The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time a day after day 21, and when symptoms do not match CGM information or when taking medications of the tetracycline class.
Full Answer
What is the Eversense® continuous glucose monitoring system?
The Eversense® continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal is pertormed by a health care provider.
What is Eversense CGM used for?
The Eversense CGM System is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days. It is designed to replace blood glucose testing for diabetes treatment decisions. The system is intended to: Provide real-time glucose readings.
What is the Eversense system?
So here are some short facts about the Eversense System: Implantable sensor Lasts up to 90 days (under the skin) Smartphone app with real-time tracking On-body vibration alerts (via the transmitter) when your blood sugar is low or high Chargeable, removable, water-resistant transmitter
How does the Eversense transmitter work?
The Transmitter is worn over the sensor and wirelessly powers it to activate the transfer of glucose measurements. After implanting the sensor, the transmitter starts receiving glucose data from it and calculates the glucose value, which is then sent to the Eversense App via Bluetooth.
What is a BG sensor?
Glucose sensors are biosensors designed to detect glucose levels, which is vital to managing diabetes.
What is a self monitoring glucose meter?
Self-Monitoring of Blood Glucose (SMBG) is an approach whereby people with diabetes measure their blood sugar (glycemia) themselves using a glycemic reader (glucose meter). Based on the reading, they can adjust or check the effect of their treatment (diet, exercise, insulin, antidiabetics, stress management).
Do you need to calibrate Eversense?
The sensor requires two calibrations per day for the first 21 days of wear. After day 21, one fingerstick calibration is required each day (an improvement over the 90-day sensor which requires two calibrations per day for the entire 90 days).
Does Eversense CGM require calibration?
With the Eversense System, there are two phases: Initialization Phase during which 4 fingerstick tests are required, and the Daily Calibration Phase, during which 1 fingerstick test is required twice daily. CGM Continuous Glucose Monitoring.
How do you use a self-monitoring blood glucose meter?
1:513:05TRUE METRIX Self Monitoring Blood Glucose Meter - YouTubeYouTubeStart of suggested clipEnd of suggested clipAnd hold it there until the meter beeps dashes will appear across the display to indicate that theMoreAnd hold it there until the meter beeps dashes will appear across the display to indicate that the meter is testing. In as fast as four seconds your blood glucose result is displayed in the meter.
How do you use a self glucose meter?
3:163:52How to Use Glucometer at Home? Test Your Blood Sugar LevelYouTubeStart of suggested clipEnd of suggested clipOne step is to first insert the glucometer strip into the small socket that is there in theMoreOne step is to first insert the glucometer strip into the small socket that is there in the glucometer. Here. Second is to use the lancing device for a prick and get the capillary blood sample.
How accurate is Eversense?
The Eversense CGM system measures glucose every 5 min through a fluorescent-based optical methodology with the glucose information sent directly to a Mobile Medical Application (MMA) app on the smartphone. The system has high accuracy with a mean absolute relative difference (MARD) of 8.5%.
Is Eversense better than dexcom?
Researchers found the Senseonics Eversense implantable CGM to be more accurate than the Dexcom G5 and the Abbott Freestyle Libre Pro, the professional version of the CGM, devices.
Is Eversense a professional CGM?
The Eversense Data Management System (DMS) Pro is a web-based application for healthcare professionals to manage and review glucose data of their patients that use the Eversense CGM System.
How much does Eversense cost?
Eversense pricing They typically run between $200 to $300 for insertion and $300 to $400 for removal and reinsertion. But even with that, the annual cost of use — before insurance is factored in — is close to that of the competing Dexcom CGM. Estimated total: $6,400 per year, or $533 a month.
How long does the Eversense transmitter last?
Eversense Smart Transmitter It wirelessly sends glucose data (via Bluetooth) to the mobile device app. The smart transmitter also provides on-body vibe alerts based on the pre-set glucose level settings. It has a rechargeable battery and is reusable for up to one year.
Does Eversense work with an insulin pump?
Although Eversense does not currently pair with an insulin pump, hybrid and closed loop pairing are on the horizon along with longer sensor wear and less calibrations.
What is the main disadvantage of using a glucometer?
It can Lead to Skin Changes People with diabetes need to monitor their blood glucose level regularly and that is why they prick daily or even more than once a day. This constant pricking at a site can cause skin changes.
When should you self monitor blood sugar?
Most experts agree that insulin-treated patients should monitor blood glucose at least four times a day, most commonly fasting, before meals, and before bed.
What is the normal sugar level in blood?
A blood sugar level less than 140 mg/dL (7.8 mmol/L) is normal. A reading of more than 200 mg/dL (11.1 mmol/L) after two hours indicates diabetes. A reading between 140 and 199 mg/dL (7.8 mmol/L and 11.0 mmol/L) indicates prediabetes.
How do I check my own blood sugar levels?
