• Arkadiusz Krysiński, Cristina Russo, Davide Campagna, Antonino Di Pino, Sarah John, Jonathan Belsey, Pasquale Caponnetto, Lorina Vudu, Chong Wei Lim, Agostino Di Ciaula, Nicola Veronese, Mario Barbagallo, Farrukh Iqbal, David Fluck, Edward Franek, Riccardo Polosa, Pankaj Sharma, and DiaSmokeFree investigators.
• Polish Academy of Sciences, Mossakowski Medical Research Centre Polish-Academy of Sciences, Warsaw, Poland. arkadiuszkrysinski@gmail.com.
• Intern Emerg Med. 2024 Mar 1; 19 (2): 321332321-332.

AbstractStopping smoking is crucial for public health and especially for individuals with diabetes. Combustion-free nicotine alternatives like e-cigarettes and heated tobacco products are increasingly being used as substitutes for conventional cigarettes, contributing to the decline in smoking prevalence. However, there is limited information about the long-term health impact of those products in patients with diabetes. This randomized controlled trial aims to investigate whether switching from conventional cigarettes to combustion-free nicotine alternatives will lead to a measurable improvement in cardiovascular risk factors and metabolic parameters over a period of 2 years in smokers with type 2 diabetes. The multicenter study will be conducted in seven sites across four countries. A total of 576 smokers with type 2 diabetes will be randomly assigned (1:2 ratio) to either standard of care with brief cessation advice (Control Arm) or combustion-free nicotine alternatives use (Intervention Arm). The primary end point is the change in the proportion of patients with metabolic syndrome between baseline and the 2-year follow-up. Additionally, the study will analyze the absolute change in the sum of the individual factors of metabolic syndrome at each study time point. Patient recruitment has started in September 2021 and enrollment is expected to be completed by December 2023. Results will be reported in 2026. This study may provide valuable insights into cardiovascular and metabolic health benefits or risks associated with using combustion-free nicotine alternatives for individuals with type 2 diabetes who are seeking alternatives to tobacco cigarette smoking. The study protocol, informed consent forms, and relevant documents were approved by seven ethical review boards. Study results will be disseminated through articles published in high-quality, peer-reviewed journals and presentations at conferences.© 2023. The Author(s).

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