Study of the impact of the Flash Glucose Monitoring System"FGM"on glycometabolism of type 2 diabetic patients

JRCT ID: jRCTs041180082

Registered date:12/03/2019

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: type 2 diabetes
• Date of first enrollment: 04/07/2017
• Target sample size: 100
• Study type: Interventional
• Intervention(s): All participants wore a sensor(Free Style Libre Pro) more than 7-day baseline period, during this phase sensor glucose measurements were blinded (not visible) to participants and investigators. Then participants were randomized in a 1:1 ratio to sensor-based flash glucose monitoring group(intervention group) or to self-monitoring of blood glucose group(control group) . Intervention participants used a sensor-based flash glucose monitoring system (Free Style Libre) and control participants used a blood glucose monitoring device(Free Style Precision Neo) for 3 months.

Outcome(s)

• Primary Outcome: HbA1c

Secondary Outcome

Body weight, blood pressure, change of antidiabetic agent, fasting blood glucose, Lipid (total cholesterol, LDL, HDL, TG), uric acid, urinary albumin.
The Diabetes Treatment Satisfaction Questionnaire (DTSQ) at 3 month endpoint
Data of glucose fluctuations at baseline and 3 months endpoint obtained from FGM
Measurement frequency of FGM and SMBG, measurement time
Adverse event
Relationship between glucose fluctuations data at baseline obtained from FGM and characteristics of participants
Exploratory study: Relationship between patient background / clinical indicators and intervention effect

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Arima Hiroshi