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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000029673
Receipt No. R000033908
Scientific Title Patient satisfaction and clinical efficacy of the flash glucose monitoring in the patients with type 1 diabetes
Date of disclosure of the study information 2017/10/25
Last modified on 2019/04/25

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Basic information
Public title Patient satisfaction and clinical efficacy of the flash glucose monitoring in the patients with type 1 diabetes
Acronym Patient satisfaction of the FGM in T1D
Scientific Title Patient satisfaction and clinical efficacy of the flash glucose monitoring in the patients with type 1 diabetes
Scientific Title:Acronym Patient satisfaction of the FGM in T1D
Region
Japan

Condition
Condition Type 1 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess patient satisfaction of the FGM in the patients with type 1 diabetes
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the DTSQ scores before and 4 weeks after FGM use
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 Patients use the FGM (FreeStyle Libre) for 12weeks.
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
18 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1. Type 1 diabetes
2. Age: 18 to 75 years old
Key exclusion criteria 1. Hypersensitivity to medical patches
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Daisuke
Middle name
Last name Chujo
Organization National Center for Global Health and Medicine
Division name Department of Diabetes, Endocrinology, and Metabolism
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Email dchujo@hosp.ncgm.go.jp

Public contact
Name of contact person
1st name Daisuke
Middle name
Last name Chujo
Organization National Center for Global Health and Medicine
Division name Department of Diabetes, Endocrinology, and Metabolism
Zip code 162-8655
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
TEL 03-3202-7181
Homepage URL
Email dchujo@hosp.ncgm.go.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Institutional Review Board of National Center for Global Health and Medicine
Address 1-21-1, Toyama, Shinjuku, Tokyo, Japan
Tel 03-3202-7181
Email rinrijm@hosp.ncgm.go.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
2017 Year 10 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 22
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 No longer recruiting
Date of protocol fixation
2017 Year 01 Month 23 Day
Date of IRB
2017 Year 01 Month 23 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 23 Day
Last modified on
2019 Year 04 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033908

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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