UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032909 |
|---|---|
| Receipt number | R000037524 |
| Scientific Title | Measurement accuracy of flash glucose monitoring in postprandial periods |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2020/04/01 18:21:03 |
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Basic information
Public title
Measurement accuracy of flash glucose monitoring in postprandial periods
Acronym
Measurement accuracy of FGM in postprandial periods
Scientific Title
Measurement accuracy of flash glucose monitoring in postprandial periods
Scientific Title:Acronym
Measurement accuracy of FGM in postprandial periods
Region
| Japan |
Condition
Condition
Japanese adults with type 2
diabetes or impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the accuracy of flash glucose monitoring in postprandial periods
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the difference among glucose levels obtained by FGM, capillary blood glucose, and plasma glucose
Key secondary outcomes
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
individuals with type 2 diabetes or impaired glucose tolerance
Key exclusion criteria
individuals with atopic dermatitis
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oka Rie |
Organization
Kanazawa University Hospital
Division name
Endocrinology and Diabetes
Zip code
Address
13-1 Takara-machi Kanazawa
TEL
076-265-2264
ririoka@goo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takamiya Yukiko |
Organization
Cardiovascular and Internal medicine
Division name
Endocrinology and Diabetes
Zip code
Address
13-1 Takara-machi Kanazawa
TEL
0762652259
Homepage URL
dm2ken@yahoo.co.jp
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
kanazawa University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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 | 06 | Month | 07 | 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 | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
not particular
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037524
