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NCT05904769 Clinical Trial

A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure

Diabetes Clinical Trial

Official title:
Non-invasive Measurement of Blood Glucose, Blood Pressure and Extrapolation of QRS Complex Using a Wrist Wearable Photoplethysmography Sensor

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05904769
Other study ID # 22-010799
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 31, 2023
Est. completion date July 31, 2024

Study information
Verified date June 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to compare blood glucose, blood pressure and electrocardiogram (ECG) readings on the LIFELEAF Smartwatch compared to standard methods of measurement.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 87
Est. completion date July 31, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diabetic patients on insulin undergoing four times daily blood sugar checks as part of standard of care. - Patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care. - Patients undergoing catheter ablation for atrial fibrillation. Exclusion Criteria: - Patients unable to provide informed consent. - Patients without arms as these are needed to wear the wrist-based sensor.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• LIFELEAF Smartwatch
Noninvasive wearable smartwatch/monitor that utilizes photoplethysmography (PPG) which is a set of measurements acquired from the light flashed from the back of the watch and measuring the intensity of the reflected light from the blood in the blood vessels just below the skin at the wrist. Provides a non-invasive method for measuring blood glucose as well as alternative method for measuring blood pressure, heart rate and rhythm, etc.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Systolic blood pressure Measured in millimeters of mercury (mmHg) Baseline
Primary Diastolic blood pressure Measured in millimeters of mercury (mmHg) Baseline
Primary Blood glucose level Measured in milligrams per deciliter (mg/dL) Baseline
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