None listed
Conditions
Interventions
Behavioral : Participants are stratified into low-risk and high-risk groups according to a health risk score and randomized 1:1 to the intervention or control group within each risk stratum. The inter
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Men and women aged 65 years or older.
Exclusion criteria
Exclusion criteria: 1) Diagnosis of type 1 diabetes mellitus. 2) Low-risk group only: Receiving insulin therapy other than once-daily basal insulin, including basal-plus, premixed insulin, basal-bolus insulin regimens, or insulin pump therapy. 3) History of an acute cardiovascular event within 3 months prior to screening, including acute coronary syndrome, coronary or peripheral revascularization, ischemic stroke, or hemorrhagic stroke. 4) Conditions that may compromise the reliability of HbA1c measurement, including but not limited to severe or chronic anemia, treatment with erythropoiesis-stimulating agents, hematologic disorders, or blood transfusion within the previous 3 months. 5) Receipt of an investigational medicinal product or application of an investigational medical device in another interventional clinical trial within 4 weeks prior to the screening visit. Participants enrolled in a post-marketing surveillance (PMS) study, an observational study, or another clinical study that, in the investigator's judgment, does not affect participant safety or the interpretation of the study results may be enrolled. 6) Any condition that, in the investigator's judgment, makes the participant unsuitable for study participation, including but not limited to anticipated difficulty with long-term follow-up (e.g., overseas residence or planned transfer of care), limited life expectancy, or poor treatment adherence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to diabetes-related composite event (death, major macrovascular events, renal events, retinal events, or diabetes-related hospitalization). | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of diabetes-related composite event (death, major macrovascular events, renal events, retinal events, or diabetes-related hospitalization) | — |
Countries
Korea, Republic of
Contacts
Public ContactKYEONGMIN LEE
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed