A randomised controlled clinical study to evaluate the efficacy and quality of life of structured self glucose monitoring in non-insulin treated type 2 diabetes mellitus patients in Japa

Not Applicable

• Conditions: type 2 diabetes mellitus

• Registration Number: JPRN-UMIN000008480
• Lead Sponsor: Keio University school of medicine, Nephrology, endocrinology, and metabolism department

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-20
• Study Completion: 2016-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Already treated by insulin Already performed SMBG Who cannot perform SMBG by some reason like dementia Pregnant Who have such diseases which affect the values of Hba1c as end-stage renal disease, liver cirrhosis, thyroid disease, and hematological disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HbA1c after 6 months and 12months

Secondary Outcome Measures

Name	Time	Method
glycoalbumin after 6 months and 12months change of glycoalbumin/HbA1c ratio after 6 months and 12months change of BMI ratio after 6 months and 12months change of QOL after 6 months and 12months frequency and pattern of severe hypoglycemia frequency and pattern of fasting/postprandial hyperglycemia opinions against Accu-Chek® 360 from study subjects and medical stuffs