Diabetes
Conditions
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.
Interventions
DEVICELIFELEAF 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.
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Pre-assignment details
Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 0 |
| 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. | 87 |
| Total | 87 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 6 |
Baseline characteristics
| Characteristic | Total | Electrophysiologic (EP) Group |
|---|---|---|
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.24 | 62.3 years STANDARD_DEVIATION 10.24 |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 87 participants | 87 participants |
| Sex: Female, Male Female | 27 Participants | 27 Participants |
| Sex: Female, Male Male | 60 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 87 |
| other Total, other adverse events | 0 / 0 | 0 / 87 |
| serious Total, serious adverse events | 0 / 0 | 0 / 87 |
Outcome results
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.
Time frame: 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.
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).
Time frame: Baseline
Population: Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrophysiologic (EP) Group | Diastolic Blood Pressure | 8.42 mmHg | Standard Deviation 10.56 |
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).
Time frame: Baseline
Population: Zero subjects were enrolled in the hospitalized diabetic arm as the study was terminated early due to a lack of staffing support.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Electrophysiologic (EP) Group | Systolic Blood Pressure | 13.08 mmHg | Standard Deviation 17.22 |