87 Participants Needed

Non-invasive Measurement with LIFELEAF Smartwatch for Diabetes

HR
Overseen ByHeart Rhythm Services Research Team
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment LIFELEAF Smartwatch for diabetes?

Research shows that wearable devices, like smartwatches, can help people with diabetes by providing continuous glucose monitoring, which helps improve glucose control. For example, a study found that using a similar wearable device improved diabetes management by providing useful information about glucose trends.12345

How does the LIFELEAF Smartwatch treatment for diabetes differ from other treatments?

The LIFELEAF Smartwatch offers a unique, non-invasive way to monitor blood sugar levels using smartwatch data, unlike traditional methods that require blood samples. This approach uses multiple sensors to track glucose trends, providing a convenient and painless alternative for diabetes management.46789

What is the purpose of this trial?

This trial aims to evaluate the LIFELEAF Smartwatch's ability to measure blood glucose, blood pressure, and heart activity. The smartwatch uses sensors to track these health metrics and displays the results on the device. The study focuses on people who need regular monitoring of these health indicators.

Research Team

NG

Narayan Guru G. Kowlgi, MBBS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Hospitalized Diabetic GroupExperimental Treatment1 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) GroupExperimental Treatment1 Intervention
Subjects undergoing an EP procedure will wear he LIFELEAF Smartwatch for the duration of the procedure.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Findings from Research

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.
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.
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]

References

Technology-based and supervised exercise interventions for individuals with type 2 diabetes: Randomized controlled trial. [2022]
2.Czech Republicpubmed.ncbi.nlm.nih.gov
Long term use of the telemonitoring system Diani in the therapy of a patient with type 1 diabetes. [2022]
Use of the GlucoWatch biographer in children with type 1 diabetes. [2022]
First Experiences With a Wearable Multisensor in an Outpatient Glucose Monitoring Study, Part I: The Users' View. [2019]
First Experiences With a Wearable Multisensor Device in a Noninvasive Continuous Glucose Monitoring Study at Home, Part II: The Investigators' View. [2019]
Noninvasive Hypoglycemia Detection in People With Diabetes Using Smartwatch Data. [2023]
The Effect of a Global, Subject, and Device-Specific Model on a Noninvasive Glucose Monitoring Multisensor System. [2018]
The use of an Energy Monitor in the management of diabetes: a pilot study. [2022]
Within-Person and Between-Sensor Variability in Continuous Glucose Monitoring Metrics. [2023]
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