Sensing Device for Diabetes

Overseen By Mangilal Agarwal, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Smokers, Respiratory illness, Ketogenic diet, others

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

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new device that detects blood sugar levels by analyzing breath. It targets individuals with type 1 diabetes to determine if the device can identify high or low blood sugar without needing a blood sample. The trial seeks children and teens, aged 12-19, who already use a specific type of glucose monitor and reside in or near Indianapolis, IN. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes research without the constraints of traditional clinical trial phases.

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 prior data suggests that this sensing device is safe for diabetic children?

Research has shown that diabetes sensing devices, like the one in this trial, are generally safe to use. Studies have found that people usually tolerate these devices well. They function similarly to continuous glucose monitors (CGMs) that many people with diabetes already use.

For this specific device, current safety data reports no serious side effects. However, users should be aware of small parts that could pose a choking hazard. Ensuring the device functions correctly is crucial to avoid missing signs of very low blood sugar.

Overall, evidence suggests these devices are safe, but users should carefully follow all instructions to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sensing Device is unique because it offers a noninvasive way to monitor blood glucose levels, unlike traditional methods that require finger pricks or continuous glucose monitors with needles. This wearable sensor allows users to simply breathe into it, making glucose monitoring more comfortable and accessible, particularly for children with diabetes. Researchers are excited about this innovation as it could greatly enhance the quality of life for diabetic patients by reducing the pain and inconvenience associated with frequent blood glucose testing.

What evidence suggests that this sensing device is effective for detecting glucose levels in diabetes?

Research has shown that continuous glucose monitoring (CGM) devices greatly assist people with diabetes in managing their blood sugar levels. Studies have found that these devices lead to better blood sugar control and higher user satisfaction. CGMs enable individuals to detect high or low blood sugar levels, allowing them to act before issues arise. This reduces the risk of low blood sugar (hypoglycemia) or high blood sugar (hyperglycemia). In this trial, participants will use a sensing device that aims to achieve similar results by monitoring blood sugar changes through breath, offering a noninvasive way to manage diabetes. ^{6 7 8 9 10}

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

I am between 12 and 19 years old.

Utilize a Dexcom (G6 or G7) continuous glucose monitoring device

Have an established working CGM for at least 12 hours

Exclusion Criteria

Themselves or a close family member is on a 'ketogenic diet'

Themselves or a close family member works in an industry with high and continuous exposure to exogenous VOCs

Smokers or use tobacco products or live with someone who smokes

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Device Usage

Participants wear the breath sensor device for 25 hours to collect data on volatile organic compounds in exhaled breath

25 hours

1 visit (in-person)

Data Analysis

Data from the wearable breath-based sensor is analyzed to identify correlations between breath data and blood glucose levels

1-2 weeks

Follow-up

Participants are monitored for any adverse events and the effectiveness of the device is evaluated

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• The Sensing Device

Trial Overview

The trial is testing a new sensing device designed to detect changes in blood sugar by analyzing volatile organic compounds in exhaled breath, potentially offering a noninvasive way to monitor glycemic events.

How Is the Trial Designed?

Group I: Diabetic Children with Continuous Glucose Monitors Experimental Treatment 1 Intervention

These subjects will be given the Sensing Device, a wearable sensor that subjects can breathe into, which is being investigated in the current study as a potential medical device for noninvasive measurement of blood glucose.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Published Research Related to This Trial

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

A study involving 15 patients revealed that the FreeStyle® Libre glucose sensor can cause allergic contact dermatitis, primarily due to its adhesive component.

Isobornyl acrylate was identified as a significant allergen in these cases, with 12 out of 13 tested patients showing sensitization to it, highlighting the need for awareness of potential allergic reactions to this medical device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. Herman, A., Aerts, O., Baeck, M., et al.[2022]

A study involving 549 participants from the TuDiabetes.org online community found that 75 reported device-related adverse events, with nearly half requiring intervention, highlighting the potential for online networks to capture real-world device issues.

Only 4% of these adverse events were reported to the FDA, suggesting that online participatory surveillance can provide more comprehensive outcome data compared to traditional reporting methods, which often lack detailed information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. Mandl, KD., McNabb, M., Marks, N., et al.[2021]

Glucose meter evaluations show that while many devices perform well according to standards, there are still significant malfunctions reported, with 10,837 adverse events documented in the FDA's MAUDE database in just the first 7 months of 2018.

Using reliability growth management techniques could help reduce the failure rates of glucose meters by analyzing and addressing the issues highlighted in the MAUDE database.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing Glucose Meter Adverse Events by Using Reliability Growth With the FDA MAUDE Database. Krouwer, JS.[2020]

The use of a real-time glucose-sensor system significantly improved glucose control in patients with type 1 and type 2 diabetes, leading to reduced HbA1c levels and fewer hypoglycemic episodes.

Despite some technical challenges, particularly in type 2 diabetes patients, the positive outcomes suggest that glucose sensors could be an effective educational tool for managing diabetes, warranting further research in larger studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic education and continuous glucose monitoring in insulin-treated diabetic patients]. Thielen, V., Radermecker, RP., Renard, E., et al.[2011]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10460137/

The Effectiveness of Continuous Glucose Monitoring ...

The findings indicated significant improvements in glycemic control with the adoption of CGM devices, highlighting their potential benefits for ...

2.

e-enm.org

e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ...

Studies show that people with diabetes (PwD) using CGM achieve better glycemic outcomes and greater satisfaction with their diabetes management.

3.

diabetesjournals.org

diabetesjournals.org/care/article/47/1/169/154009/Efficacy-and-Safety-of-Continuous-Glucose

Efficacy and Safety of Continuous Glucose Monitoring and ...

Both CGM and isCGM demonstrated a reduction in HbA 1c levels in individuals with T2D, and unlike CGM, isCGM use was associated with improved user satisfaction.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0168822722006374

Clinical and economic outcomes of continuous glucose ...

CGMS in patients with diabetes is associated with a valuable clinical implications in reducing hypoglycemic events, glucose and HbA1c level.

5.

diabetes.org

diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM)

With a CGM, one can see in real time if they're trending high or low and take preventative measures against hypoglycemia (low blood glucose) and hyperglycemia ( ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5250611/

Safety of using real-time sensor glucose values ...

This study explored the safety of using real-time sensor glucose (SG) data for treatment decisions in adolescents with poorly-controlled type 1 diabetes.

7.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160007S047b.pdf

Summary of Safety and Effectiveness Data (SSED)

The sensor is a sterile, all-in-one glucose sensing device, intended as a single-patient, single-use component of a personal CGM system for the ...

8.

diabetes.org

diabetes.org/sites/default/files/2024-04/CGM-guidance-4-24.pdf

Guidance for the Use of Continuous Glucose Monitoring in ...

The purpose of this guidance document is to provide general information about the use of continuous glucose monitors (CGMs) in the school setting to monitor ...

9.

withpower.com

withpower.com/trial/phase-diabetes-4-2025-9b688

Sensing Device for Diabetes · Info for Participants

What safety data exists for diabetes sensing devices? There is safety data available for diabetes devices like blood glucose meters, continuous glucose ...

10.

dexcom.com

dexcom.com/en-is/safety-information

Safety Information

The sensor and transmitter include small parts that may pose a choking hazard. The following may result in: missing severe hypoglycemia (low blood glucose) or ...