Evidence map›Paper›PMID 37999870›Full record

ArticleInternal and emergency medicine2024

A multicenter prospective randomized controlled trial investigating the effects of combustion-free nicotine alternatives on cardiovascular risk factors and metabolic parameters in individuals with type 2 diabetes who smoke: the DiaSmokeFree study protocol.

Arkadiusz Krysiński, Cristina Russo, Davide Campagna, Antonino Di Pino, Sarah John, Jonathan Belsey, Pasquale Caponnetto, Lorina Vudu, Chong Wei Lim, Agostino Di Ciaula and 8 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Internal and emergency medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 29% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 syntheses or guidelines pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Electronic cigarettes for smoking cessation.The Cochrane database of systematic reviews · 2025
    Pooled it
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 5 countries.

Arkadiusz KrysińskiPolish Academy of Sciences, Mossakowski Medical Research Centre Polish-Academy of Sciences, Warsaw, Poland. arkadiuszkrysinski@gmail.com.ORCID 0000-0002-4561-9574
Cristina RussoAshford and Saint Peter's Hospitals NHS Trust, Chertsey, UK.
Davide CampagnaEmergency Department, Teaching Hospital Policlinico "G. Rodolico-San Marco" of Catania, University of Catania, Catania, Italy.
Antonino Di PinoCenter of Excellence for the Acceleration of HArm Reduction (CoEHAR), University of Catania, Catania, Italy.
Sarah JohnSchool of Clinical Medicine, University of Cambridge, Cambridge, UK.
Jonathan BelseyJB Medical Ltd, Sudbury, UK.
Pasquale CaponnettoCenter of Excellence for the Acceleration of HArm Reduction (CoEHAR), University of Catania, Catania, Italy.
Lorina VuduNicolae Testemitanu State Medical and Pharmaceutical University, Chisinau, Republic of Moldova.
Chong Wei LimAshford and Saint Peter's Hospitals NHS Trust, Chertsey, UK.
Agostino Di CiaulaDivision of Internal Medicine, Department of Preventive and Regenerative Medicine and Ionian Area (DiMePrev-J), Clinica Medica "A. Murri", University of Bari Aldo Moro, Bari, Italy.
Nicola VeroneseGeriatrics Section, Department of Medicine, University of Palermo, Palermo, Italy.
Mario BarbagalloGeriatrics Section, Department of Medicine, University of Palermo, Palermo, Italy.
Farrukh IqbalThe University of Lahore University College of Medicine and Dentistry, Lahore, Pakistan.
David FluckAshford and Saint Peter's Hospitals NHS Trust, Chertsey, UK.
Edward FranekPolish Academy of Sciences, Mossakowski Medical Research Centre Polish-Academy of Sciences, Warsaw, Poland.
Riccardo PolosaCenter of Excellence for the Acceleration of HArm Reduction (CoEHAR), University of Catania, Catania, Italy.
Pankaj SharmaAshford and Saint Peter's Hospitals NHS Trust, Chertsey, UK.
DiaSmokeFree investigators
Ashford and St Peter's Hospitals NHS Foundation Trust · GBUniversity of Catania · ITCentral Clinical Hospital · PLUniversity of Palermo · ITNicolae Testemițanu State University of Medicine and Pharmacy · MDUniversity of Bari Aldo Moro · ITUniversity of Cambridge · GBUniversity of Lahore · PK

Funding

Eclat Srl Award num: ECLAT CoE1-05Università di Catania CRUI-CARE Agreement
6 · The paper itself

Abstract

Stopping 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.

Indexed as

Cardiovascular DiseasesCigarette SmokingDiabetes Mellitus, Type 2Electronic Nicotine Delivery SystemsMetabolic SyndromeSmoking CessationHeart Disease Risk FactorsHumansMulticenter Studies as TopicNicotineProspective StudiesRandomized Controlled Trials as TopicRisk FactorsNicotineCardiovascular risk factorsDiabetese-CigarettesGlycemic controlHeated tobacco productsMetabolic syndromeSmoking cessationTobacco harm reduction

Identifiers

PMID37999870
PMCPMC10954907
OpenAlexW4388975683

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.