UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025506 |
|---|---|
| Receipt number | R000029355 |
| Scientific Title | Glucose variability of FreeStyle Libre Flash Glucose Monitoring System in patients with diabetes in Japan |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2018/07/17 16:01:07 |
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Basic information
Public title
Glucose variability of FreeStyle Libre Flash Glucose Monitoring System in patients with diabetes in Japan
Acronym
Study of glucose variability using FreeStyle Libre
Scientific Title
Glucose variability of FreeStyle Libre Flash Glucose Monitoring System in patients with diabetes in Japan
Scientific Title:Acronym
Study of glucose variability using FreeStyle Libre
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare FreeStyle Libre Flash Glucose Monitoring System with existing glucose devices in patients with diabetes in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Daily glucose excursions, mean glucose, glucose standard deviation, MAGE, coefficient of variation by Libre and iPro2.
2)Blood glucose levels by Libre and existing blood glucose device.
Key secondary outcomes
Frequency of severe hypoglycemia, adverse events, questionnaire survey.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Diabetes in patient
2)Patients who gave written informed consent
Key exclusion criteria
1)Patients who have severe diabeticketosis, diabetic coma.
2)Patients with severe infections, severe injury or perioperative state.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Yamakawa |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
naibunpi@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Minori Shinoda |
Organization
Yokohama City University Medical Center
Division name
Department of Endocrinology and Diabetes
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
045-261-5656
Homepage URL
minoriorthomatsu@gmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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 | 01 | Month | 04 | 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
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2017 | Year | 01 | Month | 03 | Day |
Last modified on
| 2018 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029355
