The study was designed to determine the effect of TPT vs. standard care (SC) on change in A1C and T2DM remission at 90 day intervals, in addition to multiple secondary endpoints. The TPT intervention uses the Whole-Body Digital Twin Platform, with AI and Internet of Things, to integrate multi-dimensional data to give precision nutrition and health recommendations via the TPT app and by coaches. Baseline mean age, diabetes duration and A1C obtained in 319 pts were 45y (±9.7y) , 3.9y (±2.9y) and 9.0% (±1.9%) , respectively. Interim analysis of 262 pts (TPT n=199; SC n=63) who reached 180d showed 94.9% (189/199) of TPT pts had A1C < 6.5%, on no medications or metformin only; 83.9% (167/199) achieved diabetes remission based on ADA criteria. All 9 insulin-using pts stopped insulin before 90d. The Table shows significant improvement in secondary endpoints in TPT pts at baseline and 180d, including A1C (9.0% to 5.7%, P<0.001) . TPT pts had -3.3% change in A1C (95% CI -3.6 to -3%, P=<0.001) compared to SC with -0.39% (95% CI -0.73 to -0.043%, P=0.028) , with a significant between-group difference (P=<0.0001) . The TPT intervention in pts with T2DM allowed for significant reduction in A1C, diabetes remission (∼84%) and improvement in multiple metabolic parameters at 6 months. Future long-term studies are needed to support these initial findings.
P. Shamanna: None. M. Thajudeen: None. A. Keshavamurthy: None. F. R. Kaufman: Consultant; Twin Health, Employee; Senseonics. S. R. Joshi: Advisory Panel; AstraZeneca, Consultant; Biocon, Franco India, Glenmark Pharmaceuticals, Marico, Sanofi, Twinhealth, Zydus Cadila, Speaker’s Bureau; Abbott, Serdia Pharmaceuticals (India) Pvt. Ltd. L. Shah: None. J. Mohammed: None. M. Mohamed: None. T. Poon: None. M. Dharmalingam: None. B. Saboo: None. S. Damodharan: None. A. Vadavi: None.