanapka
  • TGTimothy E. Graham
    Timothy E. Graham
  • DKDavida F. Kruger
    Davida F. Kruger
  • YKYogish C. Kudva
    Yogish C. Kudva
  • TBThomas Blevins
    Thomas Blevins
  • VSViral N. Shah
    Viral N. Shah
  • ACAnders L. Carlson
    Anders L. Carlson
  • DLDavid R. Liljenquist
    David R. Liljenquist
  • KDKathleen Dungan
    Kathleen Dungan
  • DHDavid Huffman
    David Huffman
  • KCKristin Castorino
    Kristin Castorino
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Abstract
Objective: To evaluate the efficacy, safety, and user satisfaction of the twiist automated insulin delivery (AID) system in adults with type 2 diabetes. Research Design and Methods: In a single-arm, multi-center trial, 307 adults with insulin-treated type 2 diabetes, 19 to 85 years old, initiated use of the twiist AID system for 13 weeks after collection of baseline CGM data. The primary outcome was change in HbA1c from baseline to 13 weeks. Results: Mean HbA1c decreased by 0.7% (95% CI -0.9 to -0.6) from 8.1±1.5% at baseline to 7.4±0.9% after using twiist for 13 weeks (P<0.001 for non-inferiority and P<0.001 for superiority). The treatment effect was greatest in participants with baseline HbA1c ≥9.0%. A substantial HbA1c reduction was observed when AID was added to pre-study use of a GLP-1RA or SGLT2i drug which was continued during the trial. Mean CGM-measured time-in-range 70-180 mg/dL increased from 57±26% to 73±17% (mean change = 16%, 95% CI 14% to 18%, P<0.001). All other multiplicity-controlled CGM outcomes reflective of hyperglycemia showed significant improvement from baseline. The frequency of CGM-measured hypoglycemia was low at baseline and remained low during follow up. Diabetic ketoacidosis occurred in one participant; no severe hypoglycemia events occurred. Using twiist, participant satisfaction was higher than with their prestudy insulin delivery method (P<0.001) and sleep quality improved (P<0.001). Conclusions: In this single-arm 13-week trial in adults with insulin-treated type 2 diabetes, AID with the twiist system was safe and associated with substantially improved glycemia. Clinicaltrials.gov: NCT06853990
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