Trial Outcomes & Findings for A Study of Non-invasive Measurement of Blood Glucose and Blood Pressure (NCT NCT05904769)

Results Overview

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).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

87 participants

Primary outcome timeframe

Baseline

Results posted on

2025-10-08

Participant Flow

Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.

Participant milestones

Participant milestones
Measure	Hospitalized Diabetic Group Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay. LIFELEAF Smartwatch: 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 Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure. LIFELEAF Smartwatch: 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.
Overall Study STARTED	0	87
Overall Study COMPLETED	0	81
Overall Study NOT COMPLETED	0	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Hospitalized Diabetic Group Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay. LIFELEAF Smartwatch: 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 Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure. LIFELEAF Smartwatch: 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.
Overall Study Physician Decision	0	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hospitalized Diabetic Group Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay. LIFELEAF Smartwatch: 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 n=87 Participants Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure. LIFELEAF Smartwatch: 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.	Total n=87 Participants Total of all reporting groups
Age, Continuous	—	62.3 years STANDARD_DEVIATION 10.24 • n=87 Participants	62.3 years STANDARD_DEVIATION 10.24 • n=87 Participants
Sex: Female, Male Female	—	27 Participants n=87 Participants	27 Participants n=87 Participants
Sex: Female, Male Male	—	60 Participants n=87 Participants	60 Participants n=87 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	—	87 participants n=87 Participants	87 participants n=87 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.

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).

Outcome measures

Outcome measures
Measure	Hospitalized Diabetic Group Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay. LIFELEAF Smartwatch: 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 n=81 Participants Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure. LIFELEAF Smartwatch: 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.
Systolic Blood Pressure	—	13.08 mmHg Standard Deviation 17.22

PRIMARY outcome

Timeframe: Baseline

Population: Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.

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).

Outcome measures

Outcome measures
Measure	Hospitalized Diabetic Group Subjects hospitalized and diabetic on insulin, undergoing four times daily blood sugar checks, wore the LIFELEAF Smartwatch for the duration of their hospital stay. LIFELEAF Smartwatch: 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 n=81 Participants Subjects undergoing an EP procedure wore the LIFELEAF Smartwatch for the duration of the procedure. LIFELEAF Smartwatch: 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.
Diastolic Blood Pressure	—	8.42 mmHg Standard Deviation 10.56

PRIMARY outcome

Timeframe: Baseline

Population: 0 subjects enrolled in the hospitalized diabetic arm as study was terminated early (lack of staffing support). Data not collected for this outcome measure in the EP group as it didn't apply to the EP arm. Standard blood-based glucose measurements were only measured on subjects that were diabetic + hospitalized. EP subjects were not hospitalized; due to this standard blood glucose was not monitored in this group therefore a comparison couldn't be made to the PPG sensor blood glucose measurements.

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.

Outcome measures

Outcome data not reported

Adverse Events

Hospitalized Diabetic Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electrophysiologic (EP) Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Guru Kowlgi M.B.B.S., M.S.

Mayo Clinic

Phone: 507-422-0549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place