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The Impact of Medication Adherence in Patients With Type 2 Diabetes and Disabilities

Impact of Medication Adherence on Cardiovascular Outcomes in Individuals With Type 2 Diabetes and Disabilities: Nationwide Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07052708
Enrollment
365295
Registered
2025-07-06
Start date
2010-01-01
Completion date
2023-09-30
Last updated
2025-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disabilities, Type 2 Diabetes

Keywords

medication adherence

Brief 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. 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.

Interventions

BEHAVIORALNo adherence group

Patients with poor adherence was defined as medication possession ratio(MPR) \<50%.

BEHAVIORALAdherence group

Patients with good adherence was defined as medication possession ratio(MPR) ≥50%.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Patients who newly diagnosed T2DM between between January 1, 2010, and December 31, 2023

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Major adverse cardiac and cerebrovascular events (MACCE)10 years after diagnosed T2DMComposite of MI, ischemic stroke, hemorrhagic stroke, and all-cause mortality

Secondary

MeasureTime frameDescription
Diabetic neuropathy10 years after diagnosed T2DMNerve damage resulting from DM
Diabetic foot without amputation10 years after diagnosed T2DMDiabetic foot complications, such as ulcers, infections, or gangrene, without any lower-extremity amputation
Diabetic foot with amputation10 years after diagnosed T2DMDiabetic foot complications who have undergone lower-limb amputation
Proliferative diabetic retinopathy10 years after diagnosed T2DMAdvanced 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.
Non-proliferative diabetic retinopathy10 years after diagnosed T2DMEarly stage of diabetic retinal disease, characterized by microaneurysms, intraretinal hemorrhages, and hard exudates without the presence of neovascularization.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026