UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044889 |
|---|---|
| Receipt number | R000051270 |
| Scientific Title | Which determines isCGM sensor accuracy, patient or sensor itself? |
| Date of disclosure of the study information | 2021/07/17 |
| Last modified on | 2022/11/18 09:21:46 |
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Basic information
Public title
Which determines isCGM sensor accuracy, patient or sensor itself?
Acronym
Which determines isCGM sensor accuracy, patient or sensor itself?
Scientific Title
Which determines isCGM sensor accuracy, patient or sensor itself?
Scientific Title:Acronym
Which determines isCGM sensor accuracy, patient or sensor itself?
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study regarding inter-individual variability of sensor accuracy between patients or between individual sensors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between sensors in all patients and distribution of MARD
Key secondary outcomes
Correlation between sensors and distribution of MARD in each patient
Correlation between patients and distribution of MARD
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
Twenty outpatients with type 2 diabetes
Key exclusion criteria
Sensors where mean absolute relative difference (MARD) could not be evaluated more than 9 times
judged to be unsuitable for participation for medical reasons
Target sample size
20
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, 484-8511, 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, 484-8511, 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, 484-8511, 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
| 2021 | Year | 07 | Month | 17 | 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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Twenty outpatients with type 2 diabetes wear an isCGM (FreeStyle Libre) over 12 weeks using 6 sensors. Self-Monitoring of Blood Glucose (SMBG) is performed once a day before breakfast using glucometers that were compliant with ISO15197:2013.
Management information
Registered date
| 2021 | Year | 07 | Month | 17 | 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=R000051270
