UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026963 |
|---|---|
| Receipt number | R000030923 |
| Scientific Title | Efficacy of flash glucose monitoring system, FreeStyle Libre in capturing hypoglycemia, hyperglycemia and blood glucose control |
| Date of disclosure of the study information | 2017/04/12 |
| Last modified on | 2017/04/12 16:52:59 |
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Basic information
Public title
Efficacy of flash glucose monitoring system, FreeStyle Libre in capturing hypoglycemia, hyperglycemia and blood glucose control
Acronym
Efficacy of flash glucose monitoring system, FreeStyle Libre
Scientific Title
Efficacy of flash glucose monitoring system, FreeStyle Libre in capturing hypoglycemia, hyperglycemia and blood glucose control
Scientific Title:Acronym
Efficacy of flash glucose monitoring system, FreeStyle Libre
Region
| Japan |
Condition
Condition
Diabetes Melitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of glucose monitoring with FreeStyle Libre in capturing hypoglycemia, hyperglycemia and blood glucose control compared with SMBGs and CGMs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
HbA1c
GA
frequency of hypoglycemia(blood glucose<70mg/dl, 50mg/dl, sensor glucose<70mg/dl, 50mg/dl)
Percentage of hypoglycemia(AUC area under the curve)
Key secondary outcomes
Percentage of target glucose range(70-180mg/dl)(AUC)
frequency of SMBGs
frequency of hyperglycemia(blood glucose>250mg/dl, sensor glucose>250mg/dl)
variables of blood glucose (CV: confficient of variation, MAGE: mean amplitude of glycemic excursions, CONGA: continuous overall net glycemic action)
Change in QOL of patients based on results of questionnaire DTR-QOL
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
FreeStyle Libre
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
Diabetic patients who monitors blood glucose more than 7 times a week.
Patients aged over 20 who agree with this research.
Patients with any types of diabetes mellitus
Key exclusion criteria
1)patients who are not able to communicate with other people
2)patients judged inappropriate to participate in this research by doctors.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasumichi Mori |
Organization
Toranomon Hospital
Division name
Department of Endocrinology and Metabolism (Metabolism Division)
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470
TEL
03-3588-1111
ymori-metab@toranomon.gr.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasumichi Mori |
Organization
Toranomon Hospital
Division name
Department of Endocrinology and Metabolism (Metabolism Division)
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470
TEL
03-3588-1111
Homepage URL
ymori-metab@toranomon.gr.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 04 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 04 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 11 | 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 | 04 | Month | 12 | Day |
Last modified on
| 2017 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030923
