UMIN-ICDS Clinical Trial

Public title

Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices

Acronym

Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices

Scientific Title

Research on Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices

Scientific Title:Acronym

Accuracy Verification and Improvement of Wristwatch-type Wearable IoT Devices

Region

Japan

Condition

Patients who, for any reason, measure any vital data with a pulse oximeter, blood pressure monitor, heart rate monitor, respiratory rate monitor, thermometer, or bladder thermometer.

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Wrist-worn wearable IoT (Internet of things) devices are intended to provide a simple method of measuring vital signs and other data in daily life and are expected to be used in the stage between health and disease, before a patient is hospitalized for close monitoring. The objectives of this study are (1) to confirm the accuracy of the vital signs obtained by the wristwatch wearable IoT devices by comparing the vital sign data measured by the medical device with the vital sign data measured by the wristwatch wearable IoT device (the validity of the current product), and (2) to improve the accuracy of vital sign data obtained by the wristwatch wearable IoT device by having AI learn the vital sign data measured by the medical device.

Basic objectives2

Others

Basic objectives -Others

Verification and improvement of device functions

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

To compare age, gender, and vital data collected by a wristwatch wearable IoT device with transcutaneous arterial blood oxygen saturation, blood pressure, heart rate, respiratory rate, skin temperature, and bladder temperature measured by a medical device.

Key secondary outcomes

Training AI with Information from Transcutaneous Arterial Oxygen Saturation, Blood Pressure, Heart Rate, Respiration Rate, Skin Temperature, and Bladder Temperature Measurements in Medical Devices

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients undergoing measurement of any vital data including pulse oximetry, blood pressure, heart rate monitoring, respiration rate monitoring, body temperature, and bladder temperature using pulse oximeters, blood pressure monitors, heart rate monitors, respiration rate monitors, thermometers, and bladder thermometers for various reasons at medical facilities such as Fujii Cardiovascular Internal Medicine and Prefectural Hiroshima Hospital.

Patients who have received explanations and have provided their informed consent.

Key exclusion criteria

Patients for whom obtaining consent through written explanation is challenging.

Patients with unstable conditions.

Patients deemed inappropriate by their attending physician.

Target sample size

200

Name of lead principal investigator

1st name	Yukihito
Middle name
Last name	Higashi

Organization

Hiroshima University Hospital

Division name

Division of Regeneration and Medicine,

Zip code

734-8551

Address

1-2-3 Kasumi, Minami-ku, Hiroshima

TEL

082-257-5831

Email

yhigashi@hiroshima-u.ac.jp

Name of contact person

1st name	Tatsuya
Middle name
Last name	Maruhashi

Organization

Research Institute for Radiation Biology and Medicine, Hiroshima University

Division name

Department of Regenerative Medicine

Zip code

734-8553

Address

1-2-3 Kasumi, Minami-ku

TEL

082-257-5831

Homepage URL

Email

maru0512@hiroshima-u.ac.jp

Institute

Hiroshima University Hospital

Institute

Department

Personal name

Organization

adodice

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethical Committee for Epidemiology of Hiroshima University

Address

1-2-3, Minami-ku, Hiroshima

Tel

082-257-5555

Email

iryo-sinsa@office.hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2022

Year

11

Month

24

Day

Date of IRB

2023

Year

02

Month

06

Day

Anticipated trial start date

2023

Year

02

Month

06

Day

Last follow-up date

2027

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

no

Registered date

2023

Year

08

Month

10

Day

Last modified on

2023

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059197