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Article History

Received: 30 December 2024

Accepted: 23 April 2025

First Online: 12 May 2025

Declarations

:

: Shitole V. and Kumar P. are the co-founders of Iota Diagnostic Private Limited, a company that develops medical and diagnostic technology and other healthcare activities and sponsored this investigation. Shitole V. and Kumar P. are listed as an inventors of patents affiliated with Iota Diagnostic Private Limited. Septa V. is a paid employee of Iota Diagnostic Private Limited and was sponsored through this project. Mondol B. has no financial involvement or conflict with the subject matter of the material discussed in the manuscript.

: The authors state that they have obtained appropriate Institutional Ethics Committee approval and have followed the principles outlined in the Declaration of Helsinki for all human experimental investigations. Study approval was granted by the Institutional Ethics Committee at Pranav Diabetes Center, Bengaluru,Karnataka, INDIA (ECR/1217/Inst/KA/2019). The Authors also state that they have obtained regional regulatory approval from CDSCO, India (MFG/TL/IVD/2022/000726) and the Clinical Trial Registry of India (CTRI/2022/12/048267) and have followed the ICH GCP guidelines, and Ethical guidance for all the human investigations.

: On behalf of all the authors, the corresponding author affirms that human and animal rights were upheld in the study.

: On behalf of all authors, the corresponding author states that informed consent was obtained from all the participants involved in the study.