UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053595 |
|---|---|
| Receipt number | R000060818 |
| Scientific Title | Effectiveness of Free Style Libre by changing Libre 2 in Japanese diabetic patients |
| Date of disclosure of the study information | 2024/02/14 |
| Last modified on | 2024/02/11 00:07:12 |
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Basic information
Public title
Effectiveness of Free Style Libre by changing Libre 2 in Japanese diabetic patients
Acronym
Effectiveness of Free Style Libre by changing Libre 2 in Japanese diabetic patients
Scientific Title
Effectiveness of Free Style Libre by changing Libre 2 in Japanese diabetic patients
Scientific Title:Acronym
Effectiveness of Free Style Libre by changing Libre 2 in Japanese diabetic patients
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effeicacy, safety and satisfaction of Libre2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpont was the changes in TIR, TBR and insulin unit from baseline to 16weeks.
Key secondary outcomes
The secondary endpont was the changes in TAR, average glucose level, GMI, %CV, body weight,HbA1c and satisfaction of DTSQ from baseline to 16weeks
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Diabetic patients using Freestyle Libre
Key exclusion criteria
Patients who don`t agree to participate in clinical study
Determined to be ineligible by the physician in charge for any other reason
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hajime |
| Middle name | |
| Last name | Maeda |
Organization
HEC Science Clinic
Division name
internal medicine
Zip code
2350045
Address
4-1-4-102, Yokodai, Yokohama-Shi Isogo-Ku, Kanagawa, JAPAN
TEL
0458310031
hec@asahi-net.email.ne.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Maeda |
Organization
HEC Science Clinic
Division name
internal medicine
Zip code
2350045
Address
4-1-4-102, Yokodai, Yokohama-Shi Isogo-Ku, Kanagawa, JAPAN
TEL
0458310031
Homepage URL
hec@asahi-net.email.ne.jp
Sponsor or person
Institute
HEC Science Clinic
Institute
Department
Personal name
Funding Source
Organization
HEC Science Clinic
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
HEC Science Clinic
Address
4-1-4-102, Yokodai, Yokohama-Shi Isogo-Ku, Kanagawa, JAPAN
Tel
0458310031
hec@asahi-net.email.ne.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
| 2024 | Year | 02 | Month | 14 | 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
| 2023 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observation study
Management information
Registered date
| 2024 | Year | 02 | Month | 11 | Day |
Last modified on
| 2024 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060818
