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

Not Applicable

Terminated

• Conditions: Diabetes

• 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

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
• Disposition First Submitted: 2025-04-30
• Results First Submitted: 2025-07-23
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-19
• Last Update Submitted: 2025-09-19
• Results First Posted: 2025-10-08
• Disposition First Posted: 2025-10-08
• Last Update Posted: 2025-10-08

Recruitment & Eligibility

• Status: TERMINATED
• 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, 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	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	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	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.

Trial Locations

Locations (1)

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