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

Completed

• Conditions: Disabilities; Type 2 Diabetes

• Registration Number: NCT07052708
• Lead Sponsor: Samsung Medical Center

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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2023-03-30
• Study Completion: 2023-09-30
• Study First Submitted: 2025-06-28
• Study First Submitted QC: 2025-06-28
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-05
• Study First Posted: 2025-07-06
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365295

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major adverse cardiac and cerebrovascular events (MACCE)	10 years after diagnosed T2DM	Composite of MI, ischemic stroke, hemorrhagic stroke, and all-cause mortality

Secondary Outcome Measures

Name	Time	Method
Diabetic neuropathy	10 years after diagnosed T2DM	Nerve damage resulting from DM
Diabetic foot with amputation	10 years after diagnosed T2DM	Diabetic foot complications who have undergone lower-limb amputation
Proliferative diabetic retinopathy	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.
Non-proliferative diabetic retinopathy	10 years after diagnosed T2DM	Early stage of diabetic retinal disease, characterized by microaneurysms, intraretinal hemorrhages, and hard exudates without the presence of neovascularization.
Diabetic foot without amputation	10 years after diagnosed T2DM	Diabetic foot complications, such as ulcers, infections, or gangrene, without any lower-extremity amputation