UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026024
Receipt number R000028935
Scientific Title A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~
Date of disclosure of the study information 2017/02/07
Last modified on 2019/08/11 14:17:19

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Basic information

Public title

A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~

Acronym

A clinical trials of non-invasive blood glucose monitoring apparatus

Scientific Title

A clinical trials of non-invasive blood glucose monitoring apparatus ~ in use of improved measuring technique ~

Scientific Title:Acronym

A clinical trials of non-invasive blood glucose monitoring apparatus

Region

Japan


Condition

Condition

adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

An examination of accuracy of the non-invasive blood glucose monitoring apparatus,which is under development.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

An assessment of blood glucose levels calculated by the wavelength apparatus.

Key secondary outcomes

An assessment of fluctuation in concentrations of lipid, electrolytes, hemoglobin, and protein, in glucose and diet tolerance tests.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

We will perform 75g oral glucose tolerance tests 3 times and diet loading tests twice on each subject, and take blood samples of 0'30'60'90'120'180 minutes after glucose and diet loading. At the same time of getting blood sampling, we will perform optical measurements on their fingertips, which will be also recorded every 4 or 5 minute, about 100 times a day. Blood glucose levels calculated by the optical measurements are compared with correct blood glucose levels measured with biochemical analyzer. The loading tests will be performed once a week for 5 weeks. Blood collection amount of one day can be about 40-45 mL.

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

1) Regular employee of SEIKO EPSON corporation.
2) A person who is judged for entering this research in safety by a participating doctor.

Key exclusion criteria

1) less than Hb (hemoglobin) 13.0 g/dL
2) under taking anticoagulant medicine.
3) A person who is judged for having risk in taking 75g glucose by a participating doctor.

Target sample size

3


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsuhisa Komatsu

Organization

Shinshu University School of Medicine

Division name

Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine

Zip code


Address

3-1-1, Asahi Matsumoto-shi, Nagano

TEL

81-263-37-2686

Email

mitsuk@shinshu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ako Oiwa

Organization

Shinshu University School of Medicine

Division name

Division of Diabetes, Endocrinology and Metabolism, Department of Internal Medicine

Zip code


Address

3-1-1, Asahi Matsumoto-shi, Nagano

TEL

81-263-37-2686

Homepage URL


Email

akooiwa@shinshu-u.ac.jp


Sponsor or person

Institute

SEIKO EPSON corporation

Institute

Department

Personal name



Funding Source

Organization

SEIKO EPSON 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

2017 Year 02 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

20

Results

Blood glucose measurement using a non-invasive blood glucose apparatus, which is being developed by Seiko Epson, is still inadequate in terms of accuracy, and it was judged that clinical application of this device was difficult.

Results date posted

2019 Year 08 Month 11 Day

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

No longer recruiting

Date of protocol fixation

2017 Year 01 Month 23 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 23 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

2017 Year 02 Month 07 Day

Last modified on

2019 Year 08 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028935


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name