A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure
September 19, 2025 updated by: Narayan (Guru) G. Kowlgi, Mayo Clinic
Non-invasive Measurement of Blood Glucose, Blood Pressure and Extrapolation of QRS Complex Using a Wrist Wearable Photoplethysmography Sensor
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic Minnesota
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Hospitalized Diabetic Group
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.
|
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.
|
|
Experimental: Electrophysiologic (EP) Group
Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline
|
|
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).
|
Baseline
|
|
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.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Narayan Guru G. Kowlgi, MBBS, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 31, 2023
Primary Completion (Actual)
April 30, 2024
Study Completion (Actual)
July 31, 2024
Study Registration Dates
First Submitted
June 6, 2023
First Submitted That Met QC Criteria
June 6, 2023
First Posted (Actual)
June 15, 2023
Study Record Updates
Last Update Posted (Estimated)
October 8, 2025
Last Update Submitted That Met QC Criteria
September 19, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-010799
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.