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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Device: LIFELEAF Smartwatch


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hospitalized Diabetic Group<br>Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, will wear the LIFELEAF Smartwatch for the duration of their hospital stay. | Device: LIFELEAF Smartwatch<br>* 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.<br>|
| Experimental: Electrophysiologic (EP) Group<br>Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure. | Device: LIFELEAF Smartwatch<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure | Measured in millimeters of mercury (mmHg) | Baseline | 
| Diastolic blood pressure | Measured in millimeters of mercury (mmHg) | Baseline | 
| Blood glucose level | Measured in milligrams per deciliter (mg/dL) | Baseline |