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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000026963
Receipt No. 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

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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
Email 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
Email ymori-metab@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030923

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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