UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042136
Receipt No. R000048066
Scientific Title Simple MAGE
Date of disclosure of the study information 2020/10/16
Last modified on 2020/10/16

* 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 Simple MAGE
Acronym Simple MAGE
Scientific Title Simple MAGE
Scientific Title:Acronym Simple MAGE
Region
Japan

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

Objectives
Narrative objectives1 To propose a metric which is comparable to 24-h MAGE (Simple MAGE) where synchronize automatic calculation in plural patients can be performed using a software which can be used by anyone like Microsoft Excel.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between predicted MAGE and SD
Key secondary outcomes (delta - mean of delta)-square for MAGE derived from SD and simple MAGE

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 Patients with type 2 diabetes whose 24-h glucose levels were measured continuously using CGM.
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Soichi
Middle name
Last name Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code 484-8511
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Email souichi19811225@yahoo.co.jp

Public contact
Name of contact person
1st name Soichi
Middle name
Last name Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code 484-8511
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
TEL 0568-62-8111
Homepage URL
Email souichi19811225@yahoo.co.jp

Sponsor
Institute Inuyama Chuo General Hospital
Institute
Department

Funding Source
Organization Inuyama Chuo General Hospital
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 Inuyama Chuo General Hospital
Address 6, Futagozuka, Goromaru, Inuyama-city, Aichi, Japan.
Tel 0568-62-8111
Email souichi19811225@yahoo.co.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
2020 Year 10 Month 16 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
2020 Year 07 Month 20 Day
Date of IRB
2020 Year 10 Month 15 Day
Anticipated trial start date
2020 Year 10 Month 16 Day
Last follow-up date
2020 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 cross-sectional study. We investigate 24-h glucose levels (00:00-24:00 on day 2) measured continuously using continuous glucose monitor (CGM: iPro2) in 100 patients with type 2 diabetes. Based on the reports where the values of MAGE were 2.4 times of that of SD, MAGE derived from SD and simple MAGE (both are abbreviated as predicted MAGE) are proposed.
Based on the way of thinking unbiased dispersion, deviations of differences between MAGE and predicted MAGE (delta = MAGE - predicted MAGE) from mean are defined as (delta - mean of delta)-square.

Management information
Registered date
2020 Year 10 Month 16 Day
Last modified on
2020 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048066

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.