Continuous Glucose Monitoring for Diabetes

Recruiting at 16 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bionime Corporation

Must not be taking: SGLT2 inhibitors

Disqualifiers: Pregnancy, Kidney disease, Cardiovascular disease, Seizure disorder, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness and safety of the RIGHTEST Continuous Monitoring (CGM) System in adult population with diabetes mellitus.

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, if you are on insulin-dependent type 2 diabetes treatment with SGLT2 inhibitors, you may not be eligible to participate.

Is continuous glucose monitoring generally safe for humans?

Continuous glucose monitoring systems have been evaluated for safety, and while some users have reported issues like inaccurate readings and allergic skin reactions, these events are relatively infrequent. Most results fall within acceptable error ranges, indicating that these systems are generally safe for human use. ^{1 2 3 4 5}

How is the RIGHTEST Continuous Glucose Monitoring System different from other diabetes treatments?

The RIGHTEST Continuous Glucose Monitoring System is unique because it continuously tracks glucose levels in real-time, providing immediate feedback and allowing for quick adjustments in insulin, diet, or activity. This system helps detect low blood sugar events that might go unnoticed, especially during sleep, and offers a comprehensive view of glucose patterns to improve long-term diabetes management. ^{6 7 8 9 10}

What data supports the effectiveness of the RIGHTEST Continuous Glucose Monitoring System treatment?

Research shows that continuous glucose monitoring can help people with diabetes better manage their blood sugar levels. In one study, using continuous glucose monitors helped improve blood sugar control in patients with type 1 diabetes, as it allowed them to adjust their insulin doses and diet based on real-time data. ^{8 11 12 13 14}

Are You a Good Fit for This Trial?

Adults with either Type 1 or Type 2 diabetes who can attend all study visits, wear two sensors on their arms, and understand English. They must be willing to provide written consent and able to follow device instructions.

Inclusion Criteria

Subjects must be willing and able to provide signed written consent

Subjects must be available to participate in all clinical sessions

Subjects must be able to speak, read, and write English

Exclusion Criteria

I have been diagnosed with hemophilia or another bleeding disorder.

Any condition that, in the opinion of the Investigator, would interfere with participation in the study or pose excessive risk to study staff

Plans to donate blood during the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the RIGHTEST Continuous Glucose Monitoring System for up to 15 days and participate in 4 in-clinic visits with frequent venous blood draws

2 weeks

4 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

• RIGHTEST Continuous Glucose Monitoring System

Trial Overview The trial is testing the RIGHTEST Continuous Glucose Monitoring System's effectiveness and safety in managing blood glucose levels for adults with diabetes.

How Is the Trial Designed?

Group I: CGM System Experimental Treatment 1 Intervention

Blood draw and glucose challenge will be performed to evaluate the performance of the CGM system compared to reference measurements during the in in-clinic visits.

Who Is Running the Clinical Trial?

Bionime Corporation

Lead Sponsor

Trials

4

Recruited

370+

Published Research Related to This Trial

Continuous glucose monitoring (CGM) significantly reduced HbA(1c) levels by an average of 0.30% compared to self-monitoring of blood glucose, particularly benefiting patients with higher baseline HbA(1c) levels and more frequent sensor usage.

CGM also led to a 23% reduction in exposure to hypoglycemia, indicating it not only helps in better glucose control but also enhances safety by reducing the risk of low blood sugar episodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. Pickup, JC., Freeman, SC., Sutton, AJ.[2022]

In a 5-week pilot study involving 9 subjects with type 1 diabetes, continuous glucose monitoring led to a significant reduction in HbA1c from 9.9% to 8.8%, indicating improved glycemic control without changing daily insulin usage.

The continuous glucose monitors accurately identified glucose patterns, allowing for therapy adjustments that would not have been possible with traditional blood glucose meter data, suggesting a valuable tool for managing diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. Bode, BW., Gross, TM., Thornton, KR., et al.[2022]

The novel noninvasive Aprise sensor demonstrated a mean relative absolute difference (RAD) of 19.9% in tracking glucose levels in 62 subjects with diabetes, indicating its potential effectiveness in monitoring glucose excursions.

The sensor showed a high percentage of readings (66.5%) within the clinically acceptable ranges (A and B) on the Clarke error grid, suggesting it could enhance patient compliance and diabetes management compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Noninvasive continuous glucose monitoring using photoacoustic technology-results from the first 62 subjects. Weiss, R., Yegorchikov, Y., Shusterman, A., et al.[2016]

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 analysis of adverse events for the Medtronic 670G insulin pump revealed that users experienced more hypoglycemic events when the auto mode was activated compared to when it was turned off.

For the Dexcom continuous glucose monitors, complaints about inaccuracies were most common when the readings fell within the acceptable range (B zone), indicating potential confusion among users regarding the reliability of the device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. Krouwer, JS.[2022]

Continuous glucose monitoring (CGM) is a groundbreaking technology for diabetes management, providing real-time blood glucose levels and helping to reduce the risk of hypoglycemia.

CGM not only allows for immediate adjustments in insulin, diet, or exercise but also aids in identifying undetectable hypoglycemic events, particularly during sleep, which can significantly enhance long-term diabetes treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of tissue glucose]. Bendzala, M., Ocadlík, I., Krahulec, B.[2010]

Continuous glucose monitoring systems provide real-time glucose readings from interstitial fluid, significantly improving diabetes management for both type 1 and type 2 diabetes patients.

These systems help patients and healthcare providers analyze glucose patterns, leading to better glycemic control, reduced hemoglobin A1c levels, and fewer instances of hypoglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring for the Internist. Lee, GS., Lupsa, BC.[2022]

Continuous glucose monitoring (CGM) was analyzed in 53 diabetic patients, primarily those with type 1 diabetes (90.5%), and was found to be effective in detecting asymptomatic hypoglycemic events and guiding therapy changes in 64.5% of cases.

The method provided additional information that improved glycemic control and potentially life expectancy in type 1 diabetes patients, but it was noted to be less effective for type 2 diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. Bagosi, Z., Oroszlán, T., Bujtor, Z., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data. [2022]

2. Ireland pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring used to adjust diabetes therapy improves glycosylated hemoglobin: a pilot study. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Real-time continuous glucose monitoring using GuardianRT: from research to clinical practice. [2007]

4. France pubmed.ncbi.nlm.nih.gov

Accuracy of continuous nocturnal glucose screening after 48 and 72 hours in type 2 diabetes patients on combined oral and insulin therapy. [2022]

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

Noninvasive continuous glucose monitoring using photoacoustic technology-results from the first 62 subjects. [2016]

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

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

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

A Real-World Setting Study: Which Glucose Meter Could Be the Best for POCT Use? An Easy and Applicable Protocol During the Hospital Routine. [2019]

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

Continuous glucose monitoring: quality of hypoglycaemia detection. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Assessment of different techniques for subcutaneous glucose monitoring in Type 1 diabetic patients during 'real-life' glucose excursions. [2013]

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

An Analysis of 2019 FDA Adverse Events for Two Insulin Pumps and Two Continuous Glucose Monitors. [2022]

11. Czech Republic pubmed.ncbi.nlm.nih.gov

[Continuous monitoring of tissue glucose]. [2010]

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

Continuous Glucose Monitoring for the Internist. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Is it possible to constantly and accurately monitor blood sugar levels, in people with Type 1 diabetes, with a discrete device (non-invasive or invasive)? [2021]

14. Hungary pubmed.ncbi.nlm.nih.gov

[The role of continuous glucose monitoring in the therapy of diabetes mellitus]. [2022]