Unique ID issued by UMIN | UMIN000042667 |
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Receipt number | R000048682 |
Scientific Title | Comparison of calibration accuracy between point-of-care devices and glucometers when using personal CGM |
Date of disclosure of the study information | 2020/12/06 |
Last modified on | 2021/06/07 09:36:21 |
Comparison of calibration accuracy between point-of-care devices and glucometers when using personal CGM
Comparison of calibration accuracy between point-of-care devices and glucometers
Comparison of calibration accuracy between point-of-care devices and glucometers when using personal CGM
Comparison of calibration accuracy between point-of-care devices and glucometers
Japan |
type 2 diabetes
Endocrinology and Metabolism |
Others
NO
To investigate calibration accuracy between point-of-care devices (POCT) and glucometers that were compliant with ISO15197:2013 (ISO) when using personal CGM
Safety,Efficacy
MARD for POCT and SMBG when using venous blood glucose levels (n = 48)
Interventional
Cross-over
Randomized
Individual
Open -no one is blinded
Active
2
Prevention
Device,equipment |
Study participants are 24 patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. We evaluate pre-prandial and bedtime glucose levels on days 2 to 5 of wearing the CGM devices, in addition, we also evaluate postprandial glucose levels on days 2 and 5. POCTSMBG group: days 2 and 3: POCT, days 4 and 5: ISO. Calibration is performed using venous blood glucose levels at pre- and post-breakfast on days 2-5, and that is performed using capillary blood glucose levels at the others.
Study participants are 24 patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. We evaluate pre-prandial and bedtime glucose levels on days 2 to 5 of wearing the CGM devices, in addition, we also evaluate postprandial glucose levels on days 2 and 5. SMBGPOCT group: days 2 and 3: ISO, days 4 and 5: POCT. Calibration is performed using venous blood glucose levels at pre- and post-breakfast on days 2-5, and that is performed using capillary blood glucose levels at the others.
20 | years-old | <= |
90 | years-old | > |
Male and Female
patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days.
judged to be unsuitable for participation for medical reasons
24
1st name | Soichi |
Middle name | |
Last name | Takeishi |
Inuyama Chuo General Hospital
Diabetes
484-8511
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568628111
souichi19811225@yahoo.co.jp
1st name | Soichi |
Middle name | |
Last name | Takeishi |
Inuyama Chuo General Hospital
Diabetes
484-8511
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
Inuyama Chuo General Hospital
Inuyama Chuo General Hospital
Self funding
Inuyama Chuo General Hospital
6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
0568-62-8111
souichi19811225@yahoo.co.jp
NO
2020 | Year | 12 | Month | 06 | Day |
Unpublished
16
Completed
2020 | Year | 08 | Month | 15 | Day |
2020 | Year | 12 | Month | 04 | Day |
2020 | Year | 12 | Month | 06 | Day |
2021 | Year | 07 | Month | 31 | Day |
2020 | Year | 12 | Month | 06 | Day |
2021 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048682
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