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
- Conditions
- Patients with type 2 diabetes using smartphone on a daily basis (including a person who newly visits to a clinic/hospital)
- Registration Number
- JPRN-UMIN000030823
- Lead Sponsor
- ational Center for Global Health and Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 1159
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method