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A Multicentric Case–Control Study for Diagnostic Utility of Non-contact Infrared Thermography (IRT) in Type 2 Diabetes

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Abstract

While there is a renewed interest in the use of infrared imaging in the medical field owing to improvements in image acquisition and processing technologies, its utility in the diagnosis of diabetes mellitus on a large scale has not been adequately evaluated in previous studies. This was a multicenter, double-blind case–control trial across three centers in India which enrolled a total of 1095 adults in two groups—590 participants with diabetes and 505 healthy controls. The primary outcome was the difference in thermography readings between the two groups. The secondary outcomes included the correlation of thermography readings with HbA1C, considered the gold standard. The thermography readings at all seven sites were lower in people with diabetes as compared to the control group. However, this attained statistical significance across four sites—forehead (Δmean difference = 0·34, 95% CI [0·14–0·53], medial canthus of both eyes (Δmean difference = 0·48, 95% CI [0·31–0·66], pinna of both ears (Δmean difference = 0·53, 95% CI [0·28–0·73]) and palmar surface of both hands (Δmean difference = 0·28, 95% CI [0·02–0·53]). In addition, thermography readings showed a significant negative correlation with HbA1C values across these four sites, although the strength of the correlation was weak. This study sheds light on the utility of thermography for large-scale noninvasive diagnosis of diabetes mellitus. Future research should focus on large-scale community screening of early asymptomatic disease as well as micro- and macrovascular complications to define its exact role in the overall disease management pathway.

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Data Availability

Deidentified participant data including statistical analysis plan and code will be made available after publication upon request to the corresponding author (drsanjeevsinha@gmail.com).

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Acknowledgements

We would like to thank Science and Engineering Research Board, Department of Science and Technology, for funding this project. We would also like to thank all the staff who were part of the project at the three centers for their contribution in this project.

Funding

This study was funded by Science and Engineering Research Board, Department of Science and Technology, Government of India.

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Authors and Affiliations

Authors

Contributions

SS and SG conceptualized the study and determined the methodology. SS and SK recruited participants at AIIMS, New Delhi. SS, AA, RT and KS collected and analyzed data, reviewed the literature and wrote the manuscript. SG contributed to patient recruitment at SGPGI Lucknow as well as analysis of data and editing of the manuscript. SS, SG and HB performed project management roles as team leaders. SP did the final statistical analysis. SS, AA, RT, SG, HB, KS and SP accessed and verified the data. All authors reviewed and edited the manuscript and approve the final version. All authors had full access to all the data in the study and had final responsibility for the decision to submit for publication.

Corresponding author

Correspondence to Sanjeev Sinha.

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Conflict of interest

All the authors declare no competing interests with respect to this study.

Ethical Approval

This study was done in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonization–Good Clinical Practice guidelines. Ethics approval for the study was obtained from the ethics committee of All India Institute of Medical Sciences, New Delhi (IEC-44/09.2.2017), prior to study initiation.

Informed Consent

All study participants gave written informed consent for inclusion in this study.

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Sinha, S., Ajayababu, A., Titiyal, R. et al. A Multicentric Case–Control Study for Diagnostic Utility of Non-contact Infrared Thermography (IRT) in Type 2 Diabetes. Natl. Acad. Sci. Lett. (2024). https://doi.org/10.1007/s40009-023-01381-1

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