UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027488 |
|---|---|
| Receipt number | R000031495 |
| Scientific Title | The observational study about glucose profile using continuous glucose monitoring device in diabetes patients |
| Date of disclosure of the study information | 2017/05/26 |
| Last modified on | 2022/12/22 15:01:01 |
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Basic information
Public title
The observational study about glucose profile using continuous glucose monitoring device in diabetes patients
Acronym
The observational study about glucose profile using continuous glucose monitoring device in diabetes patients
Scientific Title
The observational study about glucose profile using continuous glucose monitoring device in diabetes patients
Scientific Title:Acronym
The observational study about glucose profile using continuous glucose monitoring device in diabetes 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 glucose profile and changes of the consciousness to glucose management in each diabetic patient using continuous glucose monitoring device (The FreeStyle Libre Pro Flash Glucose Monitoring System)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The glucose profile in each patient including the degree of hyperglycemia or hypoglycemia, glycemic variability including mean glucose level, mean amplitude of glycemic excursions (MAGE) and standard deviation (SD)
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Diabetes patients (20 years of age or older) who are decided to perform clinical evaluation of glucose profile using The FreeStyle Libre Pro Flash Glucose Monitoring System
2)The patients who provided written informed consent to join this study
Key exclusion criteria
1)The patients who are considered as inadequate by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Sekine |
Organization
Shiga University of Medical Science
Division name
Department of Medicine, Division of Diabetes and Nephrology
Zip code
520-2192
Address
Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL
077-548-2222
sekine@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Osamu |
| Middle name | |
| Last name | Sekine |
Organization
Shiga University of Medical Science
Division name
Department of Medicine, Division of Diabetes and Nephrology
Zip code
520-2192
Address
Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL
077-548-2222
Homepage URL
sumsdmg@gmail.com
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
Shiga University of Medical Science
Address
Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
Tel
077-548-3576
hqrec@belle.shiga-med.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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 26 | 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
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observe glucose profile using continuous glucose monitoring device in diabetes patients
Management information
Registered date
| 2017 | Year | 05 | Month | 25 | Day |
Last modified on
| 2022 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031495
