UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000046608
Receipt number R000053168
Scientific Title Accuracy verification study of a non-invasive blood glucose meter
Date of disclosure of the study information 2022/01/12
Last modified on 2022/01/12 12:03:24

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Basic information

Public title

Accuracy verification study of a non-invasive blood glucose meter

Acronym

Accuracy verification study of a non-invasive blood glucose meter

Scientific Title

Accuracy verification study of a non-invasive blood glucose meter

Scientific Title:Acronym

Accuracy verification study of a non-invasive blood glucose meter

Region

Japan


Condition

Condition

healthy person

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the measurement accuracy of the non-invasive blood glucose meter under development

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To compare blood glucose levels from a non-invasive blood glucose meter being developed in healthy volunteers with those from an invasive blood glucose meter and an outsourced test, and to verify the accuracy of these measurements.

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

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Measuring blood glucose levels with non-invasive blood glucose meters, invasive blood glucose meters, and outsourced testing

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

(1) Adults aged 20 years or older
(2) People who have given written consent for participation in this study.

Key exclusion criteria

1) People who have been diagnosed as diabetic
(2) People who cannot handle their own blood glucose meter
(3) Others who are judged to be inappropriate for the program.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Asao

Organization

Gunma University Hospital

Division name

Innovative Medical Center

Zip code

371-8511

Address

3-39-15, Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8222

Email

asao@gunma-u.ac.jp


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Asao

Organization

Gunma University Hospital

Division name

Innovative Medical Center

Zip code

371-8511

Address

3-39-15, Showa-machi, Maebashi, Gunma, Japan

TEL

027-220-8222

Homepage URL


Email

asao@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

LOOK TEC 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

Gunma Institutional Review Board

Address

3-39-15, Showa-machi, Maebashi, Gunma, Japan

Tel

027-220-7111

Email

ciru_hitotaisho-irb@ml.gunma-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

2022 Year 01 Month 12 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

Preinitiation

Date of protocol fixation

2020 Year 02 Month 05 Day

Date of IRB

2020 Year 02 Month 27 Day

Anticipated trial start date

2022 Year 02 Month 01 Day

Last follow-up date

2023 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 01 Month 12 Day

Last modified on

2022 Year 01 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053168


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name