UMIN-CTR Clinical Trial

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
Email	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
Email	k-iwamtsu@tsc.u-tokai.ac.jp

Sponsor
Institute	Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051369