Remission of T2DM by digital twin technology with reduction of cardiovascular risk: interim results of randomised controlled clinical trial
Authors: Shamanna P , Joshi S , Shah L , Dharmalingam M , Vadavi A , Damodaran S , Mohammed J , Mohamed M , Poon T , Keshavamurthy A , Mohamed T , Bhonsley S 
Published: February 2022

Abstract

Funding Acknowledgements
Type of funding sources: Private company. Main funding source(s): TWIN HEALTH INC

Background
Twin Precision Treatment (TPT) is a novel intervention designed to improve glycemia and reverse T2D using a Whole-Body Digital Twin (WBDT) platform powered by Artificial Intelligence and the Internet of Things. 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. WBDT platform captures 174 health markers and 3000 daily data points through a panel of blood tests and connected devices that measure weight, physical activity, sleep and BP. CGM is used initially and then the algorithm predicts personalized glucose responses from multiple inputs. Nutritional, physical activity and sleep counseling is through an app or phone to provide individualized meal plans that balance 87 macro, micro and probiotic nutrients to reduce glucotoxicity and lipotoxicity. Program physicians titrate medications and monitor metabolic outcomes.

Purpose
To assess the initial change, in glycemic, extra glycemic, cardiovascular parameters for patients who completed 3 months longitudinal follow up.

Methods
We performed an interim analysis [n = 173, 139 TWIN Intervention arm (T), 34 Control group (C)] of ongoing randomized controlled trial of TPT across India

Results
The mean age (years) in the T was 43.04 (±8.6, 95% CI 41.57 to 44.52) which was significantly less as compared to the C 51.4 (±9.6, 95% CI 48.3 to 54.5); p &lt; 0.0001. The mean duration of diabetes (years) in the T was 3.5 (±2.6) which was comparable to the C 4.3 (±2.6); p = 0.12 ns. In the T there were 113 male (84.3%) and 21 female (15.6%) as compared to C, 15 male (38.4%) and 24 female (61.5%); p &lt; 0.0001. The difference of change for HbA1c (%), small dense LDL-C sdLDL (mg/dL), TG/HDL Ratio, HOMA 2IR (%), Visceral Adiposity Index (VAI), Systolic BP (mmHg), BMI (kg/m2), Framingham Risk Score (%), in T when compared to C, were significant. The mean reduction HbA1c, sdLDL, HOMA 2IR, VAI, SBP, BMI, FRS in T was -3.2 % (8.8 to 5.6), -14.1 mg/dL, (52.6 to 38.5), -0.9 % (1.9 to 1), -2.3 (4.6 to 2.3), -10.3mmHg (128.4 to 118.1), -2.9 kg/m2 (27.1 to 24.2), -7.9% (16 to 8.1), respectively. (figure) At baseline in T, mean daily intake of medication was 1.7 which reduced significantly (p &lt; 0.0001) to 0.05. 96 patients in T were able to stop anti-diabetic medications

Discussion
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 and Artificial Intelligence, as a modality to enable reversal of diabetes. TPT appears to have potential to mitigate the cardiovascular risk as assessed by Framingham Risk Score and modulate the non glycemic parameters, including BMI and SBP. However, larger, long-term studies would yield precise insights for the durability of the significant change that has been observed in this study Abstract Figure. Comparison for the Change in the Glycemi