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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039422
Receipt No. R000044946
Scientific Title Comparison of glycemic variability calculated from personal and professional continuous glucose monitoring data
Date of disclosure of the study information 2020/02/07
Last modified on 2020/02/07

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Basic information
Public title Comparison of glycemic variability calculated from personal and professional continuous glucose monitoring data
Acronym Glycemic variability calculated from personal and professional continuous glucose monitoring data
Scientific Title Comparison of glycemic variability calculated from personal and professional continuous glucose monitoring data
Scientific Title:Acronym Glycemic variability calculated from personal and professional continuous glucose monitoring data
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 glycemic variability calculated from personal and professional continuous glucose monitoring data
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of the following glycemic variability metrics calculated from 24-h SGs between both CGM calibrated by devices based on ISO and calibrated by devices not based on ISO.
Mean absolute glucose (MAG)
Glycemic variability percentage (GVP)
Key secondary outcomes Secondary endpoint
Comparison of the following glycemic variability metrics calculated from 24-h SGs between both CGM calibrated by devices based on ISO and calibrated by devices not based on ISO.
Percentage of time in target range (70~180 mg/dL)
Mean glucose level
Standard deviation (SD)
Coefficient of variation (CV)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Study participants are patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. ISO,not ISO group: days 2 and 3: a device based on ISO, days 4 and 5
Interventions/Control_2 Study participants are patients with type 2 diabetes who wear personal and professional CGM in parallel for 6 days. not ISO,ISO group: days 2 and 3: a device not based on ISO, days 4 and 5: a device based on ISO.
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 who wear personal and professional CGM in parallel for 6 days and whose preprandial and bedtime glucose levels on days 2 to 5 of wearing the CGM devices, and in addition, postprandial glucose levels on days 2 and 5 can be evaluated.
Key exclusion criteria judged to be unsuitable for participation for medical reasons
Target sample size 60

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 self funding
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 02 Month 07 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
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 07 Month 10 Day
Anticipated trial start date
2019 Year 07 Month 10 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

Management information
Registered date
2020 Year 02 Month 07 Day
Last modified on
2020 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044946

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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