ELG Device for Diabetes

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: XP Technology, LLC

Must not be taking: Drugs of abuse

Disqualifiers: Recent study, Blood transfusion, Sickle Cell Anemia, others

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

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the ELG, which measures blood sugar levels without a blood sample. The researchers aim to determine how accurately the ELG compares to regular blood tests for individuals with Type 1 or Type 2 diabetes. It suits those with diabetes who can attend two daytime visits and are willing to fast for a few hours before a visit. Participants will place their thumb in the device for a quick scan, displaying both glucose and A1C levels. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does exclude those taking drugs of abuse.

What prior data suggests that the ELG device is safe for monitoring glucose levels?

Research has shown that the ELG device, which monitors blood sugar levels without blood samples, is undergoing tests for safety and effectiveness. Early studies suggest that the ELG device provides results comparable to store-bought and lab tests. This consistency indicates potential reliability and safety.

As the ELG device remains under investigation, complete information on its safety is not yet available. However, its testing suggests promise in earlier evaluations. If successful, the device could offer a non-invasive option for people with diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ELG Device for diabetes because it offers a unique, non-invasive way to monitor glucose and A1C levels. Unlike traditional methods that require blood samples, the ELG Device simply scans the thumb, making it more convenient and less painful for users. This innovative approach could lead to more frequent monitoring, better management of diabetes, and improved patient outcomes.

What evidence suggests that the ELG device is effective for monitoring glucose levels in diabetes?

Research shows that continuous glucose monitoring (CGM) devices, such as the ELG device studied in this trial, can help people with diabetes better control their blood sugar. Studies have found that using CGM can slightly lower HbA1c levels, which measure average blood sugar over a few months, by about 0.3% to 0.32%. This indicates better overall blood sugar management compared to traditional methods. Additionally, CGM devices are generally quicker and more convenient than finger-prick tests, making it easier for people to regularly check their blood sugar levels. Participants in this trial will use the ELG device to compare its effectiveness to whole blood testing. ^{1 6 7 8 9}

Who Is on the Research Team?

Dr. Peter P Xaysanasy, DPM

Principal Investigator

XP Technology, LLC

Dr. Joe P Rouse, MD

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for adults aged 25-65 with type 1 or type 2 diabetes. Participants must be available for two visits over 2-4 weeks, willing to fast for at least six hours before the first visit, and able to undergo a venous blood draw and up to four fingersticks per visit.

Inclusion Criteria

I am either male or female.

Daytime availability for visits

I have been diagnosed with diabetes.

Exclusion Criteria

Participation in another research study in the last 30 days

Taking drugs of abuse (illegal and/or prescription)

I have sickle cell anemia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ELG device to monitor glucose levels during fasting and non-fasting events

4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ELG

Trial Overview

The study tests the ELG medical device that monitors glucose levels in diabetic patients without needing blood samples. It compares this non-invasive method's accuracy against traditional blood testing methods.

How Is the Trial Designed?

Group I: ELG Device Comparison to Whole Blood Testing Experimental Treatment 1 Intervention

Participant will place thumb in the ELG device for scan. Scan generally takes between 1-2 minutes. ELG then displays a readout of both a glucose and A1C reading on the screen of the ELG device.

Who Is Running the Clinical Trial?

XP Technology, LLC

Lead Sponsor

Trials

1

Recruited

100+

Published Research Related to This Trial

The use of a next-generation closed-loop insulin pump (MiniMed 780G) significantly improved the patient's glucose control over 4 months, reducing mean daily glucose levels from 201 mg/dL to 141 mg/dL and lowering HbA1c from 121 mmol/mol to 56 mmol/mol.

The patient experienced a marked increase in time spent within the target glucose range (from 43% to 78%) and a decrease in hyperglycemia (from 52% to 20%), demonstrating the efficacy of the advanced hybrid closed-loop system in managing severe type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced technology for type 1 diabetes care in a deaf-mute patient. Pintaudi, B., Nani, A., Gironi, I., et al.[2022]

SGLT2 inhibitors, a new class of oral medications for type 2 diabetes, effectively lower blood glucose levels by preventing the reabsorption of glucose and sodium in the kidneys, and they also provide cardiovascular and renal protection.

