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

Trial Summary

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

Research shows that the Eversense CGM System helps people with diabetes manage their blood sugar levels effectively. In studies, it provided accurate glucose readings and improved blood sugar control over time, with many users reporting positive experiences and requesting continued use. ^{1 2 3 4 5}

Is the Eversense CGM System safe for use in humans?

The Eversense CGM System has been shown to be safe in humans, with studies reporting no serious adverse events related to the device or its insertion/removal procedures. It has been used successfully in both clinical trials and real-world settings for managing diabetes. ^{2 3 4 6 7}

How is the Eversense CGM System different from other diabetes treatments?

The Eversense CGM System is unique because it features a fully implantable sensor that can last up to 180 days, unlike other continuous glucose monitoring systems that require frequent sensor replacements. ^{1 2 3 4 6}

What is the purpose of this trial?

This study is evaluating whether a continuous glucose monitor may help people with diabetes better manage their blood sugar.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 (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 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]

References

1. 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]

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. 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]

5. England 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. [2022]

6. 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]

7. 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]