Insulet, Dexcom agree to develop integrated pump-CGM

This is probably no real surprise, as I'm sure everyone knew the companies were moving in this direction, but it made the business wires last night. Insulet reports quarterly earnings Thursday, so maybe there will be some discussion during the management conference call.

Seems like we have heard this before.

I used to think this would be a great thing, but, have since reconsidered.

While Dexcom has made great progress with the G4, it still isn’t quite good enough to auto adjust dosing. I do use it to help with a bolus along with how I feel and sometime a finger stick, I wouldn’t want it to do it automatically.

I also get 2 weeks plus with the G4 and the pod has a hard stop at 80 hours.

A converged controller would be nice. Unfortunately the Omnipod controller has gotten worse over time and the same form factor. I guess related to the cost of developing and certifying a new life critical device. It is worse in that there are lots of extra steps that are not optional and only needed if you have more than one person with a pod. This is great for something like diabetes camp, but, annoying day to day.

Yes these are small things,but, it just adds to the overall burden of managing things. Don’t get me wrong I love the wireless, tubeless pump design and compared to mdi and lantus I get much better control and can manage bg on the run, in meetings, etc.

I understand there are barriers to doing this, but, having a option to use tech like Bluetooth le to have you phone control the pod and get readings from a g4 like device would be truly awesome. Include an open data and API format for data and people could write all kinds of apps for analytics and near real time sharing and collaboration with parents, health care providers, and your endo. The less friction in the process the better the care can be and you should get better outcomes.

i would be concerned only for insurance purposes, at the moment my insurance will pay 100% for my pump but nothing for my CGM. so if they were integrated what would happen to my insurance?

That's how I feel too, though in my case I was never able to get the Dexcom to work (this was a couple of years back, prior to the G4).

Low energy BT with good encryption is the only way to go. Having a published interface would potentially allow Insulet to get out of the PDM business, however I think the current PDM more than adequately demonstrates that all the difficult regulatory issues are in the PDM so I suspect the only people who would benefit are the relatively few diabetics who can write their own software.

I doubt anyone who want to risk publishing an open-source PDM program, though I guess diabetics could cooperate on development with too much risk of either being sued or have the FDA jump up and down on top of us with pointy shoes.

I'm sure the integrated device would be an option and pump-only would remain.

It's been on and off for a while. Not sure the reasons, but apparently if they've finally reached a good agreement, then maybe they'll get somewhere.

Do you have any links for news on this?

There was a cgm/ pump information thing going on about a month ago where I live, and as I was waiting for the Dexcom representative to finish with someone, I started talking to the omnipod rep. She told me that it would be a few years yet until Dexcom and omnipod integrate. She said it was being tested on animals right now.

Actually, the announcement I read was a little misleading. The companies are working to integrate Dexcom CGM readings into Insulet's Personal Diabetes Manager, which will be Bluetooth-enabled. What was announced is not any type of closed system, nor is it a pump/CGM, merely a PDM that can also receive CGM data. Sorry for the confusion.

No, you are right because it's related to next generation Dexcom sensor, the G5.
The G5 transmitter will be "clever" and transmit over bluetooth 4.0 directly the computed BG value.
The new PDM will receive the value and graph it.
No closed loop though.

I have to admit after three days on MDI because I was diving (so too deep under water for the pod) I'm considering abandoning the Insulet blood glucose handling and using a separate app on my telephone.

The PDM is very happy to tell me what bolus to give after I do a test and enter carbs, but it doesn't give me the option of saying that I've done that via separate injection. As a result after the first shot the PDM insulin-on-board is wrong.

I kept on being reminded that if I use a separate app I'd have a better model of insulin and, maybe, carb adsorption. I could use this with the PDM simply by using the bolus menu to deliver a specific amount - given all the extra confirmation screens it's probably *less* typing doing it this way!

So I guess what I'm saying is that tighter integration isn't really attractive to me given what Insulet have done with the PDM user interface and the lack of a good model of insulin adsorption.

John Bowler

No pump lets you insert insulin delivered by other means.
You are supposed to use your pump, or not. Not to mix things up.

Out of curiosity, would a pressurized suit let you wear a pod? I think the main problem is bubbles forming in the reservoir due to pressure.

Well... clearly if there is no pod I'm not using the pump to inject insulin, so if I don't change the pod for 48 hours (as happened last weekend) I *must* have injected insulin, so I almost certainly have insulin-on-board when I activate the next pod. So by not allowing me to update the insulin the PDM is guaranteeing that it will do the wrong calculation.

The only PDA app I've been able to find so far that appears to do the bolus calculations is "RapidCalc", and that doesn't support Android.

I'm not sure what you mean by a pressurized suit; the problem is the *increase* in pressure, to about 1.75 atmospheres (1.75 times typical surface pressure) at 25ft. There's no problem if the pressure doesn't increase; diabetics can look at the big tank in the Monterey Bay Aquarium and that is deeper than 25ft, but if we get into the tank with a pod on that would be a problem ;-)

The issue is that there is a vent in the pod (the "housing vent" - see the picture on page 4 of the manual). You can see the vent easily if you pull the adhesive off; it consists of three small holes covered by a filter (scrub the filter off to see the holes.) This allows fluid from next to our bodies, typically air or sweat or both, to enter the space behind the plunger as the plunger injects insulin. So over the life of the pod up to 2ml of air/sweat/water (the latter if you swim for a long time) gets sucked in behind the plunger.

However when we dive below the surface or go up in an aircraft the hole also has to accommodate the change in air pressure throughout the pod. The pressure change is about a doubling, so a total volume of fluid up to 2ml+the volume of the air in the rest of the pod will get drawn in then expelled. This fluid includes our own sweat and if that gets onto the motor wire the pod will probably fail.

It is difficult to work out the worst case. Each pressure increase introduces some fluid into the pod then the following decrease expels it, but the process takes some time. A dive to 25ft for one hour will certainly introduce significant water into the pod, but repeated dives to the bottom of the pool while swimming for one hour could potentially introduce then expel a far greater total volume!

What is certain is that diving to the depth scuba divers reach (normally at least 30ft) will exceed the pod capacity to handle the introduced fluid. A recreational scuba diver can get to 130ft and the pressure at that depth is five times that on the surface. At this pressure pretty much all the space in the pod would end up full of water; only 20% of it would still be the original air. That's a guaranteed pod fail, but then any 5x pressure increase will cause 80% of the water vapour in the pod to condense all over the pod electronics.

John Bowler

I just watched an interview with Dexcom CEO Terry Gregg in which he said that Dexcom is "an Apple developer" working with the company to enhance health-related apps on iPhones. I hope this connection is or will be a catalyst for Insulet to do the same, given the partnership between Dexcom and Insulet.

is this what you may be talking about Jim?

Looks like it. Pretty much locked in with Apple phones as of now. Apple is making a strong push into the health care space with new apps coming soon.

well I am good with that being an apple gal. lol

Dexcom said its G5 will have no receiver, only apps for smartphone and the first to be submitted to FDA will be for iPhone.

Totally bogus patent of course; it was done 20 years ago with the Palm Pilot and existing glucose monitors:

The really sad thing is that this is a patent war being fought for financial gain over our dead and dying bodies.

John Bowler

I have heard from my endo dr this past week that in about 6 months OmniPod was coming out with one that has a CGM &POD that was going to be controlled by a app on cell phone. Replacing the PDM. I would love to find out more about this.