UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035996 |
|---|---|
| Receipt number | R000040971 |
| Scientific Title | Performance evaluation of the blood sugar self measuring instrument |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2019/03/26 09:44:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Performance evaluation of the blood sugar self measuring instrument
Acronym
Performance evaluation of the blood sugar self measuring instrument
Scientific Title
Performance evaluation of the blood sugar self measuring instrument
Scientific Title:Acronym
Performance evaluation of the blood sugar self measuring instrument
Region
| Japan |
Condition
Condition
Diabetes Mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Performance evaluation of the new blood sugar self measuring instrument
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conformity to ISO15197 standard
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who understand the purpose of the research
Key exclusion criteria
Subjects who are infected by HBV, HCV, HIV, Syphilis, etc.
Subjects who have symptom of anemia.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tomoko |
| Middle name | |
| Last name | Hasunuma |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research, Clinical Trial Center
Zip code
108-8642
Address
5-9-1 Shirogane, Minato-ku, Tokyo
TEL
03-5791-6350
t-hasu@insti.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Hasunuma |
Organization
Kitasato University Kitasato Institute Hospital
Division name
Department of Research, Clinical Trial Center
Zip code
108-8642
Address
5-9-1 Shirogane, Minato-ku, Tokyo
TEL
03-5791-6350
Homepage URL
t-hasu@insti.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University Kitasato Institute Hospital
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Kitasato Institute Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kitasato University Kitasato Institute Hospital
Address
5-9-1 Shirogane, Minato-ku, Tokyo
Tel
03-5791-6350
irb-pt@insti.kitasato-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
122
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 02 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040971
