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

Mayo Clinic

Status: Terminated

Conditions: Diabetes

Treatments: Device: LIFELEAF Smartwatch

Study type: Interventional

Funder types: Other

Identifiers

NCT05904769

22-010799

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 2 patient groups

Hospitalized Diabetic Group

Experimental group

Description:

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.

Treatment:

Device: LIFELEAF Smartwatch

Electrophysiologic (EP) Group

Experimental group

Description:

Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.

Treatment:

Device: LIFELEAF Smartwatch