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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041180082
Enrollment
100
Registered
2019-03-12
Start date
2017-07-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes

Interventions

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 p
D015190

Sponsors

Arima Hiroshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
HbA1c

Secondary

MeasureTime frame
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

Contacts

Public ContactTakeshi onoue

Nagoya University Hospital

t-onoue@med.nagoya-u.ac.jp+81-52-744-2142

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026