While SGLT2 inhibitors are generally well-tolerated, they carry risks of serious side effects such as hypoglycemia, hypotension, and infections, necessitating careful patient monitoring to manage these potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary. Mascolo, A., Di Napoli, R., Balzano, N., et al.[2022]

In a study involving six subjects with type 1 diabetes, the Navigator continuous glucose monitoring (CGM) device demonstrated the highest accuracy with a mean absolute relative difference (MARD) of 11.8%, compared to 16.5% for the Seven Plus and 20.3% for the Guardian.

The Navigator and Guardian devices showed nearly 100% data reporting reliability, while the Seven Plus had a lower reliability at 76%, highlighting significant differences in performance among the CGM devices tested.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative effectiveness analysis of three continuous glucose monitors. Damiano, ER., El-Khatib, FH., Zheng, H., et al.[2022]

In a study involving 110 patients with type 1 diabetes, the Medtronic 640G system's predictive low-glucose suspend (PLGS) feature was found to effectively balance the risks of hypoglycemia and hyperglycemia, with optimal PLGS duration between 157.5 and 174.4 minutes per day.

The analysis revealed that a lower basal insulin percentage and longer PLGS duration were associated with reduced hyperglycemia, while specific PLGS settings could be adjusted through total daily insulin dose to enhance overall glucose management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensor-Augmented Insulin Pump with Predictive Low-Glucose Suspend (PLGS): Determining Optimal Settings of Pump and Sensor in a Multicenter Cohort of Patients with Type 1 Diabetes. Joubert, M., Briant, AR., Kessler, L., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05055804

The ELG Analysis of Glucose a Correlational to Blood ...

This study is an investigational study of the ELG medical device to monitor glucose blood level in diabetes mellitus Type 1 and 2 without blood samples in ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S016882272400809X

The effectiveness of continuous glucose monitoring with ...

Among them, the average effectiveness of CGM appears to be approximately 0.3 % [3.3 mmol/mol] reduction in HbA1c compared to the comparator arm [21]. For ...

3.

jamanetwork.com

jamanetwork.com/journals/jama/fullarticle/2598770

Effect of Continuous Glucose Monitoring on Glycemic ...

Continuous glucose monitoring resulted in better glycemic control compared with usual care, but further research is needed to assess clinical outcomes.

4.

frontiersin.org

frontiersin.org/journals/clinical-diabetes-and-healthcare/articles/10.3389/fcdhc.2025.1517161/full

Comparing glucose monitoring methods: efficiency insights ...

Sensor application (Task A) was significantly faster than finger-prick glucose monitoring (Task C) across all measured components. Consent time ...

5.

academic.oup.com

academic.oup.com/jcem/article/109/4/1119/7438972

Effectiveness of Continuous Glucose Monitoring on Metrics of ...

Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf16/P160017S091B.pdf

summary of safety and effectiveness data (ssed)

The Guardian Link (3) Transmitter powers the glucose sensor, collects and calculates sensor data, and wirelessly sends the data to the MiniMed 780G insulin pump ...

7.

diabetes.org.uk

diabetes.org.uk/about-us/news-and-views/investigating-accuracy-and-safety-data-behind-cgm-devices-uk

Investigating the accuracy and safety data behind CGM ...

Some continuous glucose monitoring (CGM) devices available for people living with type 1 diabetes in the UK do not have sufficient accuracy and safety data ...

8.

xp-tech.org

xp-tech.org/elg3

ELG3

Pre-clinical and clinical trial data (pending completion of clinical trial) indicate ELG results are comparable to OTC and lab results consistent to NIH-VA ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10043869/

Emerging Diabetes Technologies: Continuous Glucose ...

A device that measures glucose values in the subcutaneous space via a sensor and is transmitted to a receiver/smartphone.