Non-invasive Measurement with LIFELEAF Smartwatch for Diabetes

Overseen By Heart Rhythm Services Research Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Insulin

Disqualifiers: No arms, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new smartwatch called the LIFELEAF to evaluate its accuracy in measuring blood sugar, blood pressure, and heart activity compared to standard methods. The goal is to determine if this non-invasive watch provides reliable health readings for individuals with diabetes or those undergoing heart procedures. This trial suits diabetic patients who check their blood sugar four times daily or individuals having heart-related medical procedures. As an unphased trial, it offers participants the chance to contribute to innovative technology that could simplify health monitoring.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual medications, especially since the trial involves monitoring with a smartwatch.

What prior data suggests that the LIFELEAF Smartwatch is safe for measuring blood glucose, blood pressure, and ECG?

Research shows that the LIFELEAF Smartwatch has been tested and performs well in tracking blood sugar and blood pressure. Studies found that the smartwatch had only a 2% chance of providing an incorrect glucose reading, comparable to traditional needle-based methods. This indicates that the readings were mostly accurate, with few significant errors.

However, the FDA has not approved smartwatches, including LIFELEAF, for measuring blood sugar. This lack of approval does not imply they are unsafe, but the agency has not officially endorsed them for this purpose.

Overall, the smartwatch demonstrated good accuracy in tests, but understanding its current limitations is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the LIFELEAF Smartwatch because it offers a non-invasive way to monitor blood sugar levels, unlike traditional methods that require frequent finger pricks. This smartwatch could make managing diabetes more comfortable and convenient, especially for hospitalized patients who need regular monitoring. By continuously tracking glucose levels without the need for needles, it has the potential to improve patients' quality of life and provide real-time data for better treatment decisions.

What evidence suggests that the LIFELEAF Smartwatch is effective for measuring diabetes-related metrics?

Research has shown that the LIFELEAF Smartwatch holds promise for measuring blood sugar and blood pressure without needles or cuffs. In this trial, participants in the Hospitalized Diabetic Group will wear the LIFELEAF Smartwatch during their hospital stay, while those in the Electrophysiologic (EP) Group will wear it during their procedure. Studies found its blood sugar readings closely match those from standard devices, with a difference of about 10.8% compared to regular blood glucose meters and 8.5% compared to the Dexcom G6. The smartwatch also maintains a low error rate of 2%, indicating its measurements align well with traditional methods. These findings suggest that the LIFELEAF Smartwatch could reliably monitor important health indicators. ^{2 3 6 7 8}

Who Is on the Research Team?

Narayan Guru G. Kowlgi, MBBS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for diabetic patients who regularly check their blood sugar four times a day and monitor heart rate and blood pressure routinely. It's also for those getting catheter ablation for atrial fibrillation. People not meeting these specific conditions cannot participate.

Inclusion Criteria

I am diabetic, use insulin, and check my blood sugar 4 times a day.

Patients undergoing continuous monitoring for heart rate and blood pressure as part of their routine care

I am having a procedure to correct irregular heartbeats.

Exclusion Criteria

I am able to understand and agree to the study's procedures and risks.

I have arms to wear a wrist-based sensor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Hospital Stay

Hospitalized diabetic subjects wear the LIFELEAF Smartwatch for the duration of their hospital stay

Varies based on hospital stay

Continuous monitoring during hospital stay

EP Procedure

Subjects undergoing an electrophysiologic procedure wear the LIFELEAF Smartwatch for the duration of the procedure

Duration of the procedure

Continuous monitoring during procedure

Follow-up

Participants are monitored for safety and effectiveness after the procedure or hospital stay

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LIFELEAF Smartwatch

Trial Overview The study tests the LIFELEAF Smartwatch's ability to measure blood glucose, blood pressure, and ECG readings against standard medical devices used in healthcare settings.

How Is the Trial Designed?

Group I: Hospitalized Diabetic Group Experimental Treatment 1 Intervention

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.

Group II: Electrophysiologic (EP) Group Experimental Treatment 1 Intervention

Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A 12-week study involving 90 participants with type 2 diabetes found that both supervised exercise and technology-based programs (mobile app and smartwatch) led to similar improvements in glycemic control, measured by HbA1c levels.

Approximately 46% of participants in the supervised group and 43% in the technology groups achieved a clinically meaningful reduction in HbA1c, indicating that technology can be an effective alternative for diabetes management when supervised programs are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based and supervised exercise interventions for individuals with type 2 diabetes: Randomized controlled trial. Timurtas, E., Inceer, M., Mayo, N., et al.[2022]

The Diabesdagboga smartphone app and Diani web portal allow for comprehensive tracking of diabetes-related data, including blood sugar levels, carbohydrate intake, insulin doses, and physical activity, enhancing patient engagement and data analysis.

A case report of a patient using this system for nearly two years showed a significant improvement in metabolic control, with an 18.6 mmol/mol decrease in HbA1c, indicating better long-term blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. Brož, J., Holubová, A., Mužík, J., et al.[2022]

Citations

1. medicaleconomics.com medicaleconomics.com/view/lifeplus-clinically-validates-first-non-invasive-wearable-for-glucose-and-blood-pressure-monitoring

LifePlus clinically validates first non-invasive wearable for ... In clinical trials, LifeLeaf demonstrated a mean absolute relative difference of 10.8% versus traditional blood glucose meters and 8.5% against ...

2. mpo-mag.com mpo-mag.com/breaking-news/clinical-validation-established-for-lifeplus-glucose-and-cuffless-bp-monitoring-device/

Clinical Validation Established for LifePlus' Glucose and ... In head-to-head studies, LifeLeaf achieved a 10.8% MARD against BGM references1 and 8.5% MARD against Dexcom G62 for a target dynamic range of ...

3. lifeplus.ai lifeplus.ai/

LifePlus: Home World's first non-invasive device and platform that measures key health markers, including blood glucose and blood pressure.

4. trial.medpath.com trial.medpath.com/news/09cdcece021e9419/lifeplus-achieves-clinical-validation-for-revolutionary-non-invasive-glucose-and-blood-pressure-monitoring-device

LifePlus Achieves Clinical Validation for Revolutionary Non ... The device achieved impressive accuracy with 10.8% MARD against blood glucose meters and 8.5% MARD against Dexcom G6, while demonstrating blood ...

5. finance.yahoo.com finance.yahoo.com/news/lifeplus-establishes-global-clinical-validation-160600209.html

LifePlus Establishes Global Clinical Validation for First-of- ... LifeLeaf attained a low 2% outlier rate1 in blinded continuous glucose monitoring studies, comparable with invasive alternatives and ...

6. fda.gov fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

Do Not Use Smartwatches or Smart Rings to Measure ... Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate ...

7. lifeplus.ai lifeplus.ai/wp-content/uploads/2025/06/LifeLeaf-gadgetsandwearables-2018-05-17-lifeleaf-2025-06-19-18_30_35.pdf

View PDF - LifePlus This includes heart rate, blood pressure, respiration rate and oxygen saturation. Non-invasive glucose monitoring is considered to be the holy ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1110016824000231

Wearable devices for glucose monitoring: A review of state- ... This paper presents a comprehensive summary of the latest glucose monitoring technologies, including invasive, minimally invasive, and non-invasive methods.