DisabilitiesNCT07052708
The Impact of Medication Adherence in Patients With Type 2 Diabetes and Disabilities
An observational study of Disabilities and Type 2 Diabetes, run by Samsung Medical Center.
Trial summary
Individuals with disabilities and type 2 diabetes tend to have worse clinical outcomes. To identify modifiable factors that may improve these outcomes, the investigators evaluated the role of medication adherence. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Disabilities, Type 2 Diabetes
- What is being tested?
- No adherence group and Adherence group
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 365,295 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2010to 30 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients newly diagnosed with T2DM and without prior major cardiovascular or malignant conditions.
Who may be able to join
- Patients who newly diagnosed T2DM between between January 1, 2010, and December 31, 2023
Who cannot join
- individuals with a history of MI, stroke, percutaneous coronary intervention, peripheral arterial disease, chronic kidney disease, or cancer before the diagnosis of diabetes were excluded.
- individuals with who already had diabetics related complication
About this study
Official title: Impact of Medication Adherence on Cardiovascular Outcomes in Individuals With Type 2 Diabetes and Disabilities: Nationwide Cohort Study
Individuals with disabilities and type 2 diabetes tend to have worse clinical outcomes. To identify modifiable factors that may improve these outcomes, the investigators evaluated the role of medication adherence. A retrospective, cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is a well-established risk factor for cardiovascular disease (CVD). In recent years, self-care has become a central component of diabetes management, with growing emphasis on medication adherence, physical activity, and lifestyle modifications to reduce CVD risk and improve long-term outcomes. As a result, limited capacity for self-care has been increasingly recognized as a major contributor to health disparities.
Approximately 25% of individuals with disabilities have T2DM, and those with physical or mental impairments often face substantial barriers to effective self-management. These challenges-including limited mobility and reduced access to health information-can lead to poor glycemic control and heightened cardiovascular risk.
However, most prior studies have primarily focused on describing the elevated risk of CVD in individuals with disabilities. Whether suboptimal medication adherence mediates the association between disability and cardiovascular outcomes remains unclear.
Therefore, this study aims to compare medication adherence between patients with and without disabilities and to assess whether differences in adherence contribute to disparities in the incidence of CVD.
- Conditions
- Disabilities, Type 2 Diabetes
- Being tested
- No adherence group, Adherence group
- Keywords
- medication adherence
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No adherence groupBehavioural
Patients with poor adherence was defined as medication possession ratio(MPR) <50%.
Adherence groupBehavioural
Patients with good adherence was defined as medication possession ratio(MPR) ≥50%.
| Study group | Role | What they receive |
|---|---|---|
| Disability | Individuals were classified as having a disability if they were officially registered as of the index date. Physical disability included conditions such as limb impairment, brain lesion, visual or auditory impairment, speech impairment, facial disfigurement, and epilepsy. Mental disability included intellectual disability, autism spectrum disorder, and psychiatric disorders. Receives: Behavioral: No adherence group; Behavioral: Adherence group | |
| No disability | Individuals who were not officially registered with any physical or mental disability as of the index date. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events (MACCE)
Composite of MI, ischemic stroke, hemorrhagic stroke, and all-cause mortality
Measured: 10 years after diagnosed T2DM
Secondary outcomes (5)
Diabetic neuropathy
Nerve damage resulting from DM
Measured: 10 years after diagnosed T2DM
Diabetic foot without amputation
Diabetic foot complications, such as ulcers, infections, or gangrene, without any lower-extremity amputation
Measured: 10 years after diagnosed T2DM
Diabetic foot with amputation
Diabetic foot complications who have undergone lower-limb amputation
Measured: 10 years after diagnosed T2DM
Proliferative diabetic retinopathy
Advanced stage of diabetic retinopathy, marked by the formation of new blood vessels (neovascularization) on the retina or optic disc, which can lead to vitreous hemorrhage, tractional retinal detachment, and vision loss.
Measured: 10 years after diagnosed T2DM
Non-proliferative diabetic retinopathy
Early stage of diabetic retinal disease, characterized by microaneurysms, intraretinal hemorrhages, and hard exudates without the presence of neovascularization.
