UMIN-CTR Clinical Trial

Basic information
Public title	Empirical study of the relationship between pulse wave signals and blood glucose
Acronym	Empirical study of the relationship between pulse wave signals and blood glucose
Scientific Title	Empirical study of the relationship between pulse wave signals and blood glucose
Scientific Title:Acronym	Empirical study of the relationship between pulse wave signals and blood glucose
Region	Japan

Condition
Condition	impaired glucose tolerance, Prediabetes, Diabetes
Classification by specialty	Medicine in general Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the relationship between blood glucose and pulse wave signals by simultaneously measuring blood glucose and pulse waves, and to measure blood glucose non-invasively using pulse wave signals alone. To clarify the validity of the relationship between blood glucose and pulse wave signals in people of all ages with diabetes and impaired glucose tolerance.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	(1) Relationship between pulse wave signal and venous blood glucose (2) Relationship between pulse wave signal and peripheral blood glucose
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	Diagnosis
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	1) Simultaneous pulse wave signal measurement and venous blood sampling in the laboratory, and blood glucose measurement using a venous blood analyzer and a self monitoring of blood glucose. 2) Measurement of pulse wave signal and self monitoring of blood glucose with peripheral blood in daily life.
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients visiting Asama General Hospital 2) Patients who have given written consent for participation in this study
Key exclusion criteria	1) Patients with metal allergies
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Eita Middle name Last name Nishimori
Organization	Asama General Hospital
Division name	Diabetes Medicine
Zip code	385-8558
Address	1862-1 Iwamurada, Saku, Nagano
TEL	0267-67-2295
Email	westwoods0616@gmail.com

Public contact
Name of contact person	1st name Eita Middle name Last name Nishimori
Organization	Asama General Hospital
Division name	Diabetes Medicine
Zip code	385-8558
Address	1862-1 Iwamurada, Saku, Nagano
TEL	0267-67-2295
Homepage URL
Email	westwoods0616@gmail.com

Sponsor
Institute	Asama General Hospital
Institute
Department

Funding Source
Organization	Asama General Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	SSST Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Asama General Hospital
Address	1862-1 Iwamurada, Saku, Nagano
Tel	0267-67-2295
Email	asama-soumu@city.saku.nagano.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	2021 Year 01 Month 25 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	Enrolling by invitation
Date of protocol fixation	2020 Year 11 Month 18 Day
Date of IRB	2020 Year 11 Month 30 Day
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 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	2021 Year 01 Month 25 Day
Last modified on	2021 Year 01 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049224