UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045896 |
|---|---|
| Receipt number | R000051369 |
| Scientific Title | Assessment of Time in Range by Daily Blood Glucose Monitor and Continuous Glucose Monitoring |
| Date of disclosure of the study information | 2021/10/28 |
| Last modified on | 2021/10/28 11:23:08 |
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Basic information
Public title
Assessment of Time in Range by Daily Blood Glucose Monitor and Continuous Glucose Monitoring
Acronym
TIR study
Scientific Title
Assessment of Time in Range by Daily Blood Glucose Monitor and Continuous Glucose Monitoring
Scientific Title:Acronym
TIR study
Region
| Japan |
Condition
Condition
Type 1 diabetes, Type 2 diabetees
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of TIR obtained from SMBG and CGM in patients with type 1 and type 2 diabetes, and evaluation of the relationship with HbA1c.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of TIR obtained from SMBG and CGM.
Key secondary outcomes
Comparison of TAR and TBR obtained from SMBG and CGM, and correlation with HbA1c and GA.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 1 diabetes mellitus
Type 2 diabetes mellitus
Receiving insulin therapy and/or GLP-1RA
SMBG more than 20 times per month
Key exclusion criteria
Woman of pregnant or planning to get pregnant
Blinded patient
There are shunts on both left and right arms
Using an implantable medical device such as a pacemaker
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Toyoda |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
m-toyoda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kanori |
| Middle name | |
| Last name | Iwamatsu |
Organization
Department of Internal Medicine, Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
Homepage URL
k-iwamtsu@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
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
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
Tel
0463-93-1121
tokai-rinsho@ml.tokai-u.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
| 2021 | Year | 10 | Month | 28 | 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
43
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
unspecified
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | 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=R000051369
