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Effect of Intermittent-Scanning Continuous Glucose Monitoring to Glycemic Control Including Hypoglycemia and Quality of Life of Patients with Type 1 Diabetes Mellitus Study

Not Applicable
Conditions
Type 1 diabetes mellitus
Registration Number
JPRN-jRCT1052180075
Lead Sponsor
Murata Takashi
Brief Summary

The use of intermittently scanned continuous glucose monitoring accompanied by structured education reduced the time below range compared with self-monitoring of blood glucose.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
104
Inclusion Criteria

Type 1 diabetes mellitus

Exclusion Criteria

Pregnant woman

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Decrease in time in hypoglycemia per day (hour/day)
Secondary Outcome Measures
NameTimeMethod
Body weight, types of prescribed insulin, total daily dose of prescribed insulin, total daily dose of prescribed basal insulin, frequency of injection of prescribed insulin, glycoalbumin, mean sensor glucose levels, frequency of severe hypoglycemia, indexes for glucose fluctuation [ADRR, MODD, LBGI, TIR(70-180 mg/dl), TAR(>180 mg/dl)], emotional burden of diabetes (PAID), fear of hypoglycemia (HFS), frequency of SMBG (measured), usage of FGM, MARD, MAD, frequency of hypoglycemia per month, hypoglycemia unawareness, index for medical economics (CER, ICER, QALY), severe adverse event (SAE), adverse event (AE).
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