The Connected in Motion (CIM) team was fortunate enough to participate in the 83rd Scientific Sessions of the American Diabetes Association, one of the world’s premier platforms dedicated to advancing diabetes research and care. We’re excited to share with you the insights and knowledge gained from these thought-provoking sessions. Our aim is to ensure that the diabetes community in Canada benefits from these global discussions, helping all of us better understand the disease, manage it more effectively, and enhance our overall health and quality of life.
In the world of diabetes management, continuous glucose monitoring (CGM) technologies have been revolutionary in helping individuals monitor their blood glucose levels more effectively. These devices provide real-time data and valuable insights into managing diabetes, offering a significant improvement over traditional fingerstick measurements. Recently, an exciting study concluded on a new implantable CGM that promises extended longevity and accuracy. Here are the details, presented by Lujain Al-Khawi, an algorithm development engineer at Senseonics, Inc.
The Study: Evaluating the Accuracy and Longevity of an Implantable CGM
The study focused on a feasibility assessment of an implantable CGM sensor over a period of 365 days. This innovative device, developed by Senseonics, is designed to address the limitations of transcutaneous CGM systems, which require frequent sensor insertions every 7 to 14 days.
Senseonics’ Eversense® E3 CGM system, approved by the FDA, has already set a new standard with its 180-day glucose sensing functionality. However, the goal of this study was to push the boundaries further and evaluate the potential for a 365-day implantable CGM system while maintaining accuracy and safety.
The Methodology: Assessing Longevity and Accuracy
The feasibility study involved 32 subjects who received the modified chemistry Eversense® E3 CGM sensor implant in their upper arm. These participants were instructed to take 4 to 7 blood glucose measurements per day using a glucose meter. Additionally, they were asked to visit the clinic monthly for safety inspections throughout the one-year study period.
The data collected from the experimental group, implanted with the modified CGM sensor, was compared to a subset of the PROMISE pivotal study (an evaluation of the Eversense® 180 CGM System), consisting of 30 subjects who extended their participation to 365 days. Both groups underwent the same algorithmic processing to evaluate accuracy over time.
Results: Promising Accuracy and Safety
The study revealed several promising findings. Firstly, the safety profile of the modified Eversense® E3 CGM system over the course of 365 days was similar to the PROMISE 180-day study. The only reported adverse events were minor skin irritations at the insertion site, which were quickly resolved.
Moreover, the sensor survivability of the modified CGM system was exceptionally high, with a 97% rate throughout the one-year period. This indicates that the implantable sensor was able to maintain its functionality for an extended period without significant issues.
Accuracy was a key focus of the study, and the results were highly encouraging. The modified CGM system showed no statistical difference in accuracy compared to the control group using the E3 CGM system for 180 days. The overall accuracy for the modified CGM system was 98%, indicating its ability to consistently provide reliable glucose measurements across all glycemic ranges.
Implications and Future Prospects
The implications of this study are immense for individuals living with diabetes. The extended longevity of the implantable CGM system offers the potential for improved convenience, reducing the need for frequent sensor insertions. Moreover, the promising accuracy results indicate that users can rely on this device for precise glucose monitoring throughout the year.
Senseonics aims to further improve the technology by reducing the calibration frequency while maintaining accuracy and longevity. This ongoing effort demonstrates a commitment to enhancing the user experience and making diabetes management more seamless and effective.
It is important to note that the modified Eversense® E3 CGM system is still undergoing further evaluation in an ongoing pivotal study, with the aim of submitting the data for FDA approval in the near future. This suggests that the implantable CGM system may soon become a reality, revolutionizing the way people manage their diabetes.
Conclusion
The recent study on the implantable continuous glucose monitor by Senseonics represents a significant advancement in diabetes management. With its potential for extended longevity, accuracy, and safety, this device offers a promising solution for individuals with diabetes. By reducing the burden of frequent sensor insertions and maintaining reliable glucose measurements over a year, the implantable CGM system could transform the lives of millions of people worldwide.
As the research progresses and the technology evolves, the future of glucose monitoring looks brighter than ever. Individuals with diabetes can look forward to a more streamlined and effective way of managing their condition, allowing them to live life to the fullest with confidence and peace of mind.
Disclaimer: The information presented in this article is for informational purposes only. It is important to consult with healthcare professionals for personalized advice and guidance regarding diabetes management.
