The trials sound very interesting and it looks like they've made a lot of progress. It's also good to see the interest in diabetes that has been generated due to the artificial pancreas project.
This is because of the recent NIH, FDA, and JDRF 2-day collaborative workshop on the Artificial Pancreas. The sessions were recorded. You can see the video for day one here, and for day two here.
The agencies and people involved seem to be taking a very pragmatic approach to combining the individual technology pieces to this puzzle. All of the required pieces of hardware already exist, the hard part is getting the software to work so that insulin and blood glucose controls can be automatically controlled. Thankfully those involved seem to be working to get a solution that's usable rather than a 'perfect' device. Hopefully the early prototypes will quickly inform folks about ways in which the overall approach can be improved.
The CBS piece mentions that the artificial pancreas may be available in 5 to 10 years.Because of approval and regulatory issues, I would guess this is closer to 10 years out. I hope it's a lot sooner than that.
They're working on developing a closed loop system where readings from a continuous glucose monitor (CGM) are used to directly control an insulin pump. Currently those of us with CGMs and insulin pumps have got an open loop system, we need to take the readings from the CGM and decide whether we need insulin or food.
Clearly this is a difficult problem to solve. How would such a system know if you were sick? What would it do when you're about to exercise? How would it handle changing insulin needs for children who are growing?
Now you have a chance to learn more about this project. On July 21st and 22nd the FDA, NIH and JDRF are holding a public workshop 'focused upon the state of the art in the research and development of an artificial pancreas'.
The meeting will be in Bethesda Maryland at the NIH campus. Building 38A on this map. Space is limited so you do need to register.
I would love to go to this workshop, but I'll be out of the country.
Can I ask you a favor? If you go the workshop can you write up a summary of what's discussed and post it to the blogosphere?
Attribution: The illustration above is from the JDRF site.
The FDA has a new approach for reporting problems with blood glucose meters and continuous glucose monitoring systems (CGMS).
Once a glucose meter or a CGMS goes into widespread use, unforeseen problems may arise because FDA's approval process cannot always detect adverse events that are rare or related to the clinical use of the device or the users’ techniques and skills. FDA also cannot always detect manufacturing problems or problems with the product labeling (including instructions for use) after the device is on the market.
If you use any of these systems they'd like to hear from you when you encounter any of the following type of problems.
Device problems including
reagent or instrument failure
defects in product design
product instability
any other device problems that compromise patient health or safety
failure to perform according to performance characterized in package insert
incorrect test results that cause or contributed to an incorrect patient diagnosis and/or treatment
Use-related problems including
inadequate and/or misleading labeling or confusing user instructions Use-related problems
inadequate packaging or poor package design
any other user problems that compromise patient health or safety
The FDA will hold your identity in strict confidence. This means they won't release it to the public. But they may share it with the maker of the device, unless you request them not to do so.
Finally a way to get attention to system issues that annoy you! Full details on the FDA website.
Dexcom SEVEN is cleared to calibrate with any meter
Dexcom announced today that it had received clearance from the FDA to calibrate its Dexcom SEVEN continuous glucose monitoring system using any approved blood glucose meter.
Once this feature is made available, Dexcom users will no longer need the dreaded six foot plus calibration cable. It'll need a software update to allow input of the glucose meter values. I hope they use a good algorithm to let us input those numbers!
Dexcom expects to make this feature available on new systems by the end of the first quarter of 2008, and to upgrade existing users during the second quarter of 2008.
I know that they've already started trials on their 3rd generation system, but so far there's no news about the upcoming features in the 3rd generation or the likely date for the system.
According to the page the Dexcom SEVEN was approved on May 31st, and a pointer to the approval letter(PDF) is provided. So Dexcom really didn't delay at all before telling us about it.
It's interesting to see the history of the Dexcom filing with the FDA
Filed: June 9, 2006 Amended: July 11, August 4, November 21, November 24, and November 28, 2006, and February 9, April 20, and April 23, 2007
I don't think this amount of filing is unusual, but it gives some insight into the amount of work needed for FDA approval.
Two points in the background notice jump out for me. The first I already knew and the second is a little vague:
Use of acetaminophen-containing medication when the STS-7 sensor is inserted may affect the performance of the device.
The Dexcom STS-7 System must be removed prior to MRI
Does this mean that I need to remove the sensor and the transmitter before an MRI, or that I just need to remove the transmitter? I'll have to clarify that one with Dexcom. Update: I exchanged emails with Dexcom customer support. When having an MRI I need to remove the transmitter and sensor and leave the entire system in another room.
