Study on a program for prevention of aggravation of diabetes: effectiveness of behavior modification model using Internet of Things including interventions by multiple types of professionals
- Conditions
- Diabetes/pre-diabetes
- Registration Number
- JPRN-UMIN000035077
- Lead Sponsor
- agoya Station Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 105
Not provided
1. Having comorbidity of severe hepatic dysfunction (3 times or more of upper limit of reference value for AST or ALT), hemodialysis, or comorbidity of cancer 2. Receiving treatment with insulin 3. In pregnancy or planning to get pregnant 4. Being restricted exercise 5. Having cognitive dysfunction 6. Having serious cardiovascular diseases (myocardial infarct, angina, serious arrhythmia, hypertension with a systolic blood pressure 180 mmHg or more or with a diastolic blood pressure 110 mmHg or more) 7. Being deemed inappropriate to participate to this study by his/her primary physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in hemoglobin (Hb) A1c at 12 and 24 weeks from baseline
- Secondary Outcome Measures
Name Time Method 1. Change in body weight (body mass index) at 12 and 24 weeks from baseline 2. Change in abdominal girth at 12 and 24 weeks from baseline 3. Change in blood pressure at 12 and 24 weeks from baseline 4. Change in blood test values (fasting blood glucose, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) at 12 and 24 weeks from baseline 5. Change in lifestyle behavior and depression status based on questionnaires at 24 weeks from baseline 6. Monthly change in exercise behavior based on recorded number of steps