Today there are a flurry of new medical devices that measure.. people. Whether that measurement be of temperature, blood oxygen saturation, sugar level in diabetics, muscle quality, weight, ECG systems or asthma air flow meters, patients have an improved quality of life being able to separate themselves from a hospital and still carry out needed testing or daily maintenance, wherever they may go.
Each of the applications have devices approved by the FDA and each of these applications have devices with varying modes of data transfer.
- Many devices use on board memory and rely on medical facilities to download that data.
- Some devices allow users to upload data via a USB port and PC/Mac computer.
- A few devices now offer Bluetooth (with recent BLE implementations) connectivity to smartphones for data review and upload to the cloud.
Enter game changing technology.
Earlier this year Verizon announced the release of Category M1 connectivity on their LTE network which has started to be deployed and will be completed in 2017. The other networks are thought to be about one quarter behind Verizon’s lead. M1 is meant to be the first real answer for wide area Internet of Things deployment. LTE M1 offers low bandwidth, high availability and low cost access to the Mobile Carrier network. For some, the M stands for Machine as it has been intended to connect millions of devices that do not need a more expensive connection.
M1 over LTE Networks can change the landscape and improve effectiveness of personal medical devices. By integrating M1 chip sets (<$10 in volume) into medical devices, patients and their care givers can now send real time data directly to the cloud, to doctors, and to caregivers and eliminate several requirements on patients.
Data Connectivity alone, the three examples above have obvious improvements
- No longer dependent on patient transportation, real time data changes review capabilities
- No longer dependent on patients desktop or laptop computers, or those of their relatives
- No longer require users to have a mobile phone (especially important for children, and the elderly)
Data Security Benefit
As with any medical device, the deployment of LTE M1 connectivity will take time as FDA Approvals will be required where applicable. A benefit that LTE M1 offers over Bluetooth connectivity is it’s security profile.
From a hardware and spectrum argument alone, bluetooth devices are more susceptible from hack attacks because of the general availability of 2.4GHz spectrum tools and devices. Emulating an LTE tower in a completely different radio frequency spectrum in order to hack a device is, physically, a more harrowing feat. (This argument does not include the discussion of additional security and safety protocols, just the argument of hardware availability)
LTE M1 technologies do add new players into the mix, in terms of data transfer and storage. The data uploaded through the likes of Verizon has to be stored somewhere. And with a possible army of such devices, connection to local doctors offices may prove difficult. For that reason, Internet of Things players such as Amazon, Google, Microsoft, Hitatchi Data Systems, Oracle, with hardened data security protocols and pre-built human interfaces will be part of the flow of data. Hallsten Innovations has had successes with other Internet of Things Deployments using tools from these vendors.
This is Real Life
A friend of mine heard me talk about M1 a few weeks ago, and he showed great interest. Matt has two children with Type 1 Diabetes. This disease has left each of children with a pancreas that no longer produces insulin- making them insulin dependent. Constant blood sugar checks are needed to keep each of them within a healthy blood sugar range.
For school age children, this sugar checking happens at schools 2-3 times a day in the care of nursing staff or teachers that may have no idea what to do for the children. For parents that offer care day and night, letting them go is difficult and scary.
LTE M1 connected insulin pumps, glucose meters, and continuous glucose monitors(CGMs) would inexpensively give parents peace of mind, and allow for real time interaction with school staff to take directed action, or for parents to intervene.
While bluetooth connected insulin pumps and blood sugar meters are on the market (see below), these often require a mobile phone that can either be distracting to a 4 year old, resisted by the school system, or not affordable.
LTE is going to change things for the better for Insulin Pumps and Meters
A Diabetic may use 1-3 of the below technology tools:
1- A Digital Meter for blood sugar testing (finger prick)
2- A connected pump to provide insulin directly to the body (replaces insulin shots)
3- A Continuous Glucose Monitor (CGM) to constantly measure blood sugar (replaces some finger pricks, provides helpful data)
There are five major insulin pump companies serving Diabetic needs today with different devices: Tandem’s t:slim, Roche’s Accu-Chek, Omnipod from Insulet, the Medtronic 530G, the Animas Vibe, and the G4 CGM from Dexcom.
Although there are dozens of advantages that each device can claim, and drawbacks, let’s look at their connectivity options today.
The Tandem t:slim line: This one piece insulin pump must be physically attached to Desktop/Laptop and have data uploaded via t:slim specific software. The t:slim can only wirelessly read data from a Continuous Glucose Monitor worn by the patient.
Roche Accu-Chek Combo: Two devices- one a sugar meter and the other an insulin pump, the devices connect to each other via Bluetooth, but to no other devices. Data must be uploaded via Infrared to a provided IR port attached to a desktop computer.
Insulet Omnipod: A two piece device with the pump worn directly on the skin, the remote/meter must be connected directly to a PC for data upload.
G4 from Dexcom: The G4 is a Continuous Glucose Monitor and not an insulin pump. This 2 part device connects to a smartphone via Bluetooth for helpful data display and warnings. Data can be shared with others once it reaches the phone and application.
Medtronic 670G with Guardian CGM (2017): This insulin pump device can communicate to the Guardian CGM devices worn on the body and recently made news as, in part, an artificial pancreas. Medtronic Smartphone Connections via Bluetooth are pending and coming soon.
The Animas Vibe must also be connected to a PC for data download, but does connect wirelessly to CGM devices worn on the body.
Lastly, new to the arena, Bigfoot Biomedical promises to change the world with connected artificial pancreas technology. We shall see what they deliver soon!
Now, this is just the Internet of Things side of my brain talking, but, does it not make sense that these devices could benefit greatly from a connection to the cloud? M1 would eliminate the need for PCs, laptops, and even smartphones for children or those that choose to go without. M1 could connect data to worried parents, allow doctors to make recommendations for insulin ratio changes constantly. With the low costs that M1 promises, I wonder which device manufacture will make the first offering?
For the benefit of Matt and his family, I hope it is soon.
We’re Here to Help with M1 Integration
I mentioned in the previously linked post, I was giddy when LTE M1 availability was announced by Verizon. As a developer of electronic solutions for the Internet of Things, know that LTE M1 integration is part of my toolkit, and likely will be for a long time ahead.
If you are a medical device developer in need of a specific M1 / Internet of Things solution, please contact us. We can add the connectivity “smarts” which can make a difference not only in Matt’s family but with the rest of the world.