UMIN-CTR Clinical Trial

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	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	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	Completed
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	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	2019 Year 07 Month 29 Day
Last modified on	2022 Year 11 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042782