Non-invasive Measurement with LIFELEAF Smartwatch for Diabetes

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.

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.

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.

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.

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.²³⁶⁷⁸