Krysinski 2021.

Study name	International randomized controlled trial evaluating metabolic syndrome in type 2 diabetic cigarette smokers following switching to combustion‐free nicotine delivery systems: the DIASMOKE protocol
Methods	Design: RCT, multicentre
Participants	576 People with type 2 diabetes who smoke cigarettes Participants will be at least 23 years old and of any gender
Interventions	Control arm (Study Arm A), in which they will be offered referral to smoking cessation programmes, or to an intervention arm (Study Arm B) assigned to combustion‐free nicotine delivery systems (C‐F NDS) use
Outcomes	Primary outcome measures include fasting plasma glucose, blood pressure, triglycerides, high‐density lipoprotein and waist circumference, while secondary feature absolute change in the sum of the individual factors of MetS and change in each individual factor of MetS measured at each study time point
Starting date	Participant recruitment will start in February 2021 and is expected to be completed by December 2021
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