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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007355
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kobe University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008668

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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