Children as young as 2 years old can now use the latest in diabetes med tech, even as the company that developed it is in a race to surpass its most current technology. The
FDA announced Monday it has approved a pediatric version of DexCom’s ($DXCM) G4 Platinum. The San Diego med tech now has the first continuous glucose monitor (CGM) approved in the U.S. for toddlers.
The G4 Platinum is among a generation of slim, small CGMs that wirelessly report glucose levels every few minutes. The pediatric designation puts DexCom among the relatively few companies that have developed medical devices for children.
It’s a market the FDA views as neglected. Last September, the regulatory agency flagged pediatric devices as a priority, setting aside $3.5 million for research and academic-industry partnerships in pediatric-friendly devices that address unmet needs.
DexCom isn’t the only diabetes-focused company working on child-friendly devices. Its pediatric CGM could be peanut butter to Novo Nordisk’s jelly. The Danish drugmaker ($NVO) is set to hit the U.S. market in early 2014 with its NovoPen Echo, a child-friendly insulin pen approved last August.
Meanwhile, the company is racing to get beyond glucose monitoring. Paired with J&J’s Animas unit ($JNJ), DexCom is vying with Medtronic ($MDT) and upstart Tandem to be first to develop the next generation of diabetes devices–a closed-loop insulin pump. Also known as an artificial pancreas, the devices would detect blood glucose content and respond automatically. It’s a long-standing goal. If reached, it would be a major improvement over the current generation of CGMs.
From www.fiercemedicaldevices.com
Press release från företaget
Innovative Dexcom G4® PLATINUM Continuous Glucose Monitor (CGM) Receives FDA Approval for Use in Children Ages 2 to 17 Years
Now Children Can Gain Better Control of Their Diabetes with Advanced CGM Technology
Dexcom, Inc., (NASDAQ:DXCM), the leader in continuous glucose monitoring (CGM), announced today that it has received U.S. Food and Drug Administration (FDA) approval for its CGM device: Dexcom G4® PLATINUM (Pediatric) for use in children ages 2 to 17 years with diabetes. Already approved for adults 18 and older, the Dexcom G4 PLATINUM (Pediatric) is now the only CGM system approved for children as young as two years old.
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years.
The traditional standard-of-care for blood glucose measurement has been a blood glucose meter. CGM is important because it can help educate kids on how to best learn to manage their diabetes into adulthood.
”We are thrilled with the FDA’s approval of our Dexcom G4 PLATINUM System in the pediatric population,” said Terrance H. Gregg, CEO of Dexcom. ”Daily management is relentless, and parents can now have greater peace of mind that a child’s diabetes is under control, whether the child is at home, away at school, or participating in activities or sports.
The Dexcom G4 PLATINUM provides dynamic glucose information harnessing today’s most innovative technology, so that persons with diabetes can go about their daily lives without added worry.”
Diabetes affects 25.8 million Americans and is the seventh leading cause of death in the United States.With diabetes, the body can’t produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. There are two types of diabetes – type 1 and type 2. Type 1 is more common in children and young adults. People with this form of diabetes require insulin to survive and frequent monitoring of their blood glucose levels.
The Dexcom G4 PLATINUM tracks glucose levels continuously for 7 days throughout the 24-hour period using wireless technology, enabling users to view their glucose levels on demand. The system allows persons with diabetes to program personalized information, such as glucose targets and alerts, and it has an alarm feature to alert the user if glucose levels rise or fall to dangerous levels. This is important as uncontrolled glucose can cause health complications and even death.The Dexcom G4 PLATINUM is the only CGM that comes with a built-in alarm that notifies users when glucose levels fall to critically low levels for an additional level of awareness no other CGM brand offers.
While the Dexcom G4 PLATINUM is now approved for children ages 2-17 years, what is significant is the indication for young children ages 2-6 years, making the Dexcom G4 PLATINUM (Pediatric) the first CGM device approved for persons with diabetes in this age-range and the only CGM device that offers an alternate sensor wear site on the upper buttocks for added flexibility.
