UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of new index to evaluate accuracy of continuous glucose monitoring
Title of the study (Brief title)	new index to evaluate accuracy of continuous glucose monitoring
Region	Japan

Condition
Condition	Type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the formula which can evaluate the accuracy of CGM more accurately than MARD.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparing the correlation between ARD and SMBG values with that between square root index (SRI) and SMBG values.
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	The CGM (FreeStyle Libre Pro) values and SMBG values which were measured on the same time in the 3 studies in which CGM (FreeStyle Libre Pro) were used. The total 1440 CGM values and 1440 SMBG values
Key exclusion criteria	Judged to be unsuitable for participation for medical reasons
Target sample size	1440

Research contact person
Name of lead principal investigator	Soichi Takeishi
Organization	General Inuyama Chuo Hospital
Division name	Diabetes
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Email	souichi19811225@yahoo.co.jp

Public contact
Name of contact person	Soichi Takeishi
Organization	General Inuyama Chuo Hospital
Division name	Diabetes
Address	6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL	0568-62-8111
Homepage URL
Email	souichi19811225@yahoo.co.jp

Sponsor
Institute	General Inuyama Chuo Hospital
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 29 Day
Anticipated trial start date	2018 Year 01 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	This is a cross-sectional study. We analysed the CGM (FreeStyle Libre Pro) values and SMBG values which were measured on the same time in the 3 studies in which CGM (FreeStyle Libre Pro) were used. The total 1440 CGM values and 1440 SMBG values were analysed. We compared the correlation between ARD and SMBG values with that between SRI and SMBG values.

Management information
Registered date	2018 Year 01 Month 13 Day
Last modified on	2018 Year 05 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035160