Simplera system - P160007/S047
This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Simplera system
PMA Applicant: Medtronic MiniMed, Inc.
Address: 18000 Devonshire Street, Northridge, CA 91325
Approval Date: July 24, 2024
Approval Letter: Approval Order
What is it?
The Simplera system is a continuous glucose monitoring system that provides real-time blood sugar (glucose) values and trends through the Simplera app, which is installed on a compatible smart device such as a tablet or smartphone. Users can watch trends and track patterns in glucose levels. The system is designed to replace fingerstick blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
The Simplera system includes a sensor and an app, which work together to provide real-time glucose values and alerts to help users make diabetes management decisions. The Simplera sensor monitors glucose levels in the fluid between cells (interstitial fluid) of the arm and then wirelessly transmits these values to the app. The Simplera app runs on compatible devices such as a smartphone or tablet. It presents glucose values and trend information on the compatible device and alerts the user to low and high sensor glucose values based on pre-selected alert settings programmed by the user. Users can also manually enter information such as blood glucose measurements, meals or exercise, or insulin dosing using the app. The mobile device must be on and fully operational with Bluetooth and app notifications enabled for Simplera to function properly.
The Simplera system is a real-time continuous glucose monitoring system indicated for managing diabetes for people ages 18 and older. It is intended for use in home environments.
The Simplera app and sensor are intended to be used only by people who have a compatible mobile device and operating system, and who have enough experience to adjust mobile device settings as needed. The system communicates with connected devices to track trends in glucose levels and detect any low (hypoglycemia) and high (hyperglycemia) blood sugar occurrences. This information can help users with current and long-term treatment decisions. Interpreting Simplera system results should be based on glucose trends and several sensor readings in a row over time.
The Simplera system provides information that is used for diabetes management but does not provide any direct treatments. Low and high glucose alerts from the app and sensor may allow the user to take actions that prevent or lower episodes of hypoglycemia and hyperglycemia. The system can also help people with diabetes make long-term adjustments to their treatment plans to try and keep blood glucose levels in a safe range.
The Simplera system should not be used in people:
- Who are unwilling or unable to perform blood glucose tests as required.
- Who are unwilling or unable to maintain contact with their health care professional.
- Whose vision and hearing do not allow them to recognize alerts sent by the app.
Also:
- Do not use Simplera system readings to make treatment decisions during the first 12 hours of wearing a sensor. Use a blood glucose meter reading to make treatment decisions when the "Check BG" icon is shown during the first 12 hours.
- Consult a health care professional before using sensor glucose values to make treatment decisions (such as administering insulin) if taking a medication containing acetaminophen or paracetamol, such as cold medicines or fever reducers. These medications can falsely raise sensor glucose readings, leading to the administration of too much insulin and hypoglycemia. Do not use continuous glucose monitoring when taking hydroxyurea, also known as hydroxycarbamide. Taking hydroxyurea while using continuous glucose monitoring can result in much higher sensor glucose readings than actual blood glucose readings.
- Do not expose the Simplera sensor to magnetic resonance imaging (MRI) equipment, radio or sound wave (diathermy) therapy devices, or any other devices that generate strong magnetic fields such as CT scan or other types of radiation. Exposure to strong magnetic fields can cause the sensor to malfunction, result in serious injury, or be unsafe.