UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018962
Receipt number R000021892
Scientific Title A clinical trial of non-invasive blood glucose monitoring apparatus
Date of disclosure of the study information 2015/09/14
Last modified on 2023/03/20 18:00:59

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Basic information

Public title

A clinical trial of non-invasive blood glucose monitoring apparatus

Acronym

A clinical trial of non-invasive blood glucose monitoring apparatus

Scientific Title

A clinical trial of non-invasive blood glucose monitoring apparatus

Scientific Title:Acronym

A clinical trial of non-invasive blood glucose monitoring apparatus

Region

Japan


Condition

Condition

Healthy 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 accuracy evaluation of blood glucose levels derived from wavelength calculations of fingertips, whole blood, and blood plasma measured with the apparatus in a non-invasive manner.

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

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 perform 75g oral glucose tolerance tests on examiners, and take blood samples of 0' 30' 60' 90' 120' 180 minutes after glucose load. At the same time, the optical measurements on their fingertips are recorded in each time. Blood glucose levels calculated by the optical measurements are compared with correct blood glucose levels measured with biochemical analyzer. Whole blood and blood plasma taken in each time are also calculated by the optical measurements.
The 75g oral tolerance tests are performed once a week, for 5 weeks. Blood collection amount of one day can be from 70 to 80 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

Key inclusion criteria

1) Regular employee of SEIKO EPSON corporation.
2) A or B dicision in glucose metabolism on periodical health examination.
3) A or B or C dicision on synthetic judgement on periodical health examination.

Key exclusion criteria

1) Patients with diabetes mellitus.
2) less than Hb (hemoglobin) 13.0 g/dL.
3) considered to be inappropriate by responsible doctors for this research.

Target sample size

3


Research contact person

Name of lead principal investigator

1st name Mitsuhisa
Middle name
Last name Komatsu

Organization

Shinshu University School of Medicine

Division name

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

Zip code

390-8621

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 Ako
Middle name
Last name Oiwa

Organization

Shinshu University School of Medicine

Division name

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

Zip code

390-8621

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

The ethics committee of the Shinshu University School of Medicine

Address

3-1-1 Asahi Matsumoto, Nagano-ken, Japan

Tel

0263-37-2572

Email

mdrinri@shinshu-u.ac.jp


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

2015 Year 09 Month 14 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

3

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

2015 Year 08 Month 04 Day

Date of IRB

2015 Year 08 Month 17 Day

Anticipated trial start date

2015 Year 09 Month 11 Day

Last follow-up date

2015 Year 11 Month 11 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 09 Month 10 Day

Last modified on

2023 Year 03 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021892


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name