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: Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System
PMA Applicant: Dexcom, Inc.
Address: 6340 Sequence Drive, San Diego, CA 92121
Approval Date: February 3, 2014
Approval Letter: http://www.accessdata.fda.gov/ cdrh_docs/pdf12/P120005S002a.pdf
What is it? The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System (Pediatric CGM System) is an externally-worn glucose sensor that continuously measures and displays glucose values. In addition to reporting glucose values every 5 minutes, the system reports trending information in real-time for up to seven days (the life of each sensor).
How does it work? The Pediatric CGM System includes several components: a sensor, transmitter and receiver. The glucose sensor contains a wire that is inserted under the skin on the abdomen or upper buttock and measures glucose values in the fluid around the cells (interstitial fluid). The glucose values are sent through the transmitter to the hand-held receiver, where they are displayed for the user.
When is it used? The Pediatric CGM System is a glucose monitoring device used (indicated) for detecting trends and tracking patterns in children ages 2 to 17 with diabetes. The approval of this device expands the intended user population, first approved for use in patients 18 years and older (P120005).
The Pediatric CGM System is intended for single patient use and requires a prescription. The Pediatric CGM System is indicated to complement, not replace, information obtained from standard home glucose monitoring devices.
The Pediatric CGM System aids in the detection of episodes of high glucose levels (hyperglycemia) and low glucose levels (hypoglycemia), helping with both short- and long-term therapy adjustments, which may lessen these extreme episodes. Interpreting the Pediatric CGM System results should be based on the trends and patterns seen with several consecutive readings over time.
The pediatric clinical study demonstrated that the Pediatric CGM System’s performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the hypoglycemic detection alert in the pediatric clinical study was not as accurate to that seen in the adult study, especially at blood glucose concentrations below 70 milligrams per deciliter. However, despite the reduced accuracy in this patient population, this device can provide valuable glucose tracking and trending information to children with diabetes and their families provided they understand the expected performance of this device.
To communicate the reduced accuracy in performance to users, the following warnings are displayed in the labeling and are displayed on the receiver screen when a new sensor session is started or when the alert thresholds are changed:
- In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared to those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.
- In a pediatric clinical study, a significant number of low glucose events were not detected by the CGM. Do not rely solely on CGM alerts to detect low blood glucose.
What will it accomplish? Children with diabetes and their families can use the tracking and trending glucose information to help them understand the patterns in their glucose levels. They can be alerted when glucose values are approaching dangerously high and dangerously low levels. When used along with a blood glucose meter to obtain a more accurate reading of actual blood glucose levels, the Pediatric CGM System can also help people with diabetes make long-term adjustments to their treatment plan to keep blood glucose levels in a safe range.
When should it not be used?
- Remove the Dexcom G4 PLATINUM sensor, transmitter, and receiver before Magnetic Resonance Imaging (MRI), Computed Tomography (CT) scan, or diathermy treatment. The Dexcom G4 PLATINUM (Pediatric) System has not been tested during MRI or CT scans or with diathermy treatment. The magnetic fields and heat could damage the device so that it might not display sensor glucose readings or provide alerts, and you might miss a low or high blood glucose value.
- Taking medications with acetaminophen (such as Tylenol) while wearing the sensor may falsely raise your sensor glucose readings. The level of inaccuracy depends on the amount of acetaminophen active in your body and may be different for each person.
Additional information: The Summary of Safety and Effectiveness Data and labeling are available online.