UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034125
Receipt No. R000038899
Scientific Title Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography.
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/13

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography.
Acronym Blood sugar estimation using an photoplethysmography.
Scientific Title Study on blood sugar level estimation with the light vital signs sensor using an electric photoplethysmography.
Scientific Title:Acronym Blood sugar estimation using an photoplethysmography.
Region
Japan

Condition
Condition Diabetes Mellitus
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to compare the blood sugar level using the self-blood sugar measuring instrument with the blood sugar level estimated from the pulse wave form using an electric photoplethysmography, and to inspect and verify the algorithm of the measurement.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pulse wave form detected by an electric photoplrthysmography.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Blood sugar level measured by a self-blood sugar measuring instrument.
Interventions/Control_2 The blood sugar level estimated from the pulse wave form detected by an electric photoplethysmography.
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
90 years-old >
Gender Male and Female
Key inclusion criteria Healthy volunteers and the relatively controled patients with diabeted mellitus (HbA1c<8.0% and FBS<200mg/dl).
Key exclusion criteria Subjects having chronic arterial fibrillation, severe arrhythmia, perpheral circulatory failure such as Raynaud's disease, severe deformed nail, and are judged as inappropriate by chief researcher.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keisaku Fujimoto
Organization Shinshu University School of Health Sciences
Division name Department of Clinical Laboratory Sciences
Zip code
Address 3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL +81-263-37-2393
Email keisaku@shinshu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Keisaku Fujimoto
Organization Shinshu University School of Health Sciences
Division name Department of Clinical Laboratory Sciences
Zip code
Address 3-1-1, Asahi, Matsumoto, Naganoken, 390-8621, Japan
TEL +81-263-37-2393
Homepage URL
Email keisaku@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization Murata Manufacturing Co., Ltd.
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
2018 Year 10 Month 01 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
2018 Year 09 Month 04 Day
Date of IRB
Anticipated trial start date
2018 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
2018 Year 09 Month 13 Day
Last modified on
2018 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038899

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.