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

Mayo Clinic87 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Diabetes

Interventions

LIFELEAF SmartwatchDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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, ECG and blood pressure as part of their routine care. * Patients undergoing invasive and noninvasive electrophysiologic procedures. Exclusion Criteria: * Patients unable to provide informed consent. * Patients without arms as these are needed to wear the wrist-based sensor.

Locations (1)

Mayo Clinic Minnesota

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Systolic Blood Pressure

Difference in measurement of Systolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).

Time frame: Baseline

Diastolic Blood Pressure

Difference in measurement of Diastolic Blood Pressure using the wrist-based PPG sensor versus invasive measurement of blood pressure measured in millimeters of mercury (mmHg).

Time frame: Baseline

Blood Glucose Level

The difference in measurement of blood glucose levels using the wrist-based PPG sensor versus standard blood-based measurement measured in milligrams per deciliter (mg/dL) in subjects who had standard of care blood glucose monitoring done. Only subjects who are hospitalized and diabetic per standard of care receive standard of care blood-based glucose monitoring.

Time frame: Baseline

Data from ClinicalTrials.gov

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