Eversense CGM for Diabetes

(NA-PAS Trial)

Recruiting at 23 trial locations

Overseen By Ralph Oiknine, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Senseonics, Inc.

Must not be taking: Dexamethasone

Disqualifiers: Critically ill, Dialysis, Pregnant, others

Stay on Your Current Meds You can continue your current medications while participating

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

925 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Eversense CGM System to evaluate its effectiveness in helping people manage diabetes compared to the usual self-monitoring with a blood glucose meter. Participants will first track their blood sugar with traditional meters for 6 months, then switch to the Eversense system for the next 6 months. This study targets individuals with Type 1 or Type 2 diabetes who have a smartphone and have not used a continuous glucose monitor (CGM) for more than a week in the past 6 months. The goal is to determine if the Eversense system can improve blood sugar management over traditional methods. As an unphased trial, this study offers a unique opportunity to explore new ways to manage diabetes effectively.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on comparing two methods of monitoring blood sugar, so you may not need to change your medications, but it's best to confirm with the trial organizers.

What prior data suggests that the Eversense CGM System is safe for diabetes management?

Research has shown that the Eversense CGM System is safe for people with diabetes. In a large real-world study with over 3,000 participants, most did not experience serious issues while using the system. Another study found that the system not only ensures safety but also provides accurate blood sugar readings, crucial for effective diabetes management. These findings suggest that the Eversense CGM System is user-friendly and a reliable choice for continuous glucose monitoring. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Eversense CGM System is unique because it offers continuous glucose monitoring (CGM) for diabetes management, unlike traditional self-monitoring blood glucose (SMBG) methods that require finger pricks multiple times a day. Researchers are excited about this treatment because it provides real-time glucose readings and trends, allowing for more precise and timely adjustments to therapy. Additionally, Eversense is implanted under the skin and can last for months, reducing the need for frequent sensor replacements and enhancing convenience for users. These features could lead to better glucose control and improved quality of life for people with diabetes.

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

Research has shown that the Eversense Continuous Glucose Monitoring (CGM) System works well for people with diabetes. Studies found the Eversense system to be very accurate, correctly identifying low and high blood sugar levels over 96% of the time. It provides real-time glucose readings, aiding users in managing their diabetes more effectively. The system continuously checks glucose levels for up to 90 days using a small sensor placed under the skin. In this trial, participants will first manage their diabetes with self-monitoring of blood glucose (SMBG) for 6 months, then switch to the Eversense CGM system for the next 6 months. Overall, the Eversense CGM System is a dependable tool for monitoring blood sugar levels in adults with diabetes. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

Adults with Type 1 or Type 2 diabetes who have never used a continuous glucose monitor (CGM) for more than one week in the last six months. Participants must own an internet-enabled smartphone and be able to follow study instructions. Critically ill patients, those on dialysis, pregnant or nursing women, and individuals with certain medical conditions are excluded.

Inclusion Criteria

I have diabetes.

Subjects is willing and able to provide written signed and dated informed consent

Subject has a smartphone that is internet enabled

Exclusion Criteria

I am critically ill or currently in the hospital.

Prior use of CGM defined as: No more than 1 week of continuous CGM use in the last 6 months, and At least 4 weeks of continuous use of CGM in the last 12 months or 12 weeks total use in the past 3 years.

I am currently receiving dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants manage their diabetes using self-monitoring of blood glucose (SMBG) for 6 months

6 months

Regular clinic visits and home monitoring

Non-adjunctive CGM Use

Participants use the Eversense CGM System non-adjunctively for 6 months

6 months

Regular clinic visits and home monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blood glucose meter
• Eversense CGM System

Trial Overview The study is testing the Eversense CGM System's effectiveness compared to traditional blood glucose meter monitoring over a year. For the first six months, participants will use their usual blood glucose meters; for the next six months, they'll switch to using Eversense CGM non-adjunctively.

How Is the Trial Designed?

Group I: Self monitoring of blood glucose, then CGM System Experimental Treatment 2 Interventions

All participants will first manage their diabetes with SMBG for 6 months followed by managing their diabetes with Eversense CGM system for the next 6 months

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 a study of 100 adults with type 1 diabetes using the Eversense CGM System for 180 days, there was a significant reduction in HbA1c levels by an average of 0.43%, indicating improved blood sugar control.

The use of the Eversense CGM also led to increased time in range (TIR) for glucose levels and decreased time above range (TAR), demonstrating enhanced glucose monitoring and management effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes. Irace, C., Cutruzzolà, A., Nuzzi, A., 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 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 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 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 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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39869118/

Evaluation of Accuracy and Safety of the 365-Day ... The confirmed alert detection rate at 70 mg/dL was 96.6%, and at 180 mg/dL, it was 97.9%. Ninety percent of the sensors survived 365 days.

2. eversensecgm.com eversensecgm.com/

Eversense Continuous Glucose Monitoring (CGM) Device ... Eversense 365 gives you real-time glucose readings through a small sensor that's placed just under the skin of your upper arm by a healthcare professional.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/P160048B.pdf

PMA P160048: FDA Summary of Safety and Effectiveness ... The Eversense CGM System is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is ...

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

Six-Month Data on Long-Term Eversense CGM System ... When referenced against a lab analyzer, the findings demonstrated the accuracy of Eversense XL (MARD of 9.4%, 15/15% metric of 83%, and 99.6% of ...

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

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

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. 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 ...

8. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05131139/enhance-study-evaluation-of-accuracy-and-safety-of-the-eversense-cgm-system-with-enhanced-features

Evaluation of Accuracy and Safety of the Eversense CGM ... The purpose of this clinical investigation is to evaluate the accuracy of the Eversense 524 Continuous Glucose Monitoring System (Eversense 524 ...