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OpenTrials
Completed

NCT Number: NCT07052708

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

No adherence group

Behavioral

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

Adherence group

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Diabetic neuropathy

    Time frame: 10 years after diagnosed T2DM

    Nerve damage resulting from DM

  2. Diabetic foot without amputation

    Time frame: 10 years after diagnosed T2DM

    Diabetic foot complications, such as ulcers, infections, or gangrene, without any lower-extremity amputation

  3. Diabetic foot with amputation

    Time frame: 10 years after diagnosed T2DM

    Diabetic foot complications who have undergone lower-limb amputation

  4. Proliferative diabetic retinopathy

    Time frame: 10 years after diagnosed T2DM

    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.

  5. Non-proliferative diabetic retinopathy

    Time frame: 10 years after diagnosed T2DM

    Early stage of diabetic retinal disease, characterized by microaneurysms, intraretinal hemorrhages, and hard exudates without the presence of neovascularization.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2023
Study completion
2023
First posted
Jul 6, 2025
Registry last updated
Jul 10, 2025

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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