The new Omnipod PDM, How I hate thee (or the FDA, not sure who is to blame)....and now Insulet

First, the new smaller pods are great. Then the PDM which is not so great:

1. Why do I need a PDM ID screen? (Is there a thought that a whole gaggle of us diabetics are getting together and throwing our PDM's together for fun to see who brings the right one home at the end of the night?)
2. Temp Basal. Previous you could say temp basal and go up a % or down a %. Thanks insulet for thinking we are not smart enough to understand a negative means less, so now we have to click increase or decrease and then dial up the %.
3. The beeping. The beeping. The beeping. An incessant beeping and vibrating after an hour and half to check that the pod is working correctly? Thanks big brother but I don't need the reminder.

The added kicker, today I learned that without my ok Insulet went to my insurance company as I was out of warranty and signed me up again. I received a new PDM in the mail with my podd re-order. WTF? I never received anything or gave them the ok to do that on my behalf. While I appreciate that Insulet thinks they will have an invention that will allow infusion of insulin along with CGM at some point in the future, I would like to keep my options open for the VIBE and hopefully T-slim getting FDA approval next year for a combined device.

Views: 393

Comment by Don on November 1, 2013 at 9:58am

I have wondered the exact same question whether the FDA or the pump companies are more to blame for certain idiotic design decisions. My guess is pump companies are very aware of the ergonomic deficiencies of their pumps but cannot or will not incur the expense and time necessary to get FDA approval. I've come around to blaming the FDA more. Safety is being prioritized to the point of going against common sense. I suspect pump companies sometimes proactively throw in safety measures (e.g., PDM id screen?) just to avoid potential expensive FDA delays. I wish FDA regulators and pump engineers had to use these products on themselves for an extended period before pronouncing them ready for us. Extra button presses and alarms can seem sensible and worth-while at first but day in, day out the reality sets in.

Comment by Clare on November 2, 2013 at 8:55am

I originally had all the same complaints about the PDM as you do. Then I figured out if they're going to make me confirm every single time that yes indeed this is my PDM then I would have some fun with it. So far I have changed my ID 4 or 5 times

While I am not taking full credit for the Red Sox winning the World Series, I think every little bit helps :)
The beeping can be turned off. If you go to the settings under system set up, alerts and reminders, check and makde sure that the "confidence reminders" is set to OFF. Then it won't beep at you while you bolus nor will it beep when it finishes a bolus and it won't beep at the beginning or end of a temporary basal etc. Also in the settings you can set it to only vibrate. The 1.5 hour reminder to check your blood sugar is annoying but I have found if I change a pod late at night, I just stick the PDM in a drawer and don't notice the vibration at all.

Comment by Clare on November 2, 2013 at 4:45pm

Blame the FDA and the SINGLE patient with D who just didn't follow the very explicit directions when using the PDM in the clinical trials.
You can stop the beeping by going to the settings menu, system setup, alerts/reminders, and turn the Confidence reminders to OFF. The confidence reminders are supposed to make you "Confident" that the pod has delivered your bolus. This is what causes the beeps at the beginning of a bolus or at the end of a temp basal. It's impossible to get rid of the 1.5 hour post pod change blood glucose reminder, but you can just set the PDM to only vibrate. But if I change the pod late, I just stash it in a bedside table drawer and it doesn't wake me at all.

Comment by Sheri on November 4, 2013 at 8:18am
From what I've heard from my doc's office, Insulet has stopped making the old pods & the new pods are not compatible with the old PDM so that is why you got a new PDM. Everyone who has an OmniPod should be getting new PDMs. However, I'm in total agreement on all of your complaints. Especially the reminder beeps. I always change my pods before going to bed and the PDM is always waking me up!!
Comment by ScottD on November 6, 2013 at 3:02pm
I have to agree David. From what I was told by some companies they are being required to add these "safety" features from the FDA as a new standard by the FDA.
Well, for kids it may be safer, but no thanks. Give me the option to turn off some of these so called safety features or I will be hacking my pump like I do my iPhone or wireless router. After all, it's just software.
But at least the good people at the FDA can sit back and say "we finally did something" or "look what we did to justify our salary" after not changing anything for years. I remember someone writing that they should have to wear a pump with saline to see the difference they made. Most diabetics I know have a better understanding of their own health as self taught doctors, and we have this federal agency with people making decisions that might not even understand the basic concept of the common flu. Things don't make sense these days and seem to be getting worse.


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