What side effects are associated with this type of intervention?

Common treatments for diabetes include continuous glucose monitoring (CGM) systems like the Eversense CGM System, insulin therapy, and various oral and injectable medications such as DPP-4 inhibitors, GLP-1 analogues, and SGLT2 inhibitors. Known side effects of CGM systems are generally minimal but can include skin irritation at the sensor site. Insulin therapy can cause hypoglycemia and weight gain. DPP-4 inhibitors and GLP-1 analogues may lead to gastrointestinal issues, pancreatitis, and potential pancreatic cancer risks. SGLT2 inhibitors can cause urinary tract infections, genital infections, and an initial decrease in eGFR, which usually recovers.

What prior FDA approvals exist?

The FDA has approved several continuous glucose monitoring (CGM) systems for diabetes management, including the Eversense CGM System. Other notable CGM systems include the Dexcom G6 and the FreeStyle Libre. These devices provide real-time glucose readings, helping patients manage their diabetes more effectively. Additionally, the FDA has approved various glucagon-like peptide-1 (GLP-1) receptor agonists, such as liraglutide (Victoza) and exenatide (Bydureon), which improve glycemic control in patients with type 2 diabetes. These treatments, along with CGM systems, represent significant advancements in diabetes care.

What other types of research exist?

Promising alternatives to the Eversense CGM System for diabetes patients in 2024 include the Dexcom G7, which offers improved accuracy and a smaller, more discreet design, and the Abbott FreeStyle Libre 3, known for its real-time glucose readings and ease of use. Both systems have received positive feedback for their user-friendly interfaces and integration with other diabetes management tools.

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Continuous Glucose Monitoring System

Eversense CGM for Diabetes (NA-PAS Trial)

Verified Trial

N/A

Recruiting

Research Sponsored by Senseonics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject has diabetes

Subject is ≥18 years of age

Must not have

Subjects requiring intravenous mannitol or mannitol irrigation solutions

Timeline

Screening 1 day

Treatment 12 months

Follow Up 30 days

Awards & highlights

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation from sensor insertion for the Eversense CGM system and possible allergic reactions to dexamethasone used in sensor adhesive if there's known sensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have diabetes.

Select...

I am 18 years old or older.

Select...

You have a smartphone that can connect to the internet.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I need mannitol IV or for irrigation.

Timeline

Screening ~ 1 day4 visits

Treatment ~ 12 months4 visits

Follow Up ~ 30 days0 visits

Screening ~ 1 day

Treatment ~ 12 months

Follow Up ~30 days

This trial's timeline: 1 day for screening, 12 months for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of moderate and severe hypoglycemic and diabetic ketoacidosis events

Trial Design

1Treatment groups

Experimental Treatment

Group I: Self monitoring of blood glucose, then CGM SystemExperimental Treatment2 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood glucose meter

2018

N/A

~180

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include insulin therapy, GLP-1 receptor agonists, and SGLT2 inhibitors. Insulin therapy involves administering insulin to help glucose enter cells, thereby lowering blood glucose levels. GLP-1 receptor agonists enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps regulate blood sugar levels. SGLT2 inhibitors prevent glucose reabsorption in the kidneys, leading to glucose excretion in urine. These treatments are crucial for diabetes patients as they help maintain euglycemia, reducing the risk of complications and improving quality of life. Continuous glucose monitoring systems like the Eversense CGM provide real-time glucose data, enabling better management and timely adjustments to these therapies.

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