For children and people who want an even smaller Omnipod to be designed

Type 1 and LADA Parents of Children with Type 1 Diabetes
1

I’ve heard from the manufacturer that they have a smaller one aound 200u for the three day reservoir. That would make it on a par with the Solo model by another manufacturer which requires a 70u minimum insertion of insulin. So even that one I can’t get because I gain weight on higher insulin.

I can’t even do that. I’ve averaged 15u TDD for the last 20 years so I need one that is even smaller.

I feel there must be some people with children on a small amount and certainly newly diagnosed people. I have been type 1 for 30 years and have close to zero of my own production of insulin, but still am extremely sensitive to insulin which I attribute to my diet and supplements.

I want them to at least reduce the minimum needed to start the pump. They said in the solo company that it was due to the location of a sensor, so they need to adjust the location of that. I can’t at all even get a pump if it says I have to feed the pump more than I will ever use.

I joined this group because I feel certain there must be some people who agree with me if they are parents of children with diabetes. I have even felt that a lot of diabetics who have gained weight, have done so because of being misguided and instructed to take too much insulin.

I thought the 300u omnipod was made to accommodate people who are of all sizes and shapes, but I was shocked that even the minimum amount would be far more than a great number of people even use. That makes no sense.

Apparently the tubed models of other pumps like the paradigm which is used for small children does not have a minimum required insertion. But tubed models have the problem of crystalization along the tubes. It seems that a very tiny dribble can’t be accommodated so that means a tubeeless model is more important than ever.

Please, let’s make this sub discussion a CRY for another even smaller model. Surely the company can make smaller versions just as T-shirts are made in a variety of sizes. They don’t make eveyone wear the extra large size and then say they have production limitations so only 2 sizes are possible…large and extra large…what about the children and extra small people?

I will have to stay on MDI until a smaller tubeless version is possible with a much smaller minimum insertion of even 15u for a three day period that would be needed for some small children. What it means is that my current approach of 3 overlapping long term insulins is still the best approach with short term for correction factors and small meals as it keeps me slimmer.

The sad fact is the people who are in my positon have already decided MDI is the only option and they won’t be even looking at an omnipod as an option so they won’t see this request for an indication of support for the meed for an even smaller model. I was shocked that the person in customer service wasn’t even a diabetic so how could she even understand?

2

Very interesting issue.

So, to please the most users, the ideal reservoir would have to be bigger, say 300 U, to include people w/ T1 who use a lot of insulin or even people with T2. But it must allow for only filling past, say, the 20 U point.

Yes, the problem with the Insulet pod (and probably w/ the Medingo Solo, I don’t know) is that the sensor that detects the filling is placed at the 70 U (or 50 U ??) point. The reason for that is so the insulin use can be closed monitored, from a “large number” U down, and not be in the “Low Reservoir” state right away, potentially leaving people stranded somewhere without a replacement pump.

The solution to please all would be to have multiple sensors, say, at the 20 U, 50 U and 80 U points. That would make the “pod” or “solo” more expensive (mechanically and electronically). Tough call…

Cheers,
Gil

3

But, I’m not suggesting a one fits all model, but three models. They already have 2 as they did introduce one that matches the Solo size of 200u. I’m suggesting another one that is 100u or half the 200u size. I used the T-shirt analogy of S,M,L. It just means separate runs in production to create three different sizes. There is no need to have three sensors in one.

If it means the pump is going to be sending out an alam the whole time I am wearing it because it thinks too little is in it…I’m glad you reminded me of that…boy there’s a lot of negatives I could say about how being on insulin may even cause shut down of production of insulin, so going the route of more insulin is something I am totally against.

I am very glad to meet you and I’m sorry I sounded aghast that a non diabetic is involved in customer support that I had previously called at one of the companies, but as you are even in design, let me emphasize that insulins that are analogues very likely are partially destroyed each time they are injected especially if in large amounts. That is why I have stayed at such a low amount for 30 years, simply because I have always done MDI in tiny amounts.

