Trial results for a post-approval study of the Eversense® Continuous Glucose Monitoring (CGM) System in patients with diabetes were posted on ClinicalTrials.gov on 2025-06-12, with 273 participants enrolled.
Background
Diabetes Mellitus, encompassing both Type 1 and Type 2, is a chronic condition characterized by high blood glucose levels. Effective management is crucial to prevent complications, and continuous glucose monitoring (CGM) systems play a vital role by providing real-time glucose data. The Eversense® CGM System offers a long-term, implantable solution for glucose monitoring. This post-approval study aimed to evaluate its long-term safety and effectiveness over multiple insertion and removal cycles in a real-world setting, demonstrating its utility in ongoing diabetes management.
Trial design
This completed post-approval study, designated as Phase NA, enrolled 273 participants. The trial investigated the long-term safety and effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles. Participants included individuals with Diabetes Mellitus, specifically Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus. The study evaluated the performance of the Continuous Glucose Monitoring Device in a post-market setting.
Key results
The trial reported several key measurements related to the long-term safety and effectiveness of the Eversense® CGM System:
- The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting (Sensor cycle):
- 5 sensor cycles
- 24 sensor cycles
- 15 sensor cycles
- The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting (% time in range):
- Baseline Time in Range: mean of 62.9 (Standard Deviation 18.3)
- Baseline Time in Range: mean of 62.4 (Standard Deviation 20.1)
- The Additional Effectiveness Endpoint of Average Hours of Use Per Day (Daily use [hours]):
- Mean of 19 (Standard Deviation 7)
- The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline (percentage of HbA1c):
- Mean of 0 (Standard Deviation 0)
- Mean of -0.16 (Standard Deviation 1.04)
- Mean of -0.14 (Standard Deviation 0.96)
- Mean of -0.10 (Standard Deviation 0.96)
- Mean of 0.06 (Standard Deviation 1.31)
- Patient Satisfaction With CGM System Use (CGM-SAT Scale) (score on a scale):
- Mean of 4.0 (Standard Deviation 0.5)
What this means
The posted results from this post-approval study provide valuable insights into the real-world performance of the Eversense® Continuous Glucose Monitoring System. The data indicates long-term safety over multiple sensor cycles and demonstrates effectiveness through metrics such as average daily use of 19 hours. While changes in HbA1c levels varied across different 6-month intervals, showing small reductions or stability (e.g., a mean change of -0.16 percentage of HbA1c with a Standard Deviation of 1.04), baseline time in range was around 62.9%. Notably, patient satisfaction with CGM system use was high, with a mean score of 4.0 (Standard Deviation 0.5) on a satisfaction scale. These findings support the continued use and benefits of the Eversense® CGM System for individuals managing diabetes.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT03908125, titled "Post Approval Study of the Eversense® Continuous Glucose Monitoring", were posted on 2025-06-12 on clinicaltrials.gov.