Whole Body Digital Twin Technology for Remission of T2DM and Improvement In Fatty Liver: 1 Year Results of the Prospective Randomized Controlled Clinical Trial
Director Bangalore Diabetes Centre Bangalore, Karnataka, India
Objective: Twin Precision Treatment (TPT) is a novel Whole-Body Digital Twin (WBDT) enabled precision nutrition for reversing diabetes, that uses AI and the Internet of Things, to integrate multidimensional data, from non-invasive sensors, to give precision nutrition and health recommendations via the TPT app and by coaches.
Methods: We conducted a prospective randomized trial to compare the changes in the glycemic metrics and the fatty liver parameters. The Intent to Treat (ITT) analysis among 233 people with T2DM who underwent WBDT was done at one year. This was compared to 84 T2DM subjects in standard of care (SC) arm. Remission was defined as an A1C level <6.5% for ≥ six months without diabetes medication use for at least 90 days.
Results: Of the 233 people with T2DM, completed more than six months of WBDT. 72.7% (152/209) sustained remission at one year. The mean age, duration of diabetes, were 43 years (±9.5, range 17 to 69) and 3.4 years (±2.7, range 0.1 to 8), respectively. In WBDT group there was a significant change (p < 0.0001) (mean±SD) from the baseline to 1 year, for HbA1c (%) 9 (±1.9) to 6.1 (±2.9), body weight (kg) 78.3 (±14.5) to 71 (±13.5), HOMA2-IR 1.9 (±0.9) to 1.2 (±0.6). In WBDT as compared to SC, there were significant improvements (p < 0.0001) observed in NAFLD liver fat score -2.1 (±14.5) vs 0.2 (±1.8), NAFLD liver fibrosis score -0.7 (±0.8) vs -0.2 (±0.9), Fatty Liver Index -27.7 (±20.2) vs 1.6 (±15.5) and Framingham Steatosis Index 31.9 (±24.3) vs -1.9 (±24.8); Liver enzymes - ALT (U/L) -14.3 (±32.7) vs -3.5 (±26.7), AST (U/L) -4.5 (±16.8) vs -0.1 (±23.1), GGT (U/L) -12.5 (±24) vs -4.6 (±52). One-year improvement in HbA1C was significantly better for WBDT than SC -3.0 (±1.8) vs. -0.2 (±1.2); p < 0.001.
Discussion/Conclusion: Our ITT analysis shows that WBDT enables a high rate of remission of T2DM with a durable benefit, beyond six months for the glycemic control and consistent improvement in the parameters of fatty liver, at one year.