Samsung Medical Center
Seoul, Gannam-gu, 06351, South Korea
NCT Number: NCT07414355
Individuals with T2DM who smoke have higher risks of cardiovascular disease and other complications. Many people consider e-cigarette as a "harm-reduction" alternatives to combustible cigarettes, but it is not clear whether switching to e-cigarettes improves health outcomes in patients with diabetes.
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Notify Me40 year–75 year
All sexes
Observational
Seoul, Gannam-gu, 06351, South Korea
Use of electronic cigarettes has increased, partly driven by the perception that they may serve as a "harm-reduction" alternative to combustible cigarettes. Evidence cited in prior work includes higher cessation rates versus nicotine replacement therapy in a randomized trial and reductions in biomarkers of potential harm after switching from combustible cigarettes to e-cigarettes; observational data in high-risk PCI populations have also suggested lower MACCE risk after switching. However, constituents such as nicotine and heavy metals may adversely affect diabetes management, and most prior studies have emphasized potential harms of e-cigarette use itself. As a result, whether switching from combustible cigarettes to e-cigarettes confers a harm-reduction benefit in patients with diabetes remains uncertain. In this regards, the current study evaluated clinical outcomes associated with switching from combustible cigarettes to e-cigarettes in patients with diabetes and to assess whether the degree of switching (partial vs full transition) modifies the risk of adverse clinical events.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Switching to E-cigarette
Time frame: Up to 5 years
MACE was defined as the composite of all-cause death, MI, and repeat revascularization. The diagnosis of MI was made if patients were hospitalized with primary diagnostic codes related to MI (ICD-10 I21, I22) during follow-up period. In a previous validation study, the accuracy of diagnosis of MI in NHIS data was 93%.16 Unplanned revascularization was defined as presence of procedure codes for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index date.
Time frame: Up to 5 years
Diabetic complications were defined as presence of diabetic neuropathy (ICD-10: E10.4, E11.4, E12.4, E13.4, E14.4, G59.0, G63.2, and G99.0), diabetic foot without amputation (ICD-10: E10.5, E10.7, E11.5, E11.7, E12.5, E12.7, E13.5, E13.7, E14.5, and E14.7), diabetic foot with amputation (ICD-10: E10.5, E10.7, E11.5, E11.7, E12.5, E12.7, E13.5, E13.7, E14.5, and E14.7; procedure codes: N0572-0575), and diabetic retinopathy, including non-proliferative (ICD-10: H360) and proliferative (ICD-10: H360; procedure codes: S5160 and S516) forms.
Time frame: Up to 5 years
the individual components of MACE
Time frame: Up to 5 years
the individual components of MACE. The diagnosis of MI was made if patients were hospitalized with primary diagnostic codes related to MI (ICD-10 I21, I22) during follow-up period.
Time frame: Up to 5 years
Unplanned revascularization was defined as presence of procedure codes for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) after index date.
Time frame: Up to 5 years
Stroke was defined based on ICD codes for ischemic stroke (ICD-10 I63, I64) or intracranial hemorrhage (ICD-10 I60-62), combined with the codes for hospitalization.
Time frame: Up to 5 years
Hemorrhage stroke was defined based on ICD codes for intracranial hemorrhage (ICD-10 I60-62), combined with the codes for hospitalization.
Time frame: Up to 5 years
Mild pulmonary disease were identified using validated ICD-10 codes.
Time frame: Up to 5 years
Hospitalization for exacerbation in patients with a documented pulmonary disease code.
Time frame: Up to 5 years
Cancer was defined as the presence of cancer-specific insurance claim code (V193 code) with a C code which was an ICD-10 code for cancer.
Samsung Medical Center
Other
Clinical Outcomes Associated With Switching From Combustible Cigarettes to Electronic Cigarettes Among Adults With Newly Diagnosed Type 2 Diabetes: A Nationwide Retrospective Cohort Study
Acronym: E-cig-DM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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