UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054616 |
|---|---|
| Receipt number | R000062253 |
| Scientific Title | Effect of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre: A Prospective Single-Center Observational Study |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2024/08/16 09:21:43 |
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Basic information
Public title
Effect of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre: A Prospective Single-Center Observational Study
Acronym
Effect of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre: A Prospective Single-Center Observational Study
Scientific Title
Effect of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre: A Prospective Single-Center Observational Study
Scientific Title:Acronym
Effect of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre: A Prospective Single-Center Observational Study
Region
| Japan |
Condition
Condition
persons with diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effects of Freestyle Libre 2 on hypoglycemia and psychological aspects in persons with diabetes mellitus with Freestyle Libre
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Time range of glucose below 70 mg/dl after 12 weeks starting Freestyle Libre 2
Key secondary outcomes
Effects of Freestyle Libre 2 on psychological aspects, Time in range of glucose from 70 to 180 mg/dl, Time range of glucose above 180 mg/dl
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
persons with diabetes mellitus treated with Freestyle Libre
1) patients using Libre link (Abott Japan, Tokyo, Japan), a smart phone application, as a reader to scan glucose level
2) patients capable of giving written consent
Key exclusion criteria
patients who were regarded as inappropriate by the physicians
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akiyama |
| Middle name | |
| Last name | Tomoaki |
Organization
Yokohama city University Medical Center
Division name
Endocrinology Diabetes and Metabolism
Zip code
2320024
Address
4-57, Urafune-cho, Minami-ku, Yokohama city
TEL
0452615656
t_aki85@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akiyama |
| Middle name | |
| Last name | Tomoaki |
Organization
Yokohama city University Medical Center
Division name
Endocrinology Diabetes and Metabolism
Zip code
2320024
Address
4-57, Urafune-cho, Minami-ku, Yokohama city
TEL
0452615656
Homepage URL
t_aki85@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
3-9, Fukuura, Kanazawa-ku, Yokohama city
Tel
0457872800
rinri@yokohama-cu.ac.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
横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will observe effects on hypoglycemia, glycemic control and psychological aspects between before and 3 months after the introduction of Freestyle Libre 2
Management information
Registered date
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2024 | Year | 08 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062253
