UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004274
Receipt number R000005126
Scientific Title Evaluation of minimally invasive monitoring system for postprandial hyperglycemia
Date of disclosure of the study information 2010/09/29
Last modified on 2012/03/29 08:12:25

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Basic information

Public title

Evaluation of minimally invasive monitoring system for postprandial hyperglycemia

Acronym

Evaluation of minimally invasive monitoring system for postprandial hyperglycemia

Scientific Title

Evaluation of minimally invasive monitoring system for postprandial hyperglycemia

Scientific Title:Acronym

Evaluation of minimally 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 minimally 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

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Correlation between minimally invasive monitoring sysmtem and plasma glucose at OGTT

Key secondary outcomes



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

minimally invasive monitoring of glucose

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


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 Hideaki Kaneto

Organization

Osaka University School of Medicine

Division name

Department of Endocrinology and Metabolism

Zip code


Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Osaka University School of Medicine

Division name

Department of Endocrinology and Metabolism

Zip code


Address

2-2, Yamadaoka, Suita, Osaka, Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Osaka University School of Medicine

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


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

2010 Year 09 Month 29 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

2010 Year 09 Month 20 Day

Date of IRB


Anticipated trial start date

2010 Year 10 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



Management information

Registered date

2010 Year 09 Month 27 Day

Last modified on

2012 Year 03 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005126


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name