Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J): A multicenter, randomized, open-label, parallel group study - Prevention of Worsening Diabetes through Behavioral Changes by an IoT-based Self-Monitoring System in Japan (PRISM-J)

ational Center for Global Health and Medicine0 个研究点目标入组 1,159 人开始时间: 2018年1月16日最近更新: 2023年10月17日

适应症

试验速览

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•1. A patient with serious hepatic impairment (his/her ALT exceeds 3-fold of the upper limit of the standard value), kidney diseases (his/her eGFR is less than 30 mL/min/1.73 m2), malignancies (patient whose time to recurrence is less than 5 years), or active infectious diseases (including sepsis). 2. A patient receiving 4 or more oral therapeutic agents for diabetes. 3. A patient receiving any insulin or GLP1 receptor agonist. 4. A patient with active proliferative diabetic retinopathy. 5. A patient who had developed cardiovascular disease within 6 months. 6. A patient with an uncompensated cardiac insufficiency. 7. A patient who is pregnant or is planning to become pregnant within 2 years. 8. A patient who requires assistance from another person to treat hypoglycemia. 9. A patient who is instructed to follow the exercise restrictions due to diseases other than diabetes mellitus. 10. A patient for whom the person in charge of the study judges that his/her participation in this study is inappropriate.

发起方

ational Center for Global Health and Medicine