Senseonics’ Eversense: 90-day Implanted CGM Enters US Pivotal Trial

Clinical Trials Identifier: NCT02647905

Trial Name: Evaluation of the Accuracy of an Implanted Glucose Sensor (PRECISE II)

Diabetes Type: Type 1 and Type 2 Diabetes

What it’s testing: This pivotal trial will evaluate the accuracy and safety of the Senseonics’ implantable, 90-day Eversense CGM system. Eversense CGM measurements will be compared to a laboratory reference device at several in-clinic visits over the 90-day wear period.

Why is this new/important: Current CGM offerings (Medtronic and Dexcom) in the US involve a sensor inserted through the skin and a transmitter that is attached externally to the body; these sensors last only seven days before they need to be replaced (though some people wear them slightly longer). Eversense uses a longer-term, 90-day implanted sensor, which is placed in the upper arm in a simple 5-10 minute in-office procedure. Since the sensor doesn’t contain a battery, a transmitter device is worn externally over the sensor to power the sensor and send the data to a smartphone. Both the smartphone and transmitter will alert the user of a high or low.  Even if the phone is out of range, the transmitter will provide on-body vibe alert to indicate a high or low. Senseonics has completed a pivotal trial in Europe, where Eversense is still awaiting approval. If this new US trial finds the Eversense system is safe and effective, it opens the door for a US FDA submission.

Trial Length: 90 days.

Trial Location(s): The trial is currently recruiting at Diablo Clinical Research, Walnut Creek, California; Rainier Clinical Research, Renton, WA; John Muir Physician Clinical Research Center, Concord, CA; AMCR Institute, Escondido, CA; Clinical Trials of Texas, San Antonio, TX; Worldwide Clinical Trials, San Antonio, TX; Atlanta Diabetes Associates, Atlanta, GA; UVA Diabetes and Endocrine Clinic, Charlottesville, VA; and Mount Sinai Diabetes Center, New York, NY.

Do you qualify?

• Age 18 or older
• Diagnosed with diabetes (type 1 or type 2) for at least one year

Exclusion criteria include:

• History of severe hypoglycemia in the past six months
• History of diabetic ketoacidosis requiring ER visit or hospitalization in the past six months
• Women who are pregnant, plan to become pregnant, or who are not taking birth control during the course of the study
• History of hepatitis B, hepatitis C, or HIV

For a full list of the trial’s inclusion criteria, please visit its webpage here.

Where to get more information: For more information about the trial, please contact Emily Gades at 925-930-7267 or egades@diabloclinical.com, or see the trial’s webpage here. -AJW/AB