PROMISE Study Provides Insight into Safety, Accuracy of Eversense 180-Day CGM System

Data from the PROMISE Study is providing clinicians with insight into the accuracy and safety of the Eversense 180-day continuous glucose monitoring system.

With the Eversense E3 CGM system approved by the US FDA on February 11, data from the study provide an overview of the safety and accuracy of the system, which could help guide treatment for patients with diabetes.

“The PROMISE study, evaluating the next-generation long-term implantable Eversense CGM system, showed that both the primary and SBA sensors were safe and accurate lasting up to 180 days,” wrote investigators.

A prospective, multicenter, unblinded, nonrandomized study enrolling patients with type 1 and type 2 diabetes from 8 medical centers in the US, PROMISE was designed with the aim of was designed to assess the safety and accuracy. Conducted between December 27, 2018, and May 08, 2020, the trial assessed the accuracy of the Eversense CGM system over 180 days through a comparison against the accuracy of the Yellow Springs Instrument 2300 glucose analyzer from 10 clinic visits conducted during the study period.

A total of 208 individuals were enrolled in the trial and 181 were ultimately injected with a primary sensor. A cohort of 96 individuals had a second sensor inserted, either an identical sensor or a modified sacrificial boronic acid (SBA) sensor, in their other arm. Of these 96, 53 received an identical sensor and 43 received a modified SBA sensor. Other outcomes of interest for the study included confirmed event detection rates, calibration stability, sensor survival, and serious adverse events.

The 181-patient cohort ad a mean age of 48.6 (SD, 14.9) years, 47% were male, 90.1% were Caucasian, and the mean years since diabetes diagnosis was 22.0 (SD, 13.3) years. The majority of patients (69.6%) had type 1 diabetes.

Upon analysis, results indicated the percent CGM readings within 20%/20% of Yellow Springs Instrument values was 92.9% for primary sensors (MARD, 9.1%). Confirmed alert detection rates for the alert settings of 60 and 70 mg/dL were 87% and 93%, respectively, and 99% and 98% at 180 and 240 mg/dL, respectively. When assessing accuracy of the SBA sensors, results suggested the percent CGM readings within 20%/20% of Yellow Springs Instrument values was 93.9% (MARD, 8.5%). Confirmed alert detection rates for the alert settings of 60 and 70 mg/dL were 90% and 94%, respectively, and 99% and 98% at 180 and 240 mg/dL, respectively.

Investigators noted the median percentage of time for one calibration per day was 63% and 90% of SBA sensors survived to 180 days. Additionally, investigators pointed out there were no device insertion or removal procedure-related serious adverse events reported in the trial.

“The data from the PROMISE study support the next-generation Eversense CGM system, with reduced calibration enabling a single calibration point to be entered on about half of the days of system wear,” wrote investigators.

This study, “Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study,” was published in Diabetes Technology & Therapeutics.