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

NCT05904769 | Terminated Results FDA Device

• 1 other identifier: 22-010799
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Outcome Measures

Primary Outcomes (3)

• Systolic Blood Pressure

  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).

  Baseline

• Diastolic Blood Pressure

  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).

  Baseline

• Blood Glucose Level

  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.

  Baseline

Study Arms (2)

Hospitalized Diabetic Group

EXPERIMENTAL

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

Electrophysiologic (EP) Group

EXPERIMENTAL

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

Device: LIFELEAF Smartwatch

Interventions

LIFELEAF Smartwatch DEVICE

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.

Electrophysiologic (EP) Group; Hospitalized Diabetic Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

The study was terminated early due to lack of staffing support.

Results Point of Contact

• Title: Guru Kowlgi M.B.B.S., M.S.
• Organization: Mayo Clinic

Kowlgi.NarayanGurukripa@mayo.edu

507-422-0549

Study Officials

• Narayan Guru G. Kowlgi, MBBS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 15, 2023
• Study Start: May 31, 2023
• Primary Completion: April 30, 2024
• Study Completion: July 31, 2024
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)