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Completed

NCT Number: NCT07414355

Switching to E-Cigarettes After Type 2 Diabetes Diagnosis and Health Outcomes

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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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, Gannam-gu, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with diabetes who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis.

Exclusion criteria

  • age <40 years or ≥75 years
  • Pre-existing AMI before diabetes diagnosis
  • Pre-existing Revascularization before diabetes diagnosis
  • Pre-existing diabetes complications before diabetes diagnosis
  • Pre-existing cancer before diabetes diagnosis
  • Death within 6 months of the first health examination after diabetes diagnosis
  • Cancer within 6 months of the first health examination after diabetes diagnosis

Treatment and study plan

Switching to E-cigarette

Behavioral

Switching to E-cigarette

Primary outcomes

  1. Rates of MACE

    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.

Secondary outcomes

  1. Rates of Diabetic complications

    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.

  2. Rates of All-cause death

    Time frame: Up to 5 years

    the individual components of MACE

  3. Rates of Myocardial infarction

    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.

  4. Rates of Unplanned Revascularization

    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.

  5. Rates of Ischemic stroke

    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.

  6. Rates of Hemorrhage stroke

    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.

  7. Rates of Mild pulmonary disease

    Time frame: Up to 5 years

    Mild pulmonary disease were identified using validated ICD-10 codes.

  8. Rates of Severe exacerbation of Pulmonary disease

    Time frame: Up to 5 years

    Hospitalization for exacerbation in patients with a documented pulmonary disease code.

  9. Rates of Cancer

    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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

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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