UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028412 |
|---|---|
| Receipt number | R000032517 |
| Scientific Title | Study about the discrepancies between monitoring data of FreeStyle libre and SMBG. |
| Date of disclosure of the study information | 2017/07/27 |
| Last modified on | 2018/07/28 20:51:39 |
* 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
Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Acronym
Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Scientific Title
Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Scientific Title:Acronym
Study about the discrepancies between
monitoring data of FreeStyle libre and SMBG.
Region
| Japan |
Condition
Condition
healthy subjects
patients with diabetes, using insulin
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the discrepancies of monitoring
data between FreeStyle libre and SMBG, to use
the device properly.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The level of discrepancies of monitoring
data between FreeStyle libre and SMBG.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To evaluate the discrepancies among the
glucose data of libre, SMBG and venous blood
sample(at OGTT only for healthy subjects).
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Agreemnt with paper.
2.Healthy subjects.
Patients with diabetes using insulin.
Key exclusion criteria
1.Subjects with renal dysfunction
(>=Cr1.5mg/dl)and liver dysfunction
(ex.cirrhosis).
2.Inappropriate for the research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Junko Sato |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL
055-948-3111
jsato@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junko Sato |
Organization
Juntendo University Shizuoka Hospital
Division name
Department of Diabetes, Endocrinology and Metabolism
Zip code
Address
1129 Nagaoka, Izunokunishi, Shizuoka, Japan
TEL
055-948-3111
Homepage URL
jsato@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Shizuoka Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Shizuoka Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2017 | Year | 03 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 07 | Month | 27 | Day |
Last modified on
| 2018 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032517
