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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: LIFELEAF Smartwatch

• Registration Number: NCT05904769
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-05-31
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Primary Completion: 2024-04-30
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-20
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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.

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Exclusion Criteria

• Patients unable to provide informed consent.
• Patients without arms as these are needed to wear the wrist-based sensor.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Electrophysiologic (EP) Group	LIFELEAF Smartwatch	Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.
Hospitalized Diabetic Group	LIFELEAF Smartwatch	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.

Primary Outcome Measures

Name	Time	Method
Systolic blood pressure	Baseline	Measured in millimeters of mercury (mmHg)
Diastolic blood pressure	Baseline	Measured in millimeters of mercury (mmHg)
Blood glucose level	Baseline	Measured in milligrams per deciliter (mg/dL)

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States