Pragmatic Randomized Clinical Trial of a Personalized RIsk Score–Based ManagEment Strategy in Older Adults with Type 2 Diabetes Mellitus (PRIME-DM)

The Catholic University of Korea, St. Vincent's Hospital0 个研究点目标入组 1,198 人开始时间: 2026年8月4日最近更新: 2026年8月3日

适应症

试验速览

暂无简介。

•Diagnosis of type 1 diabetes mellitus.
•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.
•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.
•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.
•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.
•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.

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