Diabete Type 2E-cig-DMNCT07414355
Switching to E-Cigarettes After Type 2 Diabetes Diagnosis and Health Outcomes
An observational study of Diabete Type 2 and E Cigarette Use, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Diabete Type 2, E Cigarette Use, Clinical Outcomes
- What is being tested?
- Change in smoking behavior after type 2 diabetes diagnosis
- How many people
- 133,320 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2018to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- Patients diagnosed with diabetes who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- Diabete Type 2, E Cigarette Use, Clinical Outcomes
- Being tested
- Change in smoking behavior after type 2 diabetes diagnosis
- Keywords
- Diabetes mellitus, E-cigarette, Smoking
- Medical subject headings
- Diabetes Mellitus, Type 2, Vaping, Diabetes Mellitus, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in smoking behavior after type 2 diabetes diagnosisOther
Observed, self-selected change in combustible cigarette and e-cigarette use, ascertained by self-report at the first national health screening examination after diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Change in smoking behavior after type 2 diabetes diagnosis | |
| Full switching to E-cigarette | fully switching to E-cigarette users after diagnosed DM Receives: Other: Change in smoking behavior after type 2 diabetes diagnosis | |
| Smoking quitters | Adults who were smoking combustible cigarettes at the time of a new diagnosis of type 2 diabetes mellitus and who reported no combustible cigarette smoking and no e-cigarette use at the first national health screening examination after diagnosis. Smoking behavior was ascertained from the self-administered questionnaire completed at that examination. No intervention was administered; changes in smoking behavior were self-selected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infarction
The diagnosis of myocardial infarction was made if patients were hospitalized with a primary diagnostic code related to myocardial infarction (ICD-10: I21, I22) during the follow-up period.
Measured: Up to 5 years
Secondary outcomes (3)
Coronary revascularization
Coronary revascularization was defined as the presence of procedure codes for percutaneous coronary intervention or coronary artery bypass grafting after the index date.
Measured: Up to 5 years
Ischemic stroke
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.
Measured: Up to 5 years
All-cause death
All-cause death was ascertained from national death records linked to the National Health Insurance Service database.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 133,320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ki Hong Choi, Samsung Medical Center
- Investigators
- Ki Hong Choi, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414355
- Sponsor's protocol ID
- DM_E-cigarette
- Acronym
- E-cig-DM
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07414355
- Acronym / sponsor ID
- E-cig-DM / DM_E-cigarette
- Conditions
- Diabete Type 2, E Cigarette Use, Clinical Outcomes
- Keywords
- Diabetes mellitus, E-cigarette, Smoking
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 133,320 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continued combustible cigarette use | – | –Continued combustible cigarette users after diagnosed DM |
| Partial Switching to E-cigarette | – | Other: Change in smoking behavior after type 2 diabetes diagnosispartial switching to E-cigarette users after diagnosed DM |
| Full switching to E-cigarette | – | Other: Change in smoking behavior after type 2 diabetes diagnosisfully switching to E-cigarette users after diagnosed DM |
| Smoking quitters | – | –Adults who were smoking combustible cigarettes at the time of a new diagnosis of type 2 diabetes mellitus and who reported no combustible cigarette smoking and no e-cigarette use at the first national health screening examination after diagnosis. Smoking behavior was ascertained from the self-administered questionnaire completed at that examination. No intervention was administered; changes in smoking behavior were self-selected. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients diagnosed with diabetes who reported being a "current smoker" at a health examination within the 4 years prior to the diabetes diagnosis.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Change in smoking behavior after type 2 diabetes diagnosisObserved, self-selected change in combustible cigarette and e-cigarette use, ascertained by self-report at the first national health screening examination after diagnosis. | Other | Full switching to E-cigarette, Partial Switching to E-cigarette |
Primary outcome
Myocardial infarction
Time frame: Up to 5 years
The diagnosis of myocardial infarction was made if patients were hospitalized with a primary diagnostic code related to myocardial infarction (ICD-10: I21, I22) during the follow-up period.
3 secondary outcomes
Coronary revascularization
Time frame: Up to 5 years
Ischemic stroke
Time frame: Up to 5 years
All-cause death
Time frame: Up to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hong Choi, MD, PhD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 2 and E Cigarette Use, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infarction (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.