UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033431 |
|---|---|
| Receipt number | R000038121 |
| Scientific Title | Comparison of the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously |
| Date of disclosure of the study information | 2018/07/18 |
| Last modified on | 2022/11/18 09:14:29 |
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Basic information
Public title
Comparison of the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Acronym
The glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Scientific Title
Comparison of the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Scientific Title:Acronym
The glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Region
| Japan |
Condition
Condition
type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the glycemic variability metrics values calculated using FGM vs. CGM sensor glucose measured simultaneously
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The formulae which predict the following glycemic variability metrics values calculated using CGM sensor glucose (every 5 minutes [iPro2]) from those calculated using FGM sensor glucose (every 15 minutes [FreeStyle Libre Pro]). (if significant association exists)
Percentage of time in target range (70~180 mg/dL)
Mean absolute glucose (MAG)
Glycemic variability percentage (GVP)
Mean glucose level
Standard deviation (SD)
Coefficient of variation (CV)
Low blood glucose index (LBGI)
High blood glucose index (LBGI)
Key secondary outcomes
The association between glycemic variability metrics values (every 5 minutes [iPro2], 15 (extraction) minutes [iPro2], and 15 minutes [FreeStyle Libre Pro]) (except primary endpoint)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
120 patients with type 2 diabetes wear continuous glucose monitor devices (iPro2 and FreeStyle Libre Pro) and 24-h glucose levels were simultaneously measured continiuously. iPro2 is worn on 6 days after FreeStyle Libre Pro is worn. We analyse the continuous glucose monitor data from 00:00 to 24:00 (iPro2: on day 2 and FreeStyle Libre Pro: on day 8 (Same period)).
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
Patients with type 2 diabetes who agree wearing CGMs (iPro2 and FreeStyle Libre Pro) simultaneously
Key exclusion criteria
Judged to be unsuitable for participation for medical reasons
Target sample size
120
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
| 2018 | Year | 07 | Month | 18 | 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
| 2018 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 18 | 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=R000038121
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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