UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029673 |
|---|---|
| Receipt number | 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 | 2019/10/25 12:16:15 |
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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
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
dchujo@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine
Institute
Department
Personal name
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
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
Completed
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 | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033908
