UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007355 |
|---|---|
| Receipt number | R000008668 |
| Scientific Title | Evaluation of minimal invasive monitoring system for postprandial hyperglycemia |
| Date of disclosure of the study information | 2012/02/23 |
| Last modified on | 2013/02/24 09:38:01 |
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Basic information
Public title
Evaluation of minimal invasive monitoring system for postprandial hyperglycemia
Acronym
Evaluation of minimal invasive monitoring system for postprandial hyperglycemia
Scientific Title
Evaluation of minimal invasive monitoring system for postprandial hyperglycemia
Scientific Title:Acronym
Evaluation of minimal invasive monitoring system for postprandial hyperglycemia
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the performance of minimal invasive monitoring system, interstitial fluid samples are analyzed at OGTTs for diabetes and pre-diabetic patients. Efficacy of the system is confirmed by the comparison between interstitial fluid and extracted blood samples.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between minimal invasive monitoring system and plasma glucose at OGTT
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
| 19 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who do OGTT as a diagnosis or a treatment
Key exclusion criteria
Patients who have skin diseases on forearm
Pregnant
Patients who require specific therapy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Sakaguchi |
Organization
Kobe University
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
7-5-2, Kusunokicho, chuo-ku, kobe, hyogo, Japan
TEL
078-382-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kobe University
Division name
Division of Diabetes, Metabolism and Endocrinology
Zip code
Address
TEL
078-382-5111
Homepage URL
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Sysmex Corporation
Organization
Division
Category of Funding Organization
Profit organization
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
| 2012 | Year | 02 | Month | 23 | 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
| 2012 | Year | 03 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the performance of minimal invasive monitoring system, interstitial fluid samples are analyzed at OGTTs for diabetes. Efficacy of the system is confirmed by the comparison between interstitial fluid and extracted blood samples.
Management information
Registered date
| 2012 | Year | 02 | Month | 22 | Day |
Last modified on
| 2013 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008668
