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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the ELG treatment for diabetes?

Research shows that devices like continuous glucose monitors and insulin pumps, which are similar to the ELG device, help reduce low blood sugar episodes and improve overall blood sugar control in people with diabetes. ^{1 2 3 4 5}

What is the safety profile of SGLT2 inhibitors?

SGLT2 inhibitors, used for diabetes, generally have a good safety profile but can cause side effects like low blood sugar, low blood pressure, infections, and in rare cases, serious conditions like diabetic ketoacidosis. They are well-tolerated and offer heart and kidney benefits, but patients should be monitored for potential risks. ^{6 7 8 9 10}

How is the ELG treatment for diabetes different from other treatments?

The ELG treatment for diabetes is unique because it likely involves a device similar to sensor-augmented insulin pumps, which use continuous glucose monitoring to automatically adjust insulin delivery. This approach can help reduce both low and high blood sugar episodes, offering a more precise and responsive management of diabetes compared to traditional insulin therapy. ^{1 3 11 12 13}

What is the purpose of this trial?

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 comparison to blood testing methods."Investigational" means the ELG medical device is subjected by the FDA (Food and Drug Administration) for premarket testing requirements. The purpose of this study is to collect data comparison values between ELG testing device to current blood testing methods.

Research Team

Dr. Peter P Xaysanasy, DPM

Principal Investigator

XP Technology, LLC

Dr. Joe P Rouse, MD

Principal Investigator

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial. [2022]

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

Managing Patients with Insulin Pumps and Continuous Glucose Monitors in the Hospital: to Wear or Not to Wear. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Real-world performance of the MiniMed™ 670G system in Europe. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

The Predictive Low Glucose Management System in Prevention of Clinically Significant Hypoglycemia in Type 1 Diabetes. A Preliminary Study Identifying the Most Common Events Leading Up to Hypoglycemia During Insulin Pump Therapy. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety profile of sodium glucose co-transporter 2 (SGLT2) inhibitors: A brief summary. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Sodium glucose co-transporter 2 inhibitor luseogliflozin in the management of type 2 diabetes: a drug safety evaluation. [2018]

8. England pubmed.ncbi.nlm.nih.gov

The current role of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes mellitus management. [2022]

9. France pubmed.ncbi.nlm.nih.gov

Adverse effects and safety of SGLT-2 inhibitors. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Physicians' Considerations and Practice Recommendations Regarding the Use of Sodium-Glucose Cotransporter-2 Inhibitors. [2022]

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

Advanced technology for type 1 diabetes care in a deaf-mute patient. [2022]

12. Denmark pubmed.ncbi.nlm.nih.gov

Recommendations for the use of sensor-augmented pumps with predictive low-glucose suspend features in children: The importance of education. [2018]

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

A comparative effectiveness analysis of three continuous glucose monitors. [2022]