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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033429
Receipt No. R000038120
Scientific Title Comparison of the glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using continuous glucose monitoring
Date of disclosure of the study information 2018/07/18
Last modified on 2018/07/18

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Basic information
Public title Comparison of the glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using continuous glucose monitoring
Acronym The glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using continuous glucose monitoring
Scientific Title Comparison of the glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using continuous glucose monitoring
Scientific Title:Acronym The glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using 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 compare the glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 minutes using continuous glucose monitoring
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following glycemic variability metrics values calculated from the glucose levels measured every 5 vs. 15 (extraction) minutes
Percentage of time in target range (70~180 mg/dL)
Mean absolute glucose (MAG)
Glycemic variability percentage (GVP)
Mean glucose level
Standard deviation (SD)
Coefficient of variation (CV)
Low blood glucose index (LBGI)
High blood glucose index (LBGI)
Key secondary outcomes The formulae which predict glycemic variability metrics values (every 5 minutes) from those (every 15 (extraction) minutes).

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 using continuous glucose monitor (iPro2).
Key exclusion criteria Judged to be unsuitable for participation for medical reasons
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
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
Middle name
Last name Soichi Takeishi
Organization Inuyama Chuo General Hospital
Division name Diabetes
Zip code
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
Address
Tel
Email

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 07 Month 18 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
2018 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 18 Day
Last follow-up date
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 the continuous glucose monitor (iPro2) data of 120 patients with type 2 diabetes whose 24-h glucose levels were measured continiuously. We analyse the continuous glucose monitor data from 00:00 to 24:00 on day 2.

Management information
Registered date
2018 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038120

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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