How do I check?After washing your hands, insert a test strip into your meter.Use your lancing device on the side of your fingertip to get a drop of blood.Touch and hold the edge of the test strip to the drop of blood and wait for the result.Your blood glucose level will appear on the meter's display.
How to contact Eversense customer support?
For additional Eversense product questions and troubleshooting issues, contact Customer Support toll free in the US at 844-SENSE 4U (844-736-7348).
Can you use diathermy on a sensor?
Diathermy – DO NOT use diathermy on people who have an inserted sensor. Energy from the diathermy can transfer through the sensor and cause tissue damage in the insertion area. Electrocautery – The use of electrocautery near the inserted sensor may damage the device. DO NOT use electrocautery near the sensor.
Can Eversense be used on jailbroken iPhone?
DO NOT use the Eversense apps on jailbroken iPhones or iPods. Jailbroken devices do not provide an acceptable level of security and accuracy for the user and are not approved for use by Senseonics.
Can you wear a smart transmitter for MRI?
The smart transmitter is incompatible with magnetic resonance imaging (MRI) procedures. Patients should not undergo an MRI procedure when wearing the smart transmitter. For information on the sensor, please see MRI Safety Information.
Can you use a smart transmitter with a blood glucose meter?
Always test your glucose with your blood glucose meter before making a treatment decision. If your smart transmitter is damaged or cracked, DO NOT use, as this could create an electrical safety hazard or malfunction, and could result in electrical shock.
Can a smart transmitter give you glucose alerts?
If the system cannot display a glucose value, it also cannot provide glucose alerts. If you are unable to feel the vibration of the smart transmitter you may not notice the alerts. The system’s calculated glucose can be slightly different from your blood glucose meter.
My Second Insertion
In early March, I went back to my doctor’s office to have the Eversense sensor removed from my left shoulder, and a new one inserted in the right.
Glooko-Eversense Integration
Have you heard that the Eversense folks have announced integration with the Glooko D-data platform? This means if you download the Glooko app on your phone, you can now simply choose the “Eversense” icon to link to your live sensor, where you can view 1-week, 2-week, 1-month and 3-month data sets.
Dr. Fran Kaufman Joins Eversense
Kudos to the company behind Eversense, Maryland-based Sensionics, for nabbing probably the most sought-after Chief Medical Officer in the diabetes world: Dr. Fran Kaufman, who “retired” as CMO of Medtronic just three months ago in December 2018.
Eversense Clinical Trials & Expanding Use
Eversense has several studies underway in Europe currently, and in the U.S. is recruiting patients for its PROMISE pivotal study that will gather evidence for 180-day use approval (as opposed the current 90 days). Trial sites are in California, Georgia, Texas and Washington state.
What is the purpose of Eversense CGM?
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.
How long does Eversense monitor glucose?
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.
How long does a glucose sensor last?
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.
What is the purpose of blood glucose monitoring?
Additionally, monitoring may help delay or prevent diabetes complications such as heart attack, stroke, kidney disease, blindness, and amputation. 2-4
How often do you need to monitor glucose levels?
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.
How long does EverSense last?
So here are some short facts about the Eversense System: Implantable sensor. Lasts up to 90 days (under the skin) – it’s approved for 180 days in Europe. Smartphone app with real-time tracking. On-body vibration alerts (via the transmitter) when your blood sugar is low or high.
How does the EverSense transmitter work?
The Transmitter is worn over the sensor and wirelessly powers it to activate the transfer of glucose measurements. After implanting the sensor, the transmitter starts receiving glucose data from it and calculates the glucose value, which is then sent to the Eversense App via Bluetooth.
What is the Eversense system?
For those who may be unfamiliar, or need a reminder, the Eversense system from Maryland-based Senseonics is the world’s first long-term implantable CGM. It consists of a tiny sensor the size of a small twig that is implanted underneath the skin in the upper arm for 90-day wear (approved for 180 day-wear in Europe);
How long does it take for Eversense to sync?
Eversense needs 15 minutes to sync after each calibration, so do not remove the transmitter for charging during this time!
How long does it take for a ringer to snooze?
This option makes it so you only get sound alerts if you ignore the transmitter vibration for a High or Low “snooze” period that you choose yourself, from 5 to 30 minutes.
How long is a syringe good for?
In the US, the sensor is approved for 3 months of continuous use, and the European version (scheduled to hit the US market in the next year or two) is good for 6 months. What this means is that there are no “warmup” times other than the day the sensor is first inserted.
How often do you have to do a fingerstick calibration?
It’s not a painful experience (numbing agents are used), but it is inconvenient and leaves a small scar. And it has to be repeated every three months. > The system requires fingerstick calibrations at least twice daily, and the calibrations can only be performed when the glucose is in a steady-state.
Does Eversense have medical coverage?
The No’s: > In many instances, there is no medical coverage for Eversense. Senseonics is working on this, but they still lack the (near) universal coverage of other CGM systems. Discounts are available for those who lack insurance coverage. The system is not yet approved for use among children.