NCT07414355

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133,320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

6 years

First QC Date

January 22, 2026

Last Update Submit

February 10, 2026

Conditions

Diabete Type 2E Cigarette UseClinical Outcomes

Keywords

Diabetes mellitusE-cigaretteSmoking

Outcome Measures

Primary Outcomes (1)

  • Rates of MACE

    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.

    Up to 5 years

Secondary Outcomes (9)

  • Rates of Diabetic complications

    Up to 5 years

  • Rates of All-cause death

    Up to 5 years

  • Rates of Myocardial infarction

    Up to 5 years

  • Rates of Unplanned Revascularization

    Up to 5 years

  • Rates of Ischemic stroke

    Up to 5 years

  • +4 more secondary outcomes

Study Arms (3)

Continued combustible cigarette use

Continued combustible cigarette users after diagnosed DM

Partial Switching to E-cigarette

partial switching to E-cigarette users after diagnosed DM

Behavioral: Switching to E-cigarette

Full switching to E-cigarette

fully switching to E-cigarette users after diagnosed DM

Behavioral: Switching to E-cigarette

Interventions

Switching to E-cigaretteBEHAVIORAL

Switching to E-cigarette

Full switching to E-cigarettePartial Switching to E-cigarette

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with diabetes from 2018 onward who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis, and who could be classified after diagnosis as either continued combustible cigarette smoking ("Current") or e-cigarette use (partial or full transition).

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, Gannam-gu, 06351, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2VapingDiabetes MellitusSmoking

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesBehavior

Study Officials

  • Ki Hong Choi, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 17, 2026

Study Start

January 1, 2018

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 17, 2026

Record last verified: 2026-02

Locations

KR(1)