What side effects are associated with this type of intervention?

Common treatments for diabetes, such as DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors, have various side effects. DPP-4 inhibitors may cause nasopharyngitis, headache, and a slight risk of pancreatitis. GLP-1 receptor agonists can lead to gastrointestinal issues like nausea, vomiting, and diarrhea, and may also increase the risk of thyroid tumors. SGLT2 inhibitors are associated with urinary tract infections, genital infections, and a risk of diabetic ketoacidosis. Monitoring blood glucose, blood pressure, and ECG readings is crucial to manage these side effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of diabetes, including GLP-1 agonists like liraglutide and extended-release exenatide, which help improve glycemic control and have cardiovascular benefits. Liraglutide, for instance, has shown efficacy in reducing hemoglobin A1c levels and improving blood lipid profiles in pediatric patients. Additionally, SGLT2 inhibitors have been approved for their role in lowering blood glucose and reducing cardiovascular events. These treatments align with the monitoring capabilities of the LIFELEAF Smartwatch, which tracks blood glucose, blood pressure, and ECG readings.

What other types of research exist?

Promising alternatives to the LIFELEAF Smartwatch for diabetes patients in 2024 include: 1) Fitbit activity trackers, which have shown potential in monitoring physical activity and correlating it with clinical data such as HbA1c and lipid levels. 2) Continuous glucose monitors (CGMs) combined with telemedicine, which have demonstrated improvements in A1C levels and are increasingly covered by insurance. 3) Wearable wireless devices validated for continuous monitoring of vital signs, which offer feasibility and reliable data collection. These alternatives provide comprehensive monitoring and can be integrated into broader disease management programs.

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Non-invasive Measurement with LIFELEAF Smartwatch for Diabetes

N/A

Waitlist Available

Led By Narayan Guru G. Kowlgi, MBBS

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-invasive monitoring with a smartwatch, there are no direct side effects from the device itself like you might expect with medications or surgeries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blood glucose level

Diastolic blood pressure

Systolic blood pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LIFELEAF Smartwatch

2023

N/A

~90

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include insulin therapy, oral hypoglycemic agents, and lifestyle modifications. Insulin therapy helps to regulate blood glucose levels by facilitating the uptake of glucose into cells. Oral hypoglycemic agents, such as metformin, work by improving insulin sensitivity and reducing glucose production in the liver. Lifestyle modifications, including diet and exercise, are crucial for managing blood glucose levels and overall cardiovascular health. Monitoring blood glucose, blood pressure, and ECG readings is essential for diabetes patients as it helps in early detection of complications, allows for timely adjustments in therapy, and supports overall disease management.

Effectiveness of mobile applications in diabetic patients' healthy lifestyles: A review of systematic reviews.Impact on guidelines: The general practitioner point of view.Diabetes Technology: Review of the 2019 American Diabetes Association Standards of Medical Care in Diabetes.