Continuous Glucose Monitoring for Diabetes

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system for monitoring blood sugar levels in people with diabetes. The goal is to evaluate the effectiveness and safety of the RIGHTEST Continuous Glucose Monitoring System. Participants will use a sensor on their arm to track glucose levels and compare the results with traditional methods. Ideal candidates are adults with type 1 or type 2 diabetes who can attend all study sessions and follow study instructions. This trial is not suitable for individuals with certain health issues, such as severe diabetes complications, unstable heart problems, or kidney disease. As an unphased trial, it offers participants the opportunity to contribute to advancements in diabetes care.

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.

What prior data suggests that the RIGHTEST Continuous Glucose Monitoring System is safe for adults with diabetes?

Research shows that the RIGHTEST Continuous Glucose Monitoring System is generally safe to use. Previous studies have not found any major safety issues. The system's waterproof feature is helpful for everyday activities. If the adhesive starts to come loose, using waterproof tape is advisable to keep it in place. It is important to note that this system is not designed to diagnose diabetes or for use with newborns. Overall, evidence suggests that adults with diabetes tolerate this monitoring system well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RIGHTEST Continuous Glucose Monitoring System because it offers a real-time, dynamic way to track glucose levels, unlike traditional fingerstick methods that provide only snapshots. This system continuously monitors glucose levels, potentially allowing for better management of diabetes by providing immediate feedback and reducing the number of manual blood tests required. Additionally, it may improve accuracy and convenience, making it easier for individuals to maintain optimal glucose control and potentially improving their overall quality of life.

What evidence suggests that the RIGHTEST Continuous Glucose Monitoring System is effective for diabetes?

Research has shown that the RIGHTEST Continuous Glucose Monitoring (CGM) System, which participants in this trial will use, helps people with diabetes manage their blood sugar levels effectively. Studies have found that using CGM can significantly increase the time patients maintain their blood sugar within the desired range and lower their HbA1c levels, a measure of average blood sugar over time. This improvement leads to better overall blood sugar control. The RIGHTEST CGM System connects to a smartphone app, allowing users to easily set and track their blood sugar goals. Early results suggest it works well for those managing diabetes with insulin. ^{2 6 7 8 9}

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 available to participate in all clinical sessions

Subjects must be willing and able to provide signed written consent

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

Exclusion Criteria

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

Participation in another clinical trial within 2 weeks prior to screening

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) 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 (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]

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]

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]

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 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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06197906

Study Details | Effectiveness and Safety of the RIGHTEST ... Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1751991825000427

Diabetes self-management smartphone application The “Rightest” app connected to Rightest glucose meter via Bluetooth, helps to set blood glucose target and customize measurements.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K240637.pdf

Bionime Corporation Feng-Yu Lee Principal Regulatory ... Results of performance evaluation of RIGHTEST Blood Glucose Monitoring System Max. Tel that had no impacts to BGM measurement was conducted ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06197906/effectiveness-and-safety-of-the-rightesttm-continuous-glucose-monitoring-system-for-blood-glucose-management-in-persons-with-diabetes-mellitus

Effectiveness and Safety of the RIGHTEST™ Continuous ... Effectiveness and Safety of the RIGHTEST™ Continuous Glucose Monitoring System for Blood Glucose Management in Persons With Diabetes Mellitus.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12413689/

Efficacy of Real-Time Continuous Glucose Monitoring in ... RT-CGM significantly improved TIR and reduced HbA1c in insulin-treated patients, although benefits varied by intervention frequency and patient ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf11/K110737.pdf

MAR 2 9201? - accessdata.fda.gov The Rightest Blood Glucose Test Strip GS700 is for use with the Rightest Blood. Glucose meter GM700 to quantitatively measure glucose (sugar) in ...

7. rightest.com rightest.com/global/rightestifree2cgm/

Continuous Glucose Monitoring System. (CGM) Waterproof up to 3.05 meters for 30 hours; use waterproof tape if adhesive lifts. 5. Exclude aircraft and pressurized cabins.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/K170143.pdf

510(K) SUMMARY - accessdata.fda.gov The Rightest Blood. Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing ...

9. bionime.com bionime.com/bionime-rightest-series-do-not-use-gdh-pqq/

Bionime Rightest Series Do Not Use GDH-PQQ Bionmie RightestTM Series Do Not Use GDH-PQQ, the Enzyme that FDA Issued a Public Health Notification on Potentially Fatal Errors with ...