Not provided
Not provided
Not provided
Not provided
Not provided
Lack of staffing support
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Electrophysiologic (EP) Group | Experimental | Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Narayan Guru G. Kowlgi, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Minnesota | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support. | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
Adverse events were collected from the time of informed consent through the end of study completion, approximately 24 hours.
Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
The study was terminated early due to lack of staffing support.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Guru Kowlgi M.B.B.S., M.S. | Mayo Clinic | 507-422-0549 | Kowlgi.NarayanGurukripa@mayo.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 10, 2022 | May 23, 2025 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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. |
|
|
| Primary | 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). | Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support. | Posted | Mean | Standard Deviation | mmHg | Baseline |
|
|
|
| Primary | 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. | 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. | Posted | Baseline |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 87 | 0 | 87 | 0 | 87 |
Not provided
Not provided
Not provided