Let's say there's an Android app which connects via bluetooth to a blood glucose meter and then relays live or stored information on the meter over the internet to your doctor, who then may use the information to make decisions on your treatment.
Refer to all the questions I asked in the discussion topic: Antibiotic-releasing hip stem, and answer them for this object.
Each year, this question gets more interesting because the FDA is starting to pay more and more attention to the topic. Can you do an internet search and find some of the latest announcements or opinions from the FDA on this very thing?
This is a pretty exciting topic, in my opinion. See what you can find!
Spiral Medical Development
www.spiralmeddev.com
1. I found Dexcom as the only FDA-approved Continous Glucose Monitoring System that does not require pricking the fingers.
As of Dec 20, 2016, the FDA "expanded the approved use of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetes treatment decisions in people 2 years of age and older with diabetes. This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test."
Dexcom: The Dexcom G5 Mobile Continuous Glucose Monitoring System (Dexcom G5) consists of an externally-worn glucose sensor that continuously measures glucose levels and displays the 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). It is currently available on Android app users within the US.
2. iHealth Smart is a wireless Gluco-Monitoring System. It also approved by the FDA but it requires pricking the fingers.
("Health 8G5 and BG5L Wireless Smart Gluco-Monitoring System consist of blood glucose meter, single-use test strips, sterile lancets, lancing device and the control solutions. The new device Health 8G5 and BG5L Wireless Smart Glucose meters are based on an electrochemical biosensor technology (electrochemical) and the principle of capillary action. The new device Health 6G5 and BG5L meters can display the test results itselt, it can also transmit the test results to an iPhone, iPod touch or iPad through blue tooth.")
References:
https://www.dexcom.com/get-started-cgm?#safety-information
https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm534056.htm
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm533969.htm
https://www.accessdata.fda.gov/cdrh_docs/pdf12/K123935.pdf
In January, 2015 permitted the marketing of mobile apps for continuous glucose monitoring. That release was specific to Apple iOS supported applications. As mentioned above, Dexcom Share Direct Secondary Displays system is first of its kind to offer a legally marketed solution for continuous monitoring. This device has a small wire like sensor that is inserted under the skin. The actual device is worn externally and has a continuous display of glucose for patients who have acute diabetes.
The FDA reviewed the Dexcom Share system under the de Novo classification process."A regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by the device maker showed the device functions as intended and transmits data accurately and securely." Since the risk is low to moderate, FDA has classified it as a Class II. Due to this, if there are other systems in the future like Dexcom, then they will be exempt from pre market clearance from FDA. But they will have to register their device to FDA.
There is also a device approved by FDA known as the Medtronic’s MiniMed 670G hybrid closed looped system. This is "intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes." However, this contains a sensor under the skin and a catheter attached to the device. It has a display on the device but not through a phone app.
I found some examples of mobile medical applications the FDA has cleared or approved since 1997 from this link https://www.fda.gov/MedicalDevices/DigitalHealth/MobileMedicalApplications/ucm368784.htm , also, FDA regulates mobile medical apps so Consumers can use both mobile medical apps and mobile apps to manage their own health and wellness, such as to monitor their caloric intake for healthy weight maintenance. · FDA defines Mobile Medical Application (Mobile Medical App) to be used as an accessory to a regulated medical device; or to transform a mobile platform into a regulated medical device.
FDA intends to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended. The FDA strongly recommends that manufacturers of all mobile apps that may meet the definition of a device follow the Quality System regulation (which includes good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.
The FDA posted an article 3 days ago entitled “FDA approves first continuous glucose monitoring system for adults not requiring blood sample calibration” The FreeStyle Libre Flash Glucose Monitoring System is a class III device by Abbott Diabetes so it would need an IDE and a PMA. It works by using a small sensor that goes under the skins surface to continuously measure glucose levels. Patients can view results by waving a mobile reader over the sensor wire. This Device is regulated by the CDRH continuous glucose monitoring for adult patients without finger stick. The only clinical trial information I could find on this was done on individuals aged 18 and older with diabetes. They investigated the device’s performance by comparing readings obtained by the FreeStyle Libre Glucose Monitoring System to those obtained by an established laboratory method used for analysis of blood glucose. This study was done for PMA.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm577890.htm
https://www.clinicaltrials.gov/ct2/results?term=NCT02073058
I Found that:
Ascensia Diabetes Care announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CONTOUR NEXT ONE Blood Glucose Monitoring System (BGMS), marking a key step in making the next-generation system available to people living with diabetes in the U.S.
The CONTOUR NEXT ONE system features an easy-to-use blood glucose smart meter which links to a mobile device via Bluetooth connectivity. The meter connects to the CONTOURTM DIABETES app, a mobile app that collects, stores and analyzes patient blood glucose measurements delivered to it by the meter. The blood glucose measurements can be used to identify patterns and trends that may help patients understand how certain aspects of their daily activities affect their blood glucose.
To take a tangent off what you said, it is exciting to see Wireless medical devices, mobile medical apps
and health IT becoming more and more prominent. It's also reassuring to see that the FDA is taking steps to have regulation set on that part of health technologies. With the advancing of wearables and their ability to track health, it can soon require FDA approval. For example, medical apps require going on "Federal Trade Commission’s website to find out when FDA, Federal Trade Commission (FTC) or Office of Civil Rights (OCR) laws apply." It is also good to see that the Center for devices and radiological health has a digital health program to better protect public health. With these new technologies coming out to support efficient testing and monitoring, it is reassuring to see the FDA try to keep up with the exponential growth of technology.
