NCT06717646

Brief Summary

This investigational study is carried out to find out if a smartwatch monitor worn on the wrist that acts like a blood pressure monitor, will be able to replace the traditional blood pressure measurements using the traditional cuff that is wrapped around your arm.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 11, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 5, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

December 5, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

November 18, 2024

Last Update Submit

December 3, 2024

Conditions

Blood Glucose MonitoringBlood Pressure Measurement

Outcome Measures

Primary Outcomes (3)

  • Comparable results to traditional methods

    Perform comparably to the 24-hour ambulatory blood pressure meters and continuous glucose monitors (CGM) to establish hypertension and blood glucose changes

    24 Hours

  • Improve efficiency

    Provide real time feedback to patients and healthcare providers to individualize hypertension / hyperglycemic treatment

    24 Hours

  • Lifestyle Improvement

    Consider patient lifestyle changes and reduce medication burden, especially in the elderly when blood pressure control is optimal.

    24 Hours

Study Arms (2)

Inpatient

Patients warded under National Heart Centre Singapore

Outpatients

Patients scheduled for 24-hour Ambulatory Blood Pressure Monitoring at National Heart Centre Singapore

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients from National Heart Centre Singapore

You may qualify if:

  • Above 21 years of age
  • Sufficient language skills in English, Chinese, Malay or Tamil
  • Provided informed consent

You may not qualify if:

  • Skin sensitivity to adhesives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Heart Centre Singapore

Singapore, 169609, Singapore

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2024

First Posted

December 5, 2024

Study Start

April 11, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

December 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will share

Locations

SG(1)