I call it “getting it in under the radar” of the immune system. I personally still can not see how some people could take in so much insulin and not be gaining weight unless some is destroyed soon after injected. That is why DrB suggests the rule of small numbers. He says that with large injections there is about a 30% variability in how the body will react to it. So in my view it is evidence that the body sometimes destroys more than at other times and this is more likely for the longer term insulins. People on pumps are having the advantage of such a much lower amount being continually injected that it doesn’t attract as much immune reaction notice. So that would explain how people can take less insulin when switching to a pump from MDI.

Insulin is not always great…it also contributes to heart disease in more than one way, so keeping eating down is best. I know this from having helped a woman who was 110 lbs overweight and on 106u TDD of insulin. She was 250 lbs. She showed me a picture of how great she looked before becoming diabetic 20 years ago.

Let me point out that in my first Pump Meeting/Seminar I was sent on, I was told that pump users tend to take about 75% of the insulin they previously took via Multiple Daily Injections. There is ONLY one logical reason for that and it is the above mentioned advantage of less immune system response when using a stream of short term insulin.

So, please consider 3 different sizes with different production runs and remember they don’t try to sell large T-shirts to children just because it would cost too much to have a different production run.

If the Paradigm doesn’t need a minimum, then neither should a tubeless model.

The company would sell a lot more and put the tubed versions out of business if they came up with a smaller version, as no one wants all the problems of tubes. Furthermore, smaller is better all around.

From what you say, I would be in constant alarm mode. I noticed that a woman in the seminiar admitted she was always getting beeping because she did eat too many carbs and was often over her target range, so I wondered how she could keep a job if she annoyed her co-workers like that. No one can work with alarms going off all the time. But I understand that they can be made into vibrating alarms so that would be less problematic for other people near by.

By the way, I don’t think an alarm needs to be in it for getting close to empty. Doesn’t the hand help PDA just mention the number of amount left? More useful is the ability to stop the drip if CGM drops too low and since that is so expensive and is not covered by a plan I could be on, I decided I could not get that advantage even though it happens to me frequently.

I wish you the best on your PhD, Cheerio to you too.

4

I am just quickly reading this, but the omnipod’s current size is only 200 (220 max). There’s no such thing as a 300u one. So the “smaller pod” you’re talking about is the current size. They are also working on a smaller one that is less surface area (something like 40% smaller), but it, too, will also hold 200 (and I assume have a minimum fill of 85 u like the current one does).
While I agree that it would be nice to have a “variety” of pod sizes to pick from (based on either how much insulin you need on a regular basis, or picking a particular size due to an activity you’re getting ready to do, etc), the amount of red tape and FDA clearance to get something like that through would be pretty difficult. For example the new smaller pod was just submitted to the FDA, and they haven’t changed anything major on it (just shape of reservoir, location of batteries, etc), and the document they were required to submit was still 7,800 pages long.

5

Yes, both models only hold 200 U. Janina was mistaken about the pod’s capacity. I was just speaking in general, about having a wearable/disposable device with 300 U capacity to please more users.

Having 3 different models, as suggested by Janina, would be virtually impossible, financially. As you pointed out, all 3 models would have to go through the FDA, making the development phase even more expensive. And on top of that, having 3 diffrent size reservoirs, 3 different size cases, and 3 different production runs, would make them MUCH MORE expensive than simply having 3 fill sensors.

Brad, I can’t remember anymore, is the “Low Reservoir” alert level user selectable? If a wearable/disposable pump with 3 sensors is ever designed, that could be the solution for people who use less insulin not having to hear that alert for 3 days.

6

Hi Janine,
Nice to meet you and no apologies needed. I appreciate your ideas. That’s how we learn and try to improve future products, as I’ve moved on from Insulet to a different diabetes medical device start-up company.
I responded to some of your suggestions below on my reply to Brad.
Cheers,
Gil

7

The reservoir amount says “50+” until you reach the 50 mark, then it begins counting down. You can make the alert/alarm user dependent though, so it could remind you at 50 u, 25 u, etc. The lowest you set it is 10 u, so some modification would need to be done if one were developed for such a small amount of insulin (such as the 15 total units which Janina is currently using). I agree that the lower reservoir alert changes could help w/ a future device though!

8

Thanks for refreshing my mind!

So the Insulet pod already has 2 sensors. One for “filled/wake-up” at the 85 U position and one for “level” at the 50 U position as the insulin is used.

