Unique ID issued by UMIN | UMIN000034162 |
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Receipt number | R000038946 |
Scientific Title | Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis |
Date of disclosure of the study information | 2018/09/15 |
Last modified on | 2020/11/12 18:10:19 |
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Comparison between iPro2 and LibrePro in hemodialysis
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Comparison between iPro2 and LibrePro in hemodialysis
Japan |
Patients on hemodialysis with/without diabetes
Endocrinology and Metabolism | Nephrology |
Others
NO
Comparison of accuracy between iPro2 and LibrePro in patients on hemodialysis
Safety,Efficacy
MARD(Mean Absolute Relative Difference)
Sensor glucose data
Relationship between sensor glucose data and diabetic markers
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Wearing 2 kinds of continuous glucose monitoring
20 | years-old | <= |
Not applicable |
Male and Female
Patients on hemodialysis agreed to this study
Subjects disagreed to this study
20
1st name | Akinori |
Middle name | |
Last name | Hayashi |
Kitasato University School of Medicine
Endocrinology, Diabetes and Metabolism
252-0374
1-15-1 Kitasato, Minami-ku, Sagamihara
0427788111
ahayashi@kitasato-u.ac.jp
1st name | Akinori |
Middle name | |
Last name | Hayashi |
Kitasato University School of Medicine
Endocrinology, Diabetes and Metabolism
252-0374
1-15-1 Kitasato, Minami-ku, Sagamihara
0427788111
ahayashi@kitasato-u.ac.jp
Kitasato University School of Medicine
Self funding
Self funding
Japan
Kitasato University Medical Ethics Organization, KMEO
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
0427788111
rinrib@med.kitasato-u.ac.jp
NO
2018 | Year | 09 | Month | 15 | Day |
https://www.sciencedirect.com/science/article/pii/S1056872720304426?via%3Dihub
Published
https://www.sciencedirect.com/science/article/pii/S1056872720304426?via%3Dihub
13
Overall, FGM and CGM were 95.4% and 98.9% within the Zone A+B of Parks Error Grid.
During HD, FGM and CGM were 86.9% and 95.0% within the Zone A+B.
The MARD for FGM was significantly higher than that for CGM.
2020 | Year | 11 | Month | 12 | Day |
2020 | Year | 07 | Month | 18 | Day |
Simultaneous FGM (FreeStyle LibrePro), CGM (iPro2) and SMBG were performed on 13 T2D research subjects.
Simultaneous FGM (FreeStyle LibrePro), CGM (iPro2) and SMBG were performed on 13 T2D research subjects.
The only adverse events identified during the entire study period were minor skin troubles in two patients, skin redness and slight skin itchy on the site of FGM, and dropped-off FGM in only one patient.
There were good overall correlations between SMBG and FGM (64.7% and 30.8% within the A and B of Parkes Error Grid, respectively) and between SMBG and CGM (87.9% and 11.0% within the A and B, respectively). However, during HD, correlations between SMBG and FGM were only 49.7% and 37.2% within the A and B, respectively, while correlations of SMBG and CGM were 72.8% and 22.2% within the A and B, respectively. The percentage of FGM not in Zone A + B was more than 4 times higher than for CGM. The overall mean absolute relative difference (MARD) for FGM was 18.2%, this significantly higher than 11.2% for CGM. During HD, MARD for FGM was 22.8%, significantly higher than 15.0% for CGM.
Main results already published
2018 | Year | 09 | Month | 12 | Day |
2018 | Year | 09 | Month | 12 | Day |
2018 | Year | 09 | Month | 12 | Day |
2019 | Year | 09 | Month | 01 | Day |
2020 | Year | 03 | Month | 17 | Day |
2020 | Year | 03 | Month | 17 | Day |
2020 | Year | 03 | Month | 17 | Day |
2018 | Year | 09 | Month | 15 | Day |
2020 | Year | 11 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000038946
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