What side effects are associated with this type of intervention?

Common treatments for diabetes, such as insulin, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT2 inhibitors, have various side effects. Insulin therapy can cause hypoglycemia, weight gain, and injection site reactions. GLP-1 receptor agonists, like liraglutide and semaglutide, may lead to gastrointestinal issues such as nausea, vomiting, and diarrhea, and in some cases, pancreatitis. DPP-4 inhibitors are generally well-tolerated but can cause nasopharyngitis, headaches, and, rarely, pancreatitis. SGLT2 inhibitors, such as dapagliflozin, can lead to urinary tract infections, genital infections, and dehydration. Continuous glucose monitoring systems themselves are generally safe but can cause skin irritation at the sensor site.

What prior FDA approvals exist?

The FDA has approved several continuous glucose monitoring (CGM) systems for the management of diabetes, including the Eversense CGM System. These systems provide real-time glucose readings, helping patients manage their blood sugar levels more effectively. Other notable CGM systems include the Dexcom G6 and the FreeStyle Libre, which have also received FDA approval. These devices are part of a broader strategy to improve diabetes management through advanced monitoring technologies, complementing pharmacological treatments such as insulin and GLP-1 receptor agonists.

What other types of research exist?

Promising, novel alternatives to the Eversense 524 CGM System and ROME CGM System for diabetes patients in 2024 include the Dexcom G7 and Abbott's FreeStyle Libre 3. The Dexcom G7 offers improved accuracy, a smaller and more discreet sensor, and a simplified application process. Abbott's FreeStyle Libre 3 provides real-time glucose readings with a small, easy-to-apply sensor and has received positive feedback for its user-friendly interface and cost-effectiveness.

← Back to Search

Continuous Glucose Monitoring System

Continuous Glucose Monitoring for Diabetes

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

Subjects greater than or equal to18 years of age

Must not have

History of unexplained severe hypoglycemia in the previous 6 months. Severe hypoglycemia is defined as hypoglycemia resulting in loss of consciousness or seizure.

History of hepatitis B, hepatitis C, or HIV

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 365 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation where the device attaches, possible allergic reactions if sensitive to materials used in the CGM system components; discomfort during insertion/removal of sensors; risk of inaccurate glucose readings leading to mismanagement of insulin doses.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

I have had a severe low blood sugar episode that caused me to pass out or have a seizure in the last 6 months.

Select...

I have a history of hepatitis B, C, or HIV.

Select...

I have gastroparesis.

Select...

I have been hospitalized for diabetic ketoacidosis in the last 6 months.

Select...

I am currently on or might need immunosuppressants, chemotherapy, blood thinners (except aspirin), topical steroids, or long-term antibiotics.

Select...

I have a history of adrenal insufficiency.

Select...

I am not pregnant, breastfeeding, planning to become pregnant, or avoiding birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 365 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~365 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 365 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

Effectiveness Objective: To determine accuracy of the Eversense 524 CGM System and ROME CGM System.

Safety Objective: To demonstrate safety of the Eversense 524 CGM System and ROME CGM System.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Continuous Glucose Monitoring DeviceExperimental Treatment1 Intervention

Eversense 524 CGM System and ROME CGM System.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Continuous Glucose Monitoring System

2016

N/A

~550

0 / 8Eligibility 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

Continuous Glucose Monitoring (CGM) systems, such as the Eversense 524 CGM System and ROME CGM System, provide real-time tracking of glucose levels, allowing for better management of diabetes by alerting patients to hyperglycemia or hypoglycemia. This continuous feedback helps patients and healthcare providers make informed decisions about diet, exercise, and medication adjustments, leading to improved glycemic control. GLP-1 receptor agonists, like semaglutide and liraglutide, enhance insulin secretion, inhibit glucagon release, and slow gastric emptying, which helps lower blood glucose levels and supports weight loss. Insulin therapy involves administering insulin to regulate blood glucose levels, essential for patients with insufficient insulin production. These treatments are crucial as they help prevent complications associated with diabetes, such as cardiovascular disease, neuropathy, and kidney damage.

[Management of hyperglycemia in type 2 diabetes: a consensus algorithm for the initiation and adjustment of therapy. (A consensus statement from the American Diabetes Association and the European Association for the Study of Diabetes)].Is it worth treating gestational diabetes: if so, when and how?The use of continuous glucose monitoring in patients with type 2 diabetes.