Sensing Device for Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring glucose levels with a device, so you may not need to change your medication routine.
What safety data exists for diabetes sensing devices?
There is safety data available for diabetes devices like blood glucose meters, continuous glucose monitors, and insulin pumps, which shows that while adverse events are rare, they can occur and are important to monitor. Insulin pumps, for example, can have issues like pump failure or user error, leading to serious conditions like high or low blood sugar. Public databases like the FDA's MAUDE contain reports of these events, but more transparency and research are needed to improve safety.12345
How does the Sensing Device treatment for diabetes differ from other treatments?
What data supports the effectiveness of the Sensing Device treatment for diabetes?
Research shows that using a real-time glucose-sensor system can help improve blood sugar control in people with diabetes, leading to lower levels of glycated hemoglobin (a measure of long-term blood sugar control) and fewer episodes of low blood sugar. These findings suggest that the Sensing Device could be a useful tool for managing diabetes.1011121314
Who Is on the Research Team?
Linda A DiMeglio, MD
Principal Investigator
Indiana University
Are You a Good Fit for This Trial?
This trial is for individuals with diabetes who may experience high or low blood sugar levels. The study aims to include those who could benefit from noninvasive monitoring of their glucose levels through breath analysis.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Device Usage
Participants wear the breath sensor device for 25 hours to collect data on volatile organic compounds in exhaled breath
Data Analysis
Data from the wearable breath-based sensor is analyzed to identify correlations between breath data and blood glucose levels
Follow-up
Participants are monitored for any adverse events and the effectiveness of the device is evaluated
What Are the Treatments Tested in This Trial?
Interventions
- The Sensing Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
Indiana University
Lead Sponsor