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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037523
Receipt No. R000042782
Scientific Title Comparison of personal and professional continuous glucose monitoring calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria
Date of disclosure of the study information 2019/07/29
Last modified on 2019/07/29

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Basic information
Public title Comparison of personal and professional continuous glucose monitoring calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria
Acronym ISOperpro study
Scientific Title Comparison of personal and professional continuous glucose monitoring calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria
Scientific Title:Acronym ISOperpro study
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 accuracy of personal and professional continuous glucose monitoring (CGM) calibrated using a point-of-care device based on or not based on ISO 15197:2013 criteria (ISO) by evaluating sensor glucose variability in pre and post of blood glucose levels used to calibrate (BGc)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison between 330 sets of CaI (original index) calibrated by devices based on ISO and 330 sets of that calibrated by devices not based on ISO in both CGM.
Key secondary outcomes Comparison between 330 sets of absolute relative difference (ARD) calibrated by devices based on ISO and 330 sets of that calibrated by devices not based on ISO, in both CGM.
Comparison of 90 sets of CaI or ARD between preprandial and postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM.
Relationship between CaI and ARD in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM.
Prediction ability or cutoff values for ARD > 10% in CaI in preprandial or postprandial glucose levels on days 2 or 5 calibrated by devices based on ISO or not based on ISO, in both CGM.

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 We measure preprandial and bedtime glucose levels on days 2-5 of wearing the CGM devices, in addition, we also measure postprandial glucose levels on days 2 and 5. ISO, next, not ISO group: days 2 and 3: a device based on ISO, days 4 and 5: a device not based on ISO.
Interventions/Control_2 We measure preprandial and bedtime glucose levels on days 2-5 of wearing the CGM devices, in addition, we also measure postprandial glucose levels on days 2 and 5. not ISO, next, 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 2-5 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 30

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
2019 Year 07 Month 29 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 05 Day
Date of IRB
2019 Year 03 Month 19 Day
Anticipated trial start date
2019 Year 03 Month 19 Day
Last follow-up date
2019 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
2019 Year 07 Month 29 Day
Last modified on
2019 Year 07 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042782

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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