The COMparison of satisfaction between patient-led and physician-led titration groups Measured by QOL and self-efficacy scores In Japanese T2D patients study
- Conditions
- Type 2 diabetes
- Registration Number
- JPRN-UMIN000020316
- Lead Sponsor
- Japan society for Patient Reported Outcome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 250
Not provided
Patients who fall into any of the following criteria are excluded from participating in the study. 1. Patients with dementia or possibly with dementia, or with psychological illness 2. Unable to make judgement for themselves, or incapable of reading and writing 3. Need a proxy's consent to join the study 4. With visual impairment which interferes with self-injection 5. Have an experience of using GLP-1 or insulin in the past 6. Currently on systemic steroid, beta-blocker, monoamine oxidase, etc., that may have an influence on glycemic control 7. If insulin is contradicted to use, or needs to be carefully used 8. Have an experience of myocardial infarction, angina, stroke, or cerebral infarction within 6 months before the baseline 9. With liver failure (ALT is doubled or higher than that of the upper limit in healthy individuals) 10. With renal impairment (SCr is 125 mumol/L or higher (1.4 mg/dL or higher) among men, and is 110 mumol/L or higher (1.3 mg/dL or higher) among women 11. Possibly pregnant or pregnant, or plant to be pregnant during the study period 12. Currently have malignancy, or had it in the past 13. Any condition that physicians think to be inappropriate to join the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amount of changes in scores of PAID (The Problem Areas In Diabetes Scale) from baseline to the 24th week
- Secondary Outcome Measures
Name Time Method