US Pharm. 2020;45(9):
Diabetes mellitus (DM) is a group of metabolic disorders characterized by a deficiency in physiological glucose control. The etiology of DM is traditionally attributed to defects in insulin secretion, sensitivity, or both. According to the American Diabetes Association, diabetes may be categorized into two major classes: type 1 and type 2. In type 1, absolute beta-cell destruction is remarkable, whereas a progressive loss of beta-cell function is seen in type 2. When left untreated, complications of DM may result in hyperglycemic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, and severe hypoglycemia.1
The 2020 National Diabetes Statistics Report, developed by the CDC, reported that a total of 34.2 million people have been diagnosed with diabetes in the United States (10.5% of the population). Of those reported, 7.3 million people who met laboratory criteria for diabetes were not aware of or did not report having diabetes. Among adults aged 18 years and older in the U.S., prevalence of diabetes was highest among American Indians/Alaska Natives (14.7%), Hispanics (12.5%), non-Hispanic blacks (11.7%), non-Hispanic Asians (9.2%), and non-Hispanic whites (7.5%).1
MonitoringBlood glucose monitoring is the primary tool for managing type 1 or type 2 diabetes. Results from blood glucose monitoring can assist in healthier lifestyle choices (e.g., food, physical activity), medication compliance, and a reduction in adverse events. Additionally, monitoring may help delay or prevent diabetes complications such as heart attack, stroke, kidney disease, blindness, and amputation.2-4
Continuous glucose monitoring (CGM) is one method to track glucose levels throughout the day and night. CGM systems deliver real-time glucose measurements at regular intervals, every 5 to 15 minutes, 24 hours a day, and translate the readings into data. Having this information helps CGM users proactively manage glucose fluctuations throughout the week. It also provides additional insight for practitioners on the impact of nutrition, physical activity, medication management, and illness on daily glucose levels.1,2,5,6
Device Description and Design
The Eversense CGM System is a prescription device that produces real-time glucose monitoring every 5 minutes for up to 90 days at a time and alerts for detection and prediction of hypoglycemia and hyperglycemia. This system is helpful for monitoring glucose levels in those who use insulin (type 2) and who have consistent instabilities with glucose levels in type 1 patients.5 Diabetics can use this device to manage negative glucose patterns and make long-term adjustments to treatment plans.5 It is indicated for continually measuring glucose levels in adults aged 18 years and older with type 1 or type 2 diabetes.
The monitor consists of an implantable fluorescence-based sensor, a removable and rechargeable smart transmitter, and a convenient mobile app for displaying real-time monitoring and management. Sensor insertion (upper arm under the skin) and removal procedures should be performed by a healthcare provider. A fluorescent chemical coating on the outside of the sensor generates a small amount of light in response to the amount of glucose present in fluid under the skin (interstitial glucose) for up to 90 days. The removable smart transmitter is worn externally over the sensor. The light signal captured from the sensor by the transmitter is subsequently converted into a glucose reading and transmitted wirelessly to a compatible mobile device (e.g., phone, tablet) every 5 minutes. The Eversense app will alert the user of low or high sensor glucose values based on alert settings. Subtle vibrations can be felt in the arm when glucose levels have altered.5,6
Compared with other CGM systems, Eversense provides long-term wear, as sensors only have to be changed four times a year. Additionally, Eversense is the only CGM with on-body vibrations to alert users of glucose fluctuations, which is beneficial when sleeping, driving, or when otherwise unable to check mobile app devices. The components of the Eversense CGM, as well as an example reading and insertion, are shown in FIGURES 1–3.5
Two nonrandomized, prospective, single-arm, multicenter studies were performed by Senseonics to assess the safety and efficacy of the Eversense CGM System. The PRECISE II study (blinded) consisted of 90 diabetic patients, and the PRECISION study (unblinded) consisted of 35 subjects. Both studies were conducted in the U.S.
Precise II Study
The accuracy of the system was evaluated during clinic visits by comparing sensor to laboratory values drawn every 5 to 15 minutes. Sessions consisted of upper-arm exercises for a duration of 30 minutes and were performed on days 1, 30, 60, and 90 for a period of 4.5 to 12.5 hours. Throughout the course of the study, 97 out of 106 sensors remained functional for the full 90 days. Overall, 93% of CGM values were within 20% of the reference values over the total glucose range of 40 mg/dL to 400 mg/dL.7 In the Precise II study, users reported a high level of satisfaction and reduced distress.
The PRECISION study was conducted to further evaluate the efficacy of the device, with emphasis on early sensor life. Thirty-five adult subjects participated in this study: 27 had a sensor placed in both arms, and the remaining eight subjects received a single sensor. During days 1, 7, and 14, visits spanned 2 days to collect more data, and on days 30, 60, and 90, the visits were only 1 day. Mean hemoglobin A1C levels were 7.8% at the beginning of the study and declined to 7.5% by the conclusion. Eighty-five percent of CGM values were within 15% of reference, indicating a clinically accurate range. All sensors were functional throughout the duration of the study.8
While monitoring glucose levels daily can be challenging, the Eversense CGM System offers a convenient way to manage levels throughout the day. The device was shown to enrich patient lives by producing excellent adherence and outcomes. Though efficacy is similar to other devices on the market, Eversense is unique as it provides long-term monitoring for up to 90 days in real time to accurately manage diabetes. For more information on Eversense CGM, visit www.fda.gov/medical-devices/recently-approved-devices/eversense-continuous-glucose-monitoring-system-p160048s006.
The content contained in this article is for informational purposes only. The content is not intended to be a substitute for professional advice. Reliance on any information provided in this article is solely at your own risk.
1. American Diabetes Association: Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2019. Diabetes Care. 2019;42(Suppl1):S13-S28.
2. CDC. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Department of Health and Human Services; 2020. www.cdc.gov/diabetes/data/statistics/statistics-report.html. Accessed June 1, 2020.
3. National Institute of Diabetes and Digestive and Kidney Diseases. Symptoms & causes of diabetes. 2020. www.niddk.nih.gov/health-information/diabetes/overview/symptoms-causes. Accessed June 1, 2020.
4. National Institute of Diabetes and Digestive and Kidney Diseases. Managing diabetes. 2020. www.niddk.nih.gov/health-information/diabetes/overview/managing-diabetes. Accessed June 1, 2020.
5. FDA. Eversense Continuous Glucose Monitoring System. 2020. www.fda.gov/medical-devices/recently-approved-devices/eversense-continuous-glucose-monitoring-system-p160048s006. Accessed June 2, 2020.
6. Eversense Continuous Glucose Monitoring System. Eversensediabetes.com. 2020. Accessed June 2, 2020.
7. Christiansen MP, Klaff LJ, Brazg R, et al. A prospective multicenter evaluation of the accuracy of a novel implanted continuous glucose sensor: PRECISE II. Diabetes Technology & Therapeutics. 2018;20(3):197-206.
8. Christiansen MP, Klaff LJ, Bailey TS, et al. A prospective multicenter evaluation of the accuracy and safety of an implanted continuous glucose sensor: the PRECISION study. Diabetes Technology & Therapeutics. 2019;21(5):231-237.
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