Dexcom G6 Integrated Continuous Glucose Monitoring System (iCGM)
INDICATION FOR USE: Real time, continuous glucose monitoring device indicated for the management of diabetes in persons age 2 years and older.
The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 System results should be based on the glucose trends and several sequential readings over time. The Dexcom G6 System also aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
The Dexcom G6 System is also intended to autonomously communicate with digitally connected devices, including automated insulin dosing (AID) systems. The Dexcom G6 System can be used alone or in conjunction with these digitally connected medical devices for the purpose of managing diabetes
ADDRESSING UNMET NEED:
- First type of CGM to be used as part of an integrated system with other compatible medical devices and electronic interfaces, which may include automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management
- Enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible.
- Patch device applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid
- Device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone
- Will trigger an alarm when a patient’s blood sugar enters a danger zone soaring too high or dropping too low
- If integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump
- Patch device should be replaced every 10 days
GENERIC DEVICE TYPE: Integrated continuous glucose monitoring system.
Intended to automatically measure glucose in bodily fluids continuously or frequently for a specified period of time. iCGM systems are designed to reliably and securely transmit glucose measurement data to digitally connected devices, including automated insulin dosing systems, and are intended to be used alone or in conjunction with these digitally connected medical devices for the purpose of managing a disease or condition related to glycemic control.
EFFECTIVENESS AND SAFETY:
- Two clinical studies, n=324 adults and children aged 2 years and older with diabetes, multiple clinical visits within a 10-day period where system readings were compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported during the studies.
- Risks may include hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar), skin irritation or redness around the device’s adhesive patch
IDENTIFIED RISKS AND MITIGATIONS:
- Clinical action based on falsely high or falsely low inaccurate glucose values or inaccurate alerts may lead to inappropriate treatment decisions: General and Special Controls
- Clinical action in pediatric patients based on falsely high or falsely low inaccurate values or inaccurate alerts due to poorer or different performance in pediatric populations. General and Special Controls
- The inability to make appropriate treatment decisions when glucose values are unavailable due to sensor signal drop-out or loss of communication with digitally connected devices. General and Special Controls
- Patient harm due to insecure transmission of data. General and Special Controls
- Use of an iCGM as part of another digitally connected medical device system, such as an AID system, when the iCGM has inadequate analytical or clinical performance to support the intended use of the digitally connected device. General and Special Controls
REGULATORY PATHWAY: De Novo request
- An earlier generation Dexcom G5 system, received FDA approval in 2016 but was not designed as an integrated system to be used with compatible devices
- Regulation Number: 21 CFR 862.1355
- Classification: III
- Product Code: QBJ
- Earlier generation Dexcom G5 system, covered by Medicare
BLINCYTO (blinatumomab) for injection, for intravenous use
SUPPLEMENTAL INDICATION: Treatment of B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children.
ADDRESSING UNMET NEED:
- First FDA-approved treatment for patients with MRD-positive ALL
- Approximately 5,960 people in US will be diagnosed with ALL this year and approximately 1,470 will die from the disease
- Single-arm clinical trial, n=86, in first or second complete remission who had detectable MRD in at least 1 out of 1,000 cells
- Efficacy: Achievement of undetectable MRD in assay that could detect at least one cancer cell in 10,000 cells after one cycle of Blincyto treatment, length of time that the patients remained alive and in remission (hematological relapse-free survival)
- MRD was achieved by 70 patients, >50% patients remained alive and in remission for at least 22.3 months
- Adverse Effects: Consistent with other uses. Infections, pyrexia, headache, infusion related reactions, neutropenia, anemia, febrile neutropenia, thrombocytopenia
- Boxed warning: Cytokine release syndrome, Encephalopathy
- Serious risks: Effects on the ability to drive and use machines,pancreatitis, and preparation and administration errors
REGULATORY PATHWAY: sBLA
- First approval in 2014 for treatment of Philadelphia chromosome (Ph)-negative relapsed or refractory positive B-cell precursor ALL
- This application granted Priority Review, Orphan Drug Designation and Accelerated Approval
- Based on MRD response rate and hematological relapse-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
- Accelerated Approval requirements: Randomized trial to verify clinical benefit in adult and pediatric patients,
- Modified REMS
- Eligible for inclusion in the Durable Medical Equipment (DME) External Infusion Pump Local Coverage Determination (LCD).
Lifeline/ReviveR ECG and DDU Automated Defibrillators
INDICATION FOR USE: For use on victims of sudden cardiac arrest (SCA) who are:1) Unconscious and unresponsive; and 2) Not breathing or not breathing normally.
- 2 multifunction defibrillation electrodes, placed on the patient’s chest, to acquire a patient’s electrocardiogram (ECG)
- If abnormal heartbeat detected, it may advise the user that a high-energy shock is necessary
- User interface will provide text/icon prompts and voice instructions to guide the user through the rescue process including cardiopulmonary resuscitation (CPR)
- Will provide an audible rhythmic beeping sound to help the user deliver the correct rate of compressions while giving CPR
- If defibrillation shock is required, the device will prompt user to deliver an electrical shock, through the electrodes.
REGULATORY PATHWAY: PMA
- Product Code: MKJ
- Classification: III
- Regulation No. : 870.5310
- Description: Non-wearable prescription use only AED
Image credits: Dexcom, Amgen, Defibtech