Continuous Glucose Monitoring for Diabetes

Not currently recruiting at 3 trial locations

Overseen By Katherine Tweden

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Senseonics, Inc.

Must not be taking: Immunosuppressants, Chemotherapy, Anticoagulants, others

Disqualifiers: Severe hypoglycemia, Ketoacidosis, Gastroparesis, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the accuracy and safety of the Eversense Continuous Glucose Monitoring (CGM) systems for people with diabetes. It compares these devices to standard glucose measurements to evaluate their effectiveness. The trial includes adults with any type of diabetes and teenagers with Type 1 diabetes. Ideal candidates have lived with diabetes for over a year and are interested in trying new technology to manage their condition. As an unphased trial, this study offers participants a unique opportunity to contribute to the advancement of diabetes management technology.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressant therapy, chemotherapy, anticoagulant/antithrombotic therapy (except aspirin), or antibiotics for chronic infection, you may not be eligible to participate.

What prior data suggests that these continuous glucose monitoring systems are safe for use in people with diabetes?

Research has shown that the Eversense Continuous Glucose Monitoring (CGM) System is generally safe for users. In a large study with 3,023 participants, the system proved safe for everyday use. Another study confirmed that the Eversense system is not only safe but also reliable for long-term use, lasting up to six months. Users reported few problems, and the system demonstrated high accuracy. Overall, these studies suggest that most people can use the Eversense CGM without issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional fingerstick glucose monitoring, the Eversense CGM System offers continuous glucose monitoring for people with diabetes, providing real-time data and alerts without the need for frequent manual testing. This system is unique because it includes an implanted sensor that can last for months, reducing the need for frequent sensor replacements common with other CGM systems. Researchers are excited about this technology as it aims to provide more consistent and accurate glucose readings, potentially improving diabetes management and quality of life for users.

What evidence suggests that the Eversense CGM System is effective for diabetes?

Studies have shown that the Eversense CGM System, which participants in this trial may use, effectively manages diabetes. It lowers HbA1c levels, a measure of long-term blood sugar control, by about 0.2% to 0.45%. The system is accurate and safe, with a low chance of sensor failure. Real-world data confirms that users achieve excellent blood sugar management. Additionally, it is safe and accurate for both adults and teens with Type 1 diabetes, making it a reliable choice for continuous glucose monitoring. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults and adolescents with diabetes (Type 1 or Type 2) can join this trial. Adults must have had diabetes for at least a year, while teens aged 14-17 need a confirmed diagnosis of Type 1 Diabetes for the same duration. Participants must consent to follow study rules. Those with certain health issues, drug abuse history, severe hypoglycemia, specific infections like hepatitis or HIV, allergies to anesthetics or glucocorticoids, recent heart problems, uncontrolled hypertension, or who are pregnant cannot join.

Inclusion Criteria

I am a teenager with type 1 diabetes diagnosed over a year ago.

Subject has signed an informed consent or assent form and parent/guardian has signed an informed consent, as applicable, and subject is willing to comply with protocol requirements.

I have been diagnosed with diabetes for at least a year.

Exclusion Criteria

Any condition that in the investigator's opinion would make the subject unable to complete the study or would make it not in the subject's best interest to participate in the study. Conditions include but are not limited to psychiatric conditions, known current or recent alcohol abuse or drug abuse by subject history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion

You have a condition that needs or may need a magnetic resonance imaging (MRI) scan.

I have a seizure disorder but have clearance from a neurologist to join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Eversense 524 CGM System and ROME CGM System to evaluate accuracy and safety

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eversense CGM System

Trial Overview The Eversense CGM System is being tested for its accuracy and safety in monitoring blood sugar levels compared to standard glucose tests. This includes new features in the system designed to improve user experience. The study involves adults and some teenagers with diabetes and will compare readings from the device with traditional reference measurements.

How Is the Trial Designed?

Group I: Continuous Glucose Monitoring Device Experimental Treatment 1 Intervention

Eversense 524 CGM System and ROME CGM System.

Eversense CGM System is already approved in United States, European Union for the following indications:

Approved in United States as Eversense Continuous Glucose Monitoring System for:

• Continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days

Approved in European Union as Eversense XL for:

• Continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 180 days

Who Is Running the Clinical Trial?

Senseonics, Inc.

Lead Sponsor

Trials

10

Recruited

2,000+

Published Research Related to This Trial

In 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

The Eversense® Continuous Glucose Monitoring (CGM) System demonstrated promising glycemic control in a real-world study of 205 patients, with a mean sensor glucose level of 161.8 mg/dL and a time in the target glucose range (70-180 mg/dL) of 62.3%.

The system showed good sensor accuracy with a mean absolute relative difference of 11.2% compared to home blood glucose meters, and importantly, there were no serious adverse events reported, indicating a strong safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor. Sanchez, P., Ghosh-Dastidar, S., Tweden, KS., et al.[2020]

The Eversense continuous glucose monitoring (CGM) System has been shown to be safe and effective for managing diabetes, with positive feedback from patients regarding its ease of use and reliability over both short and long-term periods.

