Currently submitted to: JMIR Research Protocols
Date Submitted: Mar 20, 2026
Open Peer Review Period: Mar 23, 2026 - May 18, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Expert Consensus on Smoking Cessation and Harm Reduction in Type 2 Diabetes Mellitus: An International Modified Delphi Study Protocol
ABSTRACT
Background:
Cigarette smoking remains highly prevalent among people living with type 2 diabetes mellitus (T2DM) and is independently associated with accelerated cardiovascular disease, worsened microvascular complications, and premature mortality. Despite strong evidence supporting pharmacological and behavioural cessation interventions, the integration of structured tobacco treatment into routine diabetes care remains inconsistent across healthcare systems. Furthermore, ongoing controversies surround the potential role of tobacco harm reduction (THR) strategies—including electronic nicotine delivery systems (ENDS)—for individuals who are unable or unwilling to achieve complete abstinence from tobacco.
Objective:
This protocol describes an international, modified Delphi study designed to generate expert consensus on optimising smoking cessation care and on the place of THR approaches in the management of T2DM, and to prioritise pragmatic, evidence-informed recommendations for clinical practice and future research.
Methods:
A multidisciplinary Steering Committee will develop a structured set of consensus statements informed by the DiaSmokeFree evidence base and framed using PICO-oriented questions across eight clinical domains. We will recruit 30–50 international experts from relevant scientific societies and clinical disciplines. Participants will complete two to three anonymous online rating rounds over approximately two to three months. Each statement will be rated on a 6-point Likert scale (1 = strongly disagree to 6 = strongly agree). Consensus will be defined a priori as ≥85% of respondents rating within a single agreement category (1–2, 3–4, or 5–6). Statements not reaching consensus will be revised on the basis of quantitative feedback and free-text comments and re-rated in subsequent rounds. Ethics and dissemination: Ethical approval will be sought where required by local regulations. Participation is voluntary with informed consent. Results will be reported in accordance with the Conducting and REporting DElphi Studies (CREDES) guidance and disseminated as an open-access consensus statement, a suite of practical clinical tools, and a prioritised research agenda to support the integration of evidence-based tobacco treatment and harm reduction into T2DM care.
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