Response to Twin Enabled Precision Treatment for Reversing Diabetes: An Initial Analysis at 4 Weeks of the Ongoing Randomised Controlled Trial

Introduction: Technology enabled precision nutrition, a combination of macro, micro and biota nutrients, along with Continuous Glucose Monitoring (CGM) have been demonstrated to be a key for reversal of diabetes. Methods: We conducted an initial analysis (n=23) of the ongoing randomized controlled trial of Twin Precision Treatment (TPT): a novel whole-body digital twin enabled precision treatment for reversing diabetes. The clinical and the biochemical parameters were evaluated as the longitudinal follow up at the first follow up visit at 4 weeks. The target sample size is 300 with an estimated duration of 5 years. Descriptive statistics were used Results: 8/23 (35%) patients achieved the intended outcome of reversal of HbA1c and off any anti-diabetic medications. There was a statistically significant improvement in HbA1c % (8.5 ± 1.6 to 6.8 ± 0.66; p<0.0001), Fasting Blood Glucose mg/dL (FBS) (151 ± 44 to 98 ± 18; p<0.0001), HOMA2-IR (1.7 ± 0.64 to 1 ± 0.45; p=0.0001), HOMA2-Beta (53 ± 28 to 86 ± 38; p=0.0013), Systolic BP (129 ± 11 to 120 ± 11; p=0.008) and serum albumin g/dL (4.5 ± 0.21 to 4.2 ± 0.31; p=0.0042). The baseline values for the other parameters including body weight, waist circumference, Diastolic BP, Alanine transaminase (ALT), Gamma-glutamyl transferase (GGT), eGFR, WBC, Platelet, Globulin, ESR, demonstrated a clinically relevant, superior change Discussion: The initial analysis for the prospectively designed trial reveals a remarkable improvement in the clinical and the biochemical parameters that would determine the complete and the prolonged remission of diabetes. The initial results are an early indicator for the translation of the scientific rationale for the technological intervention, through digital twin technology, powered by Internet of Things (IoT) and Artificial Intelligence (AI), as a modality to enable reversal of diabetes into an achievable outcome that would be durable. The impactful glycemic control appears to have positive meaningful metabolic health consequences Trial Registration: The trial has been prospectively registered in Clinical Trial Registry – India: Reference no. CTRI/2020/08/027072 on August 10, 2020