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

A study testing LIFELEAF Smartwatch in people with Diabetes, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes
What is being tested?: LIFELEAF Smartwatch
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 87 participants
Where: 1 siteUnited States
Study dates: 31 May 2023to 31 Jul 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic Minnesota
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Conditions: Diabetes
Being tested: LIFELEAF Smartwatch
Medical subject headings: Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LIFELEAF SmartwatchDevice
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.

Study groups in NCT05904769
Study group	Role	What they receive
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. Receives: Device: LIFELEAF Smartwatch
Electrophysiologic (EP) Group	Experimental	Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure. Receives: Device: LIFELEAF Smartwatch

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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).
Measured: 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.
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

31 May 202331 Jul 2024

First posted15 Jun 2023
Study start31 May 2023
Primary completion30 Apr 2024
Study completion31 Jul 2024

Why it stopped: Lack of staffing support

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05904769
Sponsor's protocol ID: 22-010799
Status last verified: Sep 2025
First submitted: 6 Jun 2023
Last updated: 8 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
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Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Diabetes trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Measurement of Blood Glucose, Blood Pressure and Extrapolation of QRS Complex Using a Wrist Wearable Photoplethysmography Sensor
ClinicalTrials.gov ID: NCT05904769
Acronym / sponsor ID: 22-010799
Conditions: Diabetes
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lack of staffing support
Enrolment: 87 participants (actual)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 31 May 2023 (actual)
Primary completion: 30 Apr 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 15 Jun 2023 (actual)
Results: Posted 8 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Health services research
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Hospitalized Diabetic Group	Experimental	Device: LIFELEAF SmartwatchSubjects 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	Device: LIFELEAF SmartwatchSubjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LIFELEAF SmartwatchNoninvasive 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.	Device	Electrophysiologic (EP) Group, Hospitalized Diabetic Group

Primary outcome

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).
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).
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.

Results and safety

Results posted to the registry on 8 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hospitalized Diabetic Group	0	0
Electrophysiologic (EP) Group	87	81

Primary outcome: Systolic Blood Pressure

Time frame: Baseline. Mean (Standard Deviation). Unit: mmHg

Measure	Hospitalized Diabetic Group n = 0	Electrophysiologic (EP) Group n = 81
Value	–	13.08 (17.22)

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

Primary outcome: Diastolic Blood Pressure

Time frame: Baseline. Mean (Standard Deviation). Unit: mmHg

Measure	Hospitalized Diabetic Group n = 0	Electrophysiologic (EP) Group n = 81
Value	–	8.42 (10.56)

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

Primary outcome: Blood Glucose Level

Time frame: Baseline

Population analysed: 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.

Adverse events

Time frame: Adverse events were collected from the time of informed consent through the end of study completion, approximately 24 hours.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hospitalized Diabetic Group	0 of 0	0 of 0	0
Electrophysiologic (EP) Group	0 of 87 (0%)	0 of 87 (0%)	0 of 87

Limitations and caveats (from the sponsor): The study was terminated early due to lack of staffing support.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Diabetes

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Narayan Guru G. Kowlgi, MBBS principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LIFELEAF Smartwatch in people with Diabetes, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Systolic Blood Pressure (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05904769.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.