NCT07052708

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365,295

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
13.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 6, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

13.2 years

First QC Date

June 28, 2025

Last Update Submit

July 5, 2025

Conditions

Keywords

medication adherence

Outcome Measures

Primary Outcomes (1)

  • Major adverse cardiac and cerebrovascular events (MACCE)

    Composite of MI, ischemic stroke, hemorrhagic stroke, and all-cause mortality

    10 years after diagnosed T2DM

Secondary Outcomes (5)

  • Diabetic neuropathy

    10 years after diagnosed T2DM

  • Diabetic foot without amputation

    10 years after diagnosed T2DM

  • Diabetic foot with amputation

    10 years after diagnosed T2DM

  • Proliferative diabetic retinopathy

    10 years after diagnosed T2DM

  • Non-proliferative diabetic retinopathy

    10 years after diagnosed T2DM

Study Arms (2)

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.

Behavioral: No adherence groupBehavioral: Adherence group

No disability

Individuals who were not officially registered with any physical or mental disability as of the index date.

Interventions

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

Disability
Adherence groupBEHAVIORAL

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

Disability

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients newly diagnosed with T2DM and without prior major cardiovascular or malignant conditions.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 28, 2025

First Posted

July 6, 2025

Study Start

January 1, 2010

Primary Completion

March 30, 2023

Study Completion

September 30, 2023

Last Updated

July 10, 2025

Record last verified: 2025-07