Going on a tangent as well - I understand the idea of simplicity that technology adds. But to turn an app into a medical device that is used by doctors to make decisions seems foolish. I'm for the idea of "mobile apps that pose minimal risk to patients and consumers" mainly for things like monitoring or tracking. But I don't think a phone was meant to be turned into a device. If this is an app, any one can just download and use it? How do you regulate that? How do you regulate bugs or glitches within an app? These are just some questions that come to mind, that I don't think are clearly laid out or explained yet.
I read an article about some rumors that Apple is trying to come up with a watch that continuously measures the blood glucose level. In the early 2000s, the FDA approved a device called the GlucoWatch. It used a low electrical current to draw glucose right out of the body, where it was measured by sensors on the back of a tight-fitting watch. The problem was that the device was a pain to use: it caused a bad rash underneath the watch for 80 percent of the people who used it, according to an evaluation by ECRI Institute, a nonprofit research organization. It also took three hours to warm up before it could take a measurement; people with hairy arms needed to shave a clear patch for the sensor; and it didn’t work if the user got too sweaty.
A noninvasive glucose monitor would probably fall into the category of a Class III medical device which would require the company to get a pre-market approval, which can take years can take years.
1. https://www.theverge.com/2017/5/25/15685148/apple-watch-glucose-tracker-blood-sugar-monitoring-diabetes
On January 23 2015 the FDA approved marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone. The Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data. A 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). CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates. 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.
2. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm431385.htm
I searched about the app for measuring blood glucose. Philosys, secured approval from the U.S. Food and Drug Administration for a portable blood glucose meter that hooks into Android devices through the headphone jack. It had previously received 510(k) clearance for a version of the device for iOS network devices.
Philosys is part of a broader trend of innovative approaches to blood glucose monitors and meters connected to smartphones. So far Decosys looks like the smallest and cheapest of the smartphone connected meters to date. Earlier this year, Dexcom got FDA approval clearance for apps to continuously monitor blood-glucose levels.
Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two different aspects of the device. The test strips are as important as the stability of the software running the device and both need to be regulated separately. In a recent article, the FDA after being reported by users of glucose monitors about the false low-level detection of glucose, points out that care should be taken by pharmacists and caregivers to use test strips that are specific to the particular meter that is being to used measure the glucose levels.
In a very latest update last week Sep 27 2017, the FDA released an article that outlines the risk of absence of real-time alerts or alarms in situations like when the patient is sleeping. The FDA maintains that the information provided by software/mobile controlled non-invasive glucose meters in such cases maybe inaccurate and may still lead to non-alerted incidents of hypoglycemia and hyperglycemia.
Blood glucose monitor can be considered a combination product as the sensor/ test strips that detect the blood glucose and the software that computes the calculation of these glucose levels are two different aspects of the device. The test strips are as important as the stability of the software running the device. In a recent article, the FDA after being reported by users of glucose monitors about the false low-level detection of glucose, points out that care should be taken by pharmacists and caregivers to use the test strips that are specific to the particular meter that is being to used measure the glucose levels.
In a very latest update last week Sep 27 2017, the FDA released an article that outlines the risk of absence of real-time alerts or alarms in situations like when the patient is sleeping. The FDA maintains that the information provided by software/mobile controlled non-invasive glucose meters in such cases maybe inaccurate and may still lead to non-alerted incidents of hypoglycemia and hyperglycemia.
The blood glucose meter is an existing product and as such is class 2. It is a medical device and falls under CDRH. The interesting component is that is transmits data to an android app. The thing in question here I feel is the sending device, not the receiving device. The part of the glucose meter that sends the data might be subject to safety concerns. However, devices that send/receive data are already on the market, such as implantable vagal nerve stimulators. So there is a good chance that this part of the device can be proven equal in function and thus the device as a whole is class 2. The fact that a doctor can recommend treatment changes because of this data I feel is out of the FDA's jurisdiction. The doctor's treatment recommendations are the doctor alone. He/she has the most knowledge and is ultimately responsible for their case.
An online search for a blood-glucose monitoring-system came across the FDA-approved Bluestar app by Welldoc. It is a Class II device (not a combination device) that has proven substantial equivalence under a 510(k) (1). It is intended for adults diagnosed with type II diabetes that is defined as "prescribed mobile therapy" that was successfully implemented to be a more cost-effective method for diagnosing the severity of one's condition while also setting reminders for a patient to take medication or maintain healthy diet and exercise. Some confusion that can arise in this topic is that the FDA's approval on the app refers to the app itself, not the monitoring device the pricks the patient. Simply put, the FDA is focused on whether or not the app can properly connect to a blood-glucose meter and transmit data, not on the safety/risk of the meter as it physically analyzes a patient (which has already been established prior to the founding of the app). This may then bring to question as to why a minimally invasive device is labeled as a Class II rather than a Class I, and the reason for that is most likely because the wireless transmission from the device to the app carries risk in itself. If the app misreads the blood-glucose meter or misinterprets the patients blood-sugar levels in any way, then it could result in a patient taking medication that they do not need, or worse, not taking medication that they do need. The FDA requirements are therefore put in place to address that risk and prevent it from occurring.
(1) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162532
An example of FDA approved wireless medical devices is the wireless electrocardiogram. It consists of the ECG monitoring circuit, microcontroller circuit, and an Android mobile phone. The phone has a function that detects if the wearer has fallen down and hasn’t moved for a while, and can call for help. The microcontroller interfaces to Android mobile phone via Bluetooth protocol and the information is relayed to the database server via FTP protocol. Each patients' monitor, which also communicates with the hospital’s 802.11b network, continuously sends the electrocardiogram data to the network. Meanwhile, the doctor can monitor this data from anywhere in the hospital using his handheld PDA, thereby completing the entire electrocardiogram monitoring process without a single wire.