If the FDA only points out issues with acetaminophen, then it appears that use of other drugs doesn't cause issues. That's good, because I've already seen the impact of acetaminophen on the Dexcom STS that I'm wearing and it's not good.
I'm still waiting on my Dexcom SEVEN. I hope to see it in a week or so.
Note: I currently own some shares in Dexcom, I work not to let this ownership influence what I say about the company or its products.
The MedApps system is designed to transmit glucose readings to a central server by way of your cellphone. It's now been approved for over-the-counter use.
The illustration from MedApps all show a OneTouch Ultra meter, but their information claims 'the BluePAL technology wirelessly transmits data from 20 of the most popular glucose devices from 4 of the leading manufacturers'.
They provide a device (Polymap Polytel) that connects to the meter and sends the data via Bluetooth to your cell phone. The cell phone transmits the data to a MedApps central server. The system can be setup to send alerts to healthcare providers based on per-patient thresholds.
It all sounds interesting, but there's a lot of steps from meter to software. Now if all the meter makers agreed on a single data standard, this would all be a little easier.
I know you're going to think that I've lost my mind. Because what I'm complaining about may not seem that important to you. But it is probably a lot more important than you think. So bear with me.
On Tuesday, I went for an eye doctor appointment to see what was going on with my right eye. I've had some blurriness in the central part of my vision for a while. So the doctor decided to take some pictures while injecting a fluorescent dye into me. That way if there are any issues, they'll show up clearly in the camera.
Now being a geek, I thought this was way cool. I asked the man doing the pictures whether I could get copies of them. I figured the kids would be interested in them, and I might post one to the Diabetes Made Visible photo group on Flickr.
Well he mentioned that I'd need to fill out some paperwork and then he could print me some copies. But I didn't want paper copies. I wanted the high resolution photos that I saw on the screen in front of me. So I said, "well I just want to take them home on a Flash drive". His immediate response is "no, you can't take the files".
Now it's not like I'm removing them. I only want a copy. When I pushed him on this, he said they're "scared what you might do with them". Now can you think of something terrible I might do? Print big posters and e-mail to folks causing heart failure? What's possible bad thing could I do with close up pictures of the back of my eyes?
So that's bad data day item #1. Oh, and by the way, there's no significant damage to my eye. So we're just going to keep watch on it (pun intended).
After I got home, I spent some time talking with someone in Dexcom. I'm trying to get one of the new Dexcom SEVEN systems with software, so I can review it.
The response is that right now they're trying to get training ready for the systems. So there are none available for review.
While I was talking with this woman, I asked why Dexcom is making it so hard for us to get to our data. Her response is that it's due to FDA restrictions.
This is bad data item #2.
I'm checking now to see if the FDA remark is actually true. I can't find anything in various advisory committee transcripts about this. I've fired off notes to some contacts within the FDA. I'll let you know what I find out.
Did you read my post about Google and health issues? Now how can we get access to our data if you have 'the' diabetes hospital (Joslin Clinic) saying "you can't have your files". And if the FDA or a device maker is saying "you can't have your data".
I'm just steamed about this!!
How can we improve things with a shrinking supply of endocrinologists, and without access to the facts we need to improve our control?
Grrr!!
Update: I currently use four pieces of diabetes-related software. All of them have the data locked down in some way.
Dexcom: Data encrypted or in binary form (unable to crack -- so far)
OneTouch: Data password protected (easy to crack)
MiniMed: Data password protected (easy to crack)
AgaMatrix: Data password protected (easy to crack)
So I think this is a widespread practice. But I can't figure out why.
The FDA has just launched a new page to track the status of patient studies on newly approved medical devices. This will contain information on studies ordered after a device has been in use for a while.
The page currently has information on studies ordered since January 1st, 2005.
The page will be updated on the 5th of every month. Currently there are 44 studies listed, and none of them are related to diabetes.
The Diabetes Technology Blog is focused on using technology to life better with diabetes. I review: blood glucose monitors; continuous glucose monitor; blood sugar meters; diabetes software and living with diabetes.
About Me
Name: Bernard Farrell
Location: Massachusetts, United States
I was born in Ireland and now live in the US.
I have had Type 1 diabetes for over 35 years. I struggle with my blood sugar, the same as most people with diabetes.
I wear a Cozmo 1800 insulin pump and a Dexcom SEVEN CGM to track my blood glucose levels. I also take Symlin to help control my post-meal blood sugars.
I'm blessed by God, and every day brings the possibility of a cure.
They're working on developing a 
