Unique ID issued by UMIN | UMIN000015730 |
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Receipt number | R000018303 |
Scientific Title | New "MEDISAFE FIT Smile Blood Glucose Meter" effectiveness evaluation for Experiencer |
Date of disclosure of the study information | 2014/11/21 |
Last modified on | 2015/11/19 11:03:27 |
New "MEDISAFE FIT Smile Blood Glucose Meter" effectiveness evaluation for Experiencer
New "MEDISAFE FIT Smile Blood Glucose Meter" effectiveness evaluation for Experiencer
New "MEDISAFE FIT Smile Blood Glucose Meter" effectiveness evaluation for Experiencer
New "MEDISAFE FIT Smile Blood Glucose Meter" effectiveness evaluation for Experiencer
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism |
Others
NO
A function and characteristic of new blood sugar self measuring instrument 'MEDISAFE Fit Smile' promotes consciousness improvement, action transformation of communication improvement between a patient and medical personnel and patient oneself in comparison with the product 'MEDISAFE Fit' conventionally and performs the inspection that is effective for the improvement of the blood sugar index.
Safety,Efficacy
Exploratory
Pragmatic
Not applicable
Comparison of the questionnaire result
PPG,GA,HbA1c,BMI,Biochemical examination of blood
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Subjets Use 'Medisafe Fit Smile'
Not applicable |
Not applicable |
Male and Female
1)The patient who measures blood sugar before an evaluation start
2)Type 2 patient of the stagnation period (in HbA1c 8.0-9.0% around one year)
3)The patient with the intention of the lifestyle improvement before an evaluation start
4)The patient who self-injects insulin
1)Type 1 diabetes mellitus
2)The patient who has difficulty in understanding of the blood sugar meter by cognitive ability or eyesight drop
3)In addition, the patient whom it was judged an evaluation PI or sub-PI to be unsuitable for evaluation participation
20
1st name | |
Middle name | |
Last name | Takeshi Osonoi |
Nakakinen clinic
Director
745-5,Nakadai,Naka-city,Ibaraki,311-0113,JAPAN
029-353-2800
t-osonoi@kensei-kai.com
1st name | |
Middle name | |
Last name | Kensuke Ofuchi |
Nakakinen clinic
Clinical laboratory
745-5,Nakadai,Naka-city,Ibaraki,311-0113,JAPAN
029-353-2800
k-ofuchi@kensei-kai.com
Terumo Corporation
NONE
Self funding
NO
那珂記念クリニック(茨城県)
2014 | Year | 11 | Month | 21 | Day |
Unpublished
Completed
2014 | Year | 10 | Month | 17 | Day |
2014 | Year | 11 | Month | 10 | Day |
2015 | Year | 08 | Month | 31 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 09 | Month | 30 | Day |
2015 | Year | 11 | Month | 19 | Day |
2014 | Year | 11 | Month | 21 | Day |
2015 | Year | 11 | Month | 19 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018303
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