UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037523 |
|---|---|
| Receipt number | 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 | 2022/11/18 09:15:36 |
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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
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
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
souichi19811225@yahoo.co.jp
Sponsor or person
Institute
Inuyama Chuo General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042782
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
