Unique ID issued by UMIN | UMIN000026452 |
---|---|
Receipt number | R000030387 |
Scientific Title | Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients |
Date of disclosure of the study information | 2017/03/10 |
Last modified on | 2024/03/12 14:07:33 |
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
Study of the impact of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Japan |
Type 2 Diabetes
Endocrinology and Metabolism |
Others
NO
To explore the effects of the Flash Glucose Monitoring System(FGM) on glycometabolism of type 2 diabetic patients
Efficacy
HbA1c
glucose cariability
patient satisfaction
blood pressure
body weight
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Device,equipment |
Encourage to improve life style by using Flash glucose monitoring system(FGM)
Encourage to improve life style by using conventional device for self measurement of blood glucose(SMBG)
20 | years-old | <= |
70 | years-old | >= |
Male and Female
Type 2 diabetes mellitus
HbA1c 7.5% or more and less than 8.5%
Diabetic nephropathy (eGFR<30ml/min/1.73m2)
Dialysis patient
Receiving insulin therapy
Proliferative diabetic retinopathy or preproliferative retinopathy
Subjects who can not properly operate the device to be used
100
1st name | Hiroshi |
Middle name | |
Last name | Arima |
Nagoya University Graduate School of Medicine
Endocrinology and Diabetes
466-8550
65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
052-744-2142
arima105@med.nagoya-u.ac.jp
1st name | Motomitsu |
Middle name | |
Last name | Goto |
Nagoya University Graduate School of Medicine
Endocrinology and Diabetes
466-8550
65 Tsurumai-Cho,Showa-ku,Nagoya,Japan
052-744-2142
goto@med.nagoya-u.ac.jp
Nagoya University
Unsettled
Other
the Ethical Committee of the Nagoya University Hospital
65 tsurumai-cho, showa-ku, Nagoya, Aichi
052-744-2973
ethics@med.nagoya-u.ac.jp
NO
2017 | Year | 03 | Month | 10 | Day |
https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf
Partially published
https://drc.bmj.com/content/bmjdrc/8/1/e001115.full.pdf
100
The mean HbA1c levels were 7.83% in the FGM group and 7.84% in the SMBG group at baseline, and the values were reduced in both FGM (-0.43%) and SMBG groups (-0.30%) at 12 weeks. On the other hand, HbA1c was significantly decreased from baseline values in the FGM group, but not in the SMBG group at 24 weeks (FGM, -0.46% SMBG, -0.17%);a significant between-group difference was also observed (difference -0.29%).
2020 | Year | 09 | Month | 12 | Day |
Patients with non-insulin-treated type 2 diabetes at five hospitals in Japan were eligible for inclusion if they HbA1c more than or equal to 7.5% (59 mmol/mol) and <8.5% (69 mmol/mol).
Patients were randomly assigned to the FGM (n=49) or SMBG (n=51) groups and were provided each device for 12 weeks.
None of the severe adverse events was related to the device or study procedure.
The primary outcome was change in glycated hemoglobin (HbA1c) level.
Completed
2017 | Year | 03 | Month | 10 | Day |
2017 | Year | 06 | Month | 20 | Day |
2017 | Year | 06 | Month | 20 | Day |
2019 | Year | 05 | Month | 18 | Day |
2017 | Year | 03 | Month | 07 | Day |
2024 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030387
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |