UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054275 |
|---|---|
| Receipt number | R000061782 |
| Scientific Title | Observational Study of the Relationship between the Use of Real-time Continuous Glucose Monitoring and the Glycemic Control in Patients with Diabetes in Japan |
| Date of disclosure of the study information | 2024/05/02 |
| Last modified on | 2024/10/28 07:50:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Observational Study of the Relationship between the Use of Real-time Continuous Glucose Monitoring and the Glycemic Control in Patients with Diabetes in Japan
Acronym
REALJ study
Scientific Title
Observational Study of the Relationship between the Use of Real-time Continuous Glucose Monitoring and the Glycemic Control in Patients with Diabetes in Japan
Scientific Title:Acronym
REALJ study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the relationship between use of CGM and blood glucose control
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c from baseline to 26 weeks after use of Dexcom G6
Change in TIR (pre, 0week, 26week)
Change in TBR (pre, 0week, 26week)
Change in TAR (pre, 0week, 26week)
Change in glycemia risk index (GRI)(pre, 0week, 26week)
Average glucose levels(pre, 0week, 26week)
Change in glucose management indicator (GMI) (pre, 0week, 26week)
Change in CV(pre, 0week, 26week)
Change in CGM active time(pre, 0week, 26week)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Use of Dexcom G6 26 weeks or above
18 years old or above
HbA1c 7.5% or above
Key exclusion criteria
A history of real-time CGM use within 12 weeks of Dexcom G6 use
pregnancy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Toyoda |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine,
Zip code
259-1193
Address
143, Shimokasuya, Isehara, Kanagawa, JAPAN
TEL
0463-93-1121
m-toyoda@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masao |
| Middle name | |
| Last name | Toyoda |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine,
Zip code
259-1193
Address
143, Shimokasuya, Isehara, Kanagawa, JAPAN
TEL
0463-93-1121
Homepage URL
m-toyoda@tokai.ac.jp
Sponsor or person
Institute
Tokai University
Institute
Department
Personal name
Funding Source
Organization
Dexcom Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
USA
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokai University School of Medicine
Address
143, Shimokasuya, Isehara, Kanagawa, JAPAN
Tel
0463-93-1121
tokai-rec@tokai.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
| 2024 | Year | 05 | Month | 02 | 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 | 04 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multi-center, retrospective, observational study, and subjects will continue the routine clinical practice.
Management information
Registered date
| 2024 | Year | 04 | Month | 27 | Day |
Last modified on
| 2024 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061782
