Continuous Glucose Monitoring for Diabetes

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

350 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing devices that monitor blood sugar levels in adults with diabetes and children with Type 1 Diabetes. The goal is to see how accurate and safe these devices are for managing diabetes. These devices allow people with diabetes to keep track of their blood glucose levels in near real-time.

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 data supports the effectiveness of the Eversense CGM System for diabetes management?

The Eversense CGM System has shown promising results in managing diabetes by providing accurate and consistent glucose monitoring over multiple cycles, with a high percentage of time spent in the target glucose range and no serious adverse events reported. This system is valued for its long-term implantable sensor, which offers real-time data to help people with diabetes manage their condition effectively. ^{1 2 3 4 5}

Is the Eversense Continuous Glucose Monitoring System safe for humans?

The Eversense Continuous Glucose Monitoring System has been shown to be safe in clinical trials, with no serious adverse events related to the device or its insertion/removal procedures reported. Real-world data also support its safety, making it a valuable tool for managing diabetes. ^{1 2 3 6 7}

What makes the Eversense CGM System unique compared to other diabetes treatments?

The Eversense CGM System is unique because it features a fully implantable sensor that can last up to 180 days, providing continuous glucose monitoring without the need for frequent sensor replacements, unlike other CGM systems that require more frequent changes. ^{1 2 4 5 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 (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 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 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]

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 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]

References

1. England 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. [2022]

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

Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor. [2020]

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

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

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

Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor over Multiple Sensor Insertion and Removal Cycles. [2021]

5. England 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. [2022]

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

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

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

A Prospective Multicenter Evaluation of the Accuracy and Safety of an Implanted Continuous Glucose Sensor: The PRECISION Study. [2020]