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

Trial Summary

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

How does the Sensing Device treatment for diabetes differ from other treatments?

The Sensing Device for diabetes is unique because it provides continuous glucose monitoring, offering detailed data on glucose levels without the need for frequent finger pricks, unlike traditional glucose meters that provide only point sample information. ^{1 11 12 13 14}

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.

Research Team

Linda A DiMeglio, MD

Principal Investigator

Indiana University

Eligibility Criteria

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.

Willing to return the device within 24-48 hours of study completion

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

[Therapeutic education and continuous glucose monitoring in insulin-treated diabetic patients]. [2011]

2. France pubmed.ncbi.nlm.nih.gov

Attempt to improve glucose control in type 2 diabetic patients by education about real-time glucose monitoring. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Continuous subcutaneous glucose monitoring in diabetic patients: a multicenter analysis. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Continuous noninvasive glucose monitoring technology based on "occlusion spectroscopy". [2021]

5. United States pubmed.ncbi.nlm.nih.gov

First Experiences With a Wearable Multisensor in an Outpatient Glucose Monitoring Study, Part I: The Users' View. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse Event Data for Years 2018 to 2020 for Diabetes Devices. [2022]

7. United States 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. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Non-invasive glucose monitoring: assessment of technologies and devices according to quantitative criteria. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Glucose sensors: a review of current and emerging technology. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Allergic contact dermatitis caused by isobornyl acrylate in Freestyle® Libre, a newly introduced glucose sensor. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The characteristics of a new glucose sensor for use in an artificial pancreatic beta cell. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Performance comparison of the medtronic sof-sensor and enlite glucose sensors in inpatient studies of individuals with type 1 diabetes. [2022]