Study of the impact of the Flash Glucose Monitoring SystemFGMon glycometabolism of type 2 diabetic patients
Not Applicable
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-jRCTs041180082
- Lead Sponsor
- Arima Hiroshi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Outpatiants with type 2 diabetes whose HbA1c is 7.5% or more and less than 8.5%
Aged 20 years or older and under 70
No serious diabetic complications
Agreed with the protocol of this study.
Exclusion Criteria
Dialysis patients
Patients treated with insulin therapy
Patients conducting self-blood glucose measurement
Patients with diabetic nephropathy phase 4 or higher
Patients with diabetic retinopathy more than pre-proliferative retinopathy
Patients who can not properly operate the device
Patient judged inappropriate for participation in this study by doctors
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c
- Secondary Outcome Measures
Name Time Method Body weight, blood pressure, change of antidiabetic agent, fasting blood glucose, Lipid (total cholesterol, LDL, HDL, TG), uric acid, urinary albumin.<br>The Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 month endpoint<br>Data of glucose fluctuations at baseline and 3 months endpoint obtained from FGM <br>Measurement frequency of FGM and SMBG, measurement time<br>Adverse event<br>Relationship between glucose fluctuations data at baseline obtained from FGM and characteristics of participants <br>Exploratory study: Relationship between patient background / clinical indicators and intervention effect