A more inclusive product could have 3 (instead of 2) sensors at postions 25U (filled/wake-up), 50U (level) and 75U (level). This means that, depending on how much insulin is put in, at first the system would say “25+”, “50+” or “75+” and as insulin is used, it would count each unit starting at 25U, 50 or 75U, respectively. In addition, the user selection for “Low Reservoir” alert could offer more resolution, at every 5 U from 5 to 50 U.

This only requires one extra "level"sensor. The rest of the changes are in software. Interesting… Thanks!

9

Another thing that would be nice to have… but probably also too expensive… would be different cannula lengths… I hear Omnipod just went with a “middle ground” that would work for most kids and most adults… It would be nice for my son if they had a version w/ a bit longer of a canula… he has some scar tissue from when he was heavier on his stomach… stretch marks… that aren’t that deep…but can cause problems if he hits one w/ the current cannula length of the Omnipod. In a perfect world…lol… I would want to be able to order what cannula size best suited my son… like you can w/infusion sets.

10

Would it be possible for a cannula that is longer to be cut to an appropriate length before being used?
When they choose the length, they may be appealing to the majority of the market and when they already have you as a custoimer, you are a captive market, so I can understand your frustration.
I’ve never had a cannula in my hand, so I don’t know how they work or how they are made, but is there logic in this…that if they made them longer and they could be trimmed shorter, wouldn’t that make the market larger and please more customers?
Here is what I just learned from a pharmacist yesterday…that there is a reason why injecting deep into muscle is more effective for some medications…the drug gets to the blood supply faster than if it is injected into fat where there may be limited blood flow. In that case you have to wait for the drug to seep through the fat cells, mabe between them until it gets to the blood flow.
We all know, from logic that if you inject into a vein, that the drug takes effect pretty quickly. Of course arteries are outgoing from the heart to the body and veins are returning blood flow, but I don’t know how to differentiate although colour is a factor.
This came up because I was having a discussion with a pharmacist about my annoyance that it is conventional for doctors to inject 1cc of B12 deep into muscle and I told him I felt strongly that it makes more sense to inject into fat three times a day a much smaller amount, like we do with insulin.
I also mentioned that I heard on a show that Anna Nicole Smith’s rear end was somewhat “wooden” (from autopsy report) because of the number of injections she had had there. I know from my own experience that very small injections of B vitamins or even insulin have never caused me to have lumps, until I did some injections of B vitamins several times over many days of 40u per injection. Then I did develop lumps, so stopped and remembered that my endo has often asked if I have any lumps. I guess other people do get them from large injections.
I do know that veins can become scared if they have been used so may times for injecting something or withdrawing blood. I have not had blood drawn for tests that much, but it has been 30 years.
So how about you ask the company about making a longer cannula that could be cut shorter. They might object and say they have to cater to the largest part of the market and don’t want to annoy people by making it necessary for them to be cutting things shorter…then make two sizes, and just produce them with two different production runs.
One thing about a small decision on that is that I hope it doesn’t require Lengthy FDA approval for every minor product improvement like adding a variety of sizes to cannula production

11

The cannula is internal to the pod before insertion. They would have to make different models with different cannula lengths. Or they would have to redesign the pod to allow for your suggestion. Unfortunately ALL companies’ decisions are made based on investment vs. potential return. So if it’s a small market they would probably choose not to do it.

12

This is an old topic, but the next omnipod due in 2012 can hold a minimum of 40U.
I think safer and better to use diluted insulin in pump: it's difficult (and dangerous) to do the math (the pump doesn't know you use diluted insulin) but pumping more "liquid" should prevent better cannula occlusions, and you can give finer doses.

The only approved diluent I know is the one for humalog, even if they warn not to use it in pumps (its use is not approved I think for stability fears, but they used it even for a 4 DAYS old baby girl link).

Cellnovo should have a "small reservoir" version about 50U, but has to actually still begin selling.

13

Thanks for this comment...I just discovered it tonight. Maybe if I wait long enough the cellnovo might become available in Ontario. My endo and I discussed the Omnipod 2 weeks ago, but I still thought it required twice the insulin I typically use. So now I feel there is hope. I did go to read that article about the baby. Interesting that they also mentioned transient diabetes.