In clinical trials, patients reported a favorable experience with the Eversense CGM, leading to a high request rate for sensor replacement after 90 or 180 days, indicating strong patient acceptance compared to traditional subcutaneous CGM systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of the Long-Term Implantable Senseonics Continuous Glucose Monitoring System and Other Continuous Glucose Monitoring Systems. Joseph, JI.[2021]

The Eversense continuous glucose monitoring (CGM) system, which features a fully implantable sensor with a lifespan of up to 180 days, has shown a mean absolute relative difference (MARD) of 8.5% to 9.4%, indicating good accuracy in glucose monitoring.

Clinical trials reported no serious device-related adverse events, with minor issues such as site irritation (0.66%) and infection (0.96%), suggesting that the Eversense system is safe for long-term use in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device profile of the eversense continuous glucose monitoring system for glycemic control in type-1 diabetes: overview of its safety and efficacy. Irace, C., Cutruzzolà, A., Tweden, K., et al.[2022]

The Eversense® Continuous Glucose Monitoring System has shown consistent accuracy in measuring glucose levels over multiple sensor cycles, with a mean absolute relative difference of around 11.5% to 11.9% compared to self-monitoring blood glucose, indicating reliable performance for diabetes management.

In a study involving 945 users over several cycles, the implantable sensor maintained stable glucose management metrics, demonstrating no degradation in performance, which is crucial for long-term diabetes care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles. Tweden, KS., Deiss, D., Rastogi, R., et al.[2021]

The Eversense® continuous glucose monitoring (CGM) system demonstrated high accuracy, with 85% of readings within 15/15% of reference values and a mean absolute relative difference (MARD) of 9.6% over a 90-day period in a study involving 35 participants with type 1 or type 2 diabetes.

The study confirmed a favorable safety profile, as there were no serious adverse events related to the device or its procedures, supporting the system's reliability for long-term glucose monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. Christiansen, MP., Klaff, LJ., Bailey, TS., et al.[2020]

The Eversense XL implantable continuous glucose monitoring (CGM) system demonstrated a mean absolute relative difference (MARD) of 9.4% over 180 days, indicating good accuracy in monitoring glucose levels in adolescents and adults with type 1 diabetes.

The system showed high agreement rates (around 83%) with blood glucose measurements and had no serious adverse events related to the device or its insertion/removal, confirming its safety for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First assessment of the performance of an implantable continuous glucose monitoring system through 180 days in a primarily adolescent population with type 1 diabetes. Aronson, R., Abitbol, A., Tweden, KS.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38579290/

Impact on diabetes control and patient-reported outcomes ... Conclusions: The use of the Eversense® CGM System resulted in changes in HbA1c of between -0.2% and -0.45%. The rate of premature sensor breakdown was low.

2. smw.ch smw.ch/index.php/smw/article/download/3366/5871/20453

Impact on diabetes control and patient-reported outcomes ... This study aimed to evaluate effectiveness, safety and pa- tient-reported outcomes in patients using the Eversense®. CGM System in a realistic ...

3. senseonics.com senseonics.com/investor-relations/news-releases/2019/08-21-2019-230021919

Senseonics Publishes Eversense® CGM Real-World Data ... Conclusion – The Eversense real-world data showed excellent glycemic results, sensor accuracy, and safety. This data demonstrates that the ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30938036/

First assessment of the performance of an implantable ... Conclusion: The Eversense XL CGM system is safe and accurate through 180 days in a primarily adolescent population of subjects with T1D. Keywords: clinical ...

5. provider.eversensecgm.com provider.eversensecgm.com/siteassets/eversense-hcp-resource-library/bailey-et-al-2025-evaluation-of-accuracy-and-safety-of-the-365-day-implantable-eversense-continuous-glucose-monitoring.pdf

Evaluation of Accuracy and Safety of the 365-Day Implantable ... The Eversense 365 CGM was shown to be safe and accurate through 1 year with primarily one calibration per week. Keywords: CGM, implantable sensor, iCGM, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6945795/

Real-World Safety of an Implantable Continuous Glucose ... The results of this large registry study demonstrated a favorable safety profile for the Eversense CGM system under real-world use in 3023 patients for 5417 ...

7. senseonics.com senseonics.com/investor-relations/news-releases/2018/06-25-2018-133715147

Six-Month Data on Long-Term Eversense CGM System ... “The Eversense System was observed to be a safe and durable alternative to currently available CGM systems and demonstrated excellent accuracy.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8817689/

Evaluation of Accuracy and Safety of the Next-Generation Up ... Conclusion: These data show the next-generation Eversense CGM system had sustained accuracy and safety up to 180 days, with an improved calibration scheme ...

9. eversensecgm.com eversensecgm.com/

Eversense Continuous Glucose Monitoring (CGM) Device ... Eversense CGMs have exceptional accuracy, with almost no false alerts from compression lows while you're sleeping.4. Eversense CGM transmitter. Maximum comfort.