Measured: 10 years after diagnosed T2DM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2025
- Study start1 Jan 2010
- Primary completion30 Mar 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DisabilitiesStudies 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
- 365,295 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052708
- Sponsor's protocol ID
- MedicationAdherence_Disability
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Medication Adherence on Cardiovascular Outcomes in Individuals With Type 2 Diabetes and Disabilities: Nationwide Cohort Study
- ClinicalTrials.gov ID
- NCT07052708
- Acronym / sponsor ID
- MedicationAdherence_Disability
- Conditions
- Disabilities, Type 2 Diabetes
- Keywords
- medication adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365,295 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 6 Jul 2025 (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 disabilities and type 2 diabetes tend to have worse clinical outcomes. To identify modifiable factors that may improve these outcomes, the investigators evaluated the role of medication adherence. A retrospective, cohort study was conducted using data from the Korean National Health Insurance Service (K-NHIS) database.
Detailed description
Type 2 diabetes mellitus (T2DM) is a well-established risk factor for cardiovascular disease (CVD). In recent years, self-care has become a central component of diabetes management, with growing emphasis on medication adherence, physical activity, and lifestyle modifications to reduce CVD risk and improve long-term outcomes. As a result, limited capacity for self-care has been increasingly recognized as a major contributor to health disparities.
Approximately 25% of individuals with disabilities have T2DM, and those with physical or mental impairments often face substantial barriers to effective self-management. These challenges-including limited mobility and reduced access to health information-can lead to poor glycemic control and heightened cardiovascular risk.
However, most prior studies have primarily focused on describing the elevated risk of CVD in individuals with disabilities. Whether suboptimal medication adherence mediates the association between disability and cardiovascular outcomes remains unclear.
Therefore, this study aims to compare medication adherence between patients with and without disabilities and to assess whether differences in adherence contribute to disparities in the incidence of CVD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Disability | – | Behavioral: No adherence group, Behavioral: Adherence groupIndividuals were classified as having a disability if they were officially registered as of the index date. Physical disability included conditions such as limb impairment, brain lesion, visual or auditory impairment, speech impairment, facial disfigurement, and epilepsy. Mental disability included intellectual disability, autism spectrum disorder, and psychiatric disorders. |
| No disability | – | –Individuals who were not officially registered with any physical or mental disability as of the index date. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients newly diagnosed with T2DM and without prior major cardiovascular or malignant conditions.
Key inclusion criteria (1 listed)
- Patients who newly diagnosed T2DM between between January 1, 2010, and December 31, 2023
Key exclusion criteria (2 listed)
- individuals with a history of MI, stroke, percutaneous coronary intervention, peripheral arterial disease, chronic kidney disease, or cancer before the diagnosis of diabetes were excluded.
- individuals with who already had diabetics related complication
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 |
|---|---|---|
| No adherence groupPatients with poor adherence was defined as medication possession ratio(MPR) <50%. | Behavioural | Disability |
| Adherence groupPatients with good adherence was defined as medication possession ratio(MPR) ≥50%. | Behavioural | Disability |
Primary outcome
Major adverse cardiac and cerebrovascular events (MACCE)
Time frame: 10 years after diagnosed T2DM
Composite of MI, ischemic stroke, hemorrhagic stroke, and all-cause mortality
5 secondary outcomes
Diabetic neuropathy
Time frame: 10 years after diagnosed T2DM
Diabetic foot without amputation
Time frame: 10 years after diagnosed T2DM
Diabetic foot with amputation
Time frame: 10 years after diagnosed T2DM
Proliferative diabetic retinopathy
Time frame: 10 years after diagnosed T2DM
Non-proliferative diabetic retinopathy
Time frame: 10 years after diagnosed T2DM
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 10 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Disabilities and Type 2 Diabetes, run by Samsung Medical Center.
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 2 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 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Major adverse cardiac and cerebrovascular events (MACCE) (time frame: 10 years after diagnosed T2DM). 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 10 Jul 2025.