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Clinical Trials/NCT05904769
NCT05904769
Terminated
Not Applicable

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

Mayo Clinic1 site in 1 country87 target enrollmentMay 31, 2023
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Mayo Clinic
Enrollment
87
Locations
1
Primary Endpoint
Systolic Blood Pressure
Status
Terminated
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 31, 2023
End Date
July 31, 2024
Last Updated
6 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Narayan (Guru) G. Kowlgi

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Systolic Blood Pressure

Time Frame: Baseline

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).

Diastolic Blood Pressure

Time Frame: Baseline

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).

Blood Glucose Level

Time Frame: Baseline

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.

Study Sites (1)

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