”Continuous glucose monitoring offers a unique opportunity for patients with diabetes to safely aim for glucose levels close to the reference range found in persons without diabetes,” said Lori Laffel, MD, M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, in Boston, MA. ”Glucose levels can change without warning; this device gives the user and their loved ones more dynamic information for optimal diabetes control, and it’s extremely user-friendly.”
The Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (ages 2 to 17 years) with diabetes. CONTRAINDICATIONS: Remove the System before MRI, CT scan, or diathermy treatment. Taking acetaminophen while wearing the sensor may falsely raise your sensor glucose readings. WARNING: Do not use the System for treatment decisions. The System does not replace a blood glucose meter. 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 CGM. Do not rely solely on CGM alerts to detect low glucose. If a sensor breaks and no portion of it is visible above the skin, do not attempt to remove it. Seek professional medical help if you have infection or inflammation. Report broken sensors to Dexcom Technical Support. The System is not approved for use in pregnant women or persons on dialysis. Sensor placement is not approved for sites other than under the skin of the belly or upper buttocks.
1. Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. . 2012;(3)2:83-93.
2. Centers for Disease Control and Prevention, 2011 National Diabetes Fact Sheet
3. National Diabetes Information Clearinghouse, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Diabetes Overview
4. American Diabetes Association ()
5. Dexcom G4 PLATINUM (Pediatric) User Guide, 2013
Från FDA press release
FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system
February 4, 2014
FDA approves pediatric use of Dexcom’s G4 Platinum continuous glucose monitoring system
The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
Diabetes is a serious, chronic metabolic condition in which the body is unable to adequately manage blood sugar levels. An estimated 25.8 million people – about 215,000 of them under age 20 – in the United States have diabetes.
If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.
A continuous glucose monitor (CGM) is a device that includes a small wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid). When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The FDA has not approved the use of CGM values alone to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions such as insulin dosing should be based on readings from a blood glucose meter.
The G4 Platinum System is an externally worn system that continuously displays an estimate of blood glucose levels and the direction and rate of change of these estimates. The device is intended to be worn by a single patient for up to seven days. It requires a prescription and is meant to complement, not replace, information obtained from standard home glucose monitoring devices.
The previously approved G4 Platinum System is for insertion of the sensor in the abdomen only. The new G4 Platinum (Pediatric) System, the first approved CGM system for use in patients 2 to 17 years of age, includes the upper buttock in addition to the abdomen as sensor insertion sites. The device system components (sensor and transmitter) are unmodified from the previous system.
”This device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients,” said Alberto Gutierrez, Ph.D., director, Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health. ”This approval for expanded use is part of the FDA’s work to meet the needs of children living with diabetes.”
Before the approval, the FDA reviewed data from a pivotal clinical study of in-clinic and home-use patients to assess the accuracy and precision of the system. One hundred and seventy-six patients ages 2 to 17 wore the G4 Platinum (Pediatric) sensor for seven days (168 hours). The accuracy of the system’s glucose readings was evaluated by comparing them to a clinical laboratory reference method (for patients ages 6 to 17) and to results obtained from finger stick samples on a blood glucose meter (for patients ages 2 to 17).
The pivotal clinical study demonstrated that the G4 Platinum (Pediatric) System performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the performance of the hypoglycemic detection alert in the pediatric study was poor relative to that seen in the adult study, particularly at blood glucose concentrations below 70 milligrams per deciliter of blood. Despite these limitations, the study did demonstrate that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.
To communicate the reduced accuracy in pediatric patients to users, two warnings are included in the labeling, and are displayed on the receiver screen when a new sensor session is started or 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 CGM. Do not rely solely on CGM alerts to detect low glucose.
• Research on CGMs is underway as part of a developmental artificial pancreas device system (APDS) for people with type 1 diabetes, a device that includes a CGM and an insulin pump. An artificial pancreas system would monitor glucose levels and automatically pump the appropriate amount of insulin as determined by a computer algorithm.
The G4 Platinum (Pediatric) System is manufactured by Dexcom, Inc., located in San Diego, Calif.
For more information:
FDA: Diabetes Information
FDA: Medical Devices
FDA: CDRH Office of In Vitro Diagnostic Device Evaluation and Safety
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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