News: "Insulin pumps linked to injuries, deaths in teens: FDA study"

[fgummett]

Just saw this on the CBC health news site...


Insulin pumps linked to injuries, deaths in teens: FDA study (http://www.cbc.ca/health/story/2008/05/05/insulin-pumps.html)

Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators in the U.S. finds.

Parents should be vigilant in watching their children's use of the pumps, researchers from the Food and Drug Administration wrote. They didn't advise against using the devices, but they called for more study to address safety concerns in teens and even younger children who use the popular pumps.

The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote.

Some teens didn't know how to use the pumps correctly, dropped them or didn't take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis.

"The FDA takes pediatric deaths seriously," said the agency's Dr. Judith Cope, lead author of the analysis. "Parental oversight and involvement are important. Certainly teenagers don't always consider the consequences."

The pumps are popular because they allow young people to live more normal lives, giving themselves insulin discreetly in public and getting pizza with friends late at night. And they're a growing segment of diabetes care, with $1.3 billion US in annual sales worldwide, said Kelly Close, a San Francisco-based editor of a patient newsletter. She said 100,000 teenagers may be using them.

The pumps are used for those with Type 1 diabetes, which accounts for between five and 10 per cent of all diabetes cases and used to be called "juvenile diabetes." The more common form is Type 2, which is often linked to obesity and more often affects adults.

Type 1 affects an estimated 12 million to 24 million people worldwide and occurs when the body attacks insulin-producing cells in the pancreas. Insulin regulates blood sugar levels which, when too high, can lead to heart disease, blindness and kidney damage.

Insulin pumps are the size of a cellphone and worn on a belt or pocket. They send insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place. They cost about $6,000 and supplies run $250 a month. Users must tell the device how much insulin to give before each meal, based on the estimated carbohydrates in the meal. The devices also deliver a continuous low level of insulin.

In the FDA study, appearing in the May issue of the journal Pediatrics, the reports of adverse events and deaths in adolescents using the pumps occurred from 1996 to 2005.

The FDA requires manufacturers to report injuries that could be linked to medical devices. The authors analyzed reports from patients 12 to 21 years old. They emphasized that the reports aren't always clear about the cause of death or injury.

The devices provide an alternative to multiple daily injections of insulin by syringe; some come with glucose monitors that reduce the number of times the finger must be pricked to test blood sugar.

While some teenagers want to switch from insulin injections to pump therapy to gain more flexibility in their lives, doctors said device problems such as a blocked tube can lead quickly to dangerous episodes of high blood sugar.

"In a matter of a few hours, all the insulin in the body disappears," said Dr. John Buse, the American Diabetes Association's president for medicine and science. "Metabolically, the child starts to spiral out of control.

"Kids need to be aware of the risk, monitor their blood sugar and be ready to give themselves an insulin injection."

[fgummett]

Here is the CTV take on the same report. I have highlighted the extra text at the bottom...

CTV.ca | FDA links insulin pumps to teen injuries, deaths (http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080505/insulin_teenagers_080505/20080505?hub=Health)

CHICAGO -- Insulin pumps are used by tens of thousands of teenagers worldwide with Type 1 diabetes, but they can be risky and have been linked to injuries and even deaths, a review by federal regulators in the U.S. finds.

Parents should be vigilant in watching their children's use of the pumps, researchers from the Food and Drug Administration wrote. They didn't advise against using the devices, but they called for more study to address safety concerns in teens and even younger children who use the popular pumps.

The federal review of use by young people over a decade found 13 deaths and more than 1,500 injuries connected with the pumps. At times, the devices malfunctioned, but other times, teens were careless or took risks, the study authors wrote.

Some teens didn't know how to use the pumps correctly, dropped them or didn't take good care of them. There were two possible suicide attempts by teens who gave themselves too much insulin, according to the analysis.

"The FDA takes pediatric deaths seriously," said the agency's Dr. Judith Cope, lead author of the analysis. "Parental oversight and involvement are important. Certainly teenagers don't always consider the consequences."

The pumps are popular because they allow young people to live more normal lives, giving themselves insulin discreetly in public and getting pizza with friends late at night. And they're a growing segment of diabetes care, with $1.3 billion in annual sales worldwide, said Kelly Close, a San Francisco-based editor of a patient newsletter. She said 100,000 teenagers may be using them.

The pumps are used for those with Type 1 diabetes, which accounts for betweem fove amd 10 per cent of all diabetes cases and used to be called "juvenile diabetes." The more common form is Type 2, which is often linked to obesity and more often affects adults.

Type 1 affects an estimated 12 million to 24 million people worldwide and occurs when the body attacks insulin-producing cells in the pancreas. Insulin regulates blood sugar levels, which when too high, can lead to heart disease, blindness and kidney damage.

Insulin pumps are the size of a cellphone and worn on a belt or pocket. They send insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place. They cost about $6,000 and supplies run $250 a month.

Users must tell the device how much insulin to give before each meal, based on the estimated carbohydrates in the meal. The devices also deliver a continuous low level of insulin.

In the FDA study, appearing in the May issue of the journal Pediatrics, the reports of adverse events and deaths in adolescents using the pumps occurred from 1996 to 2005.

The FDA requires manufacturers to report injuries that could be linked to medical devices. The authors analyzed reports from patients 12 to 21 years old. They emphasized that the reports aren't always clear about the cause of death or injury.

The devices provide an alternative to multiple daily injections of insulin by syringe; some come with glucose monitors that reduce the number of times the finger must be pricked to test blood sugar.

While some teenagers want to switch from insulin injections to pump therapy to gain more flexibility in their lives, doctors said device problems such as a blocked tube can lead quickly to dangerous episodes of high blood sugar.

"In a matter of a few hours, all the insulin in the body disappears," said Dr. John Buse, the American Diabetes Association's president for medicine and science. "Metabolically, the child starts to spiral out of control.

"Kids need to be aware of the risk, monitor their blood sugar and be ready to give themselves an insulin injection."

Dr. Christina Luedke, of Children's Hospital in Boston, said she carefully screens teenagers and their families before prescribing a pump. She has refused it for some young patients.

"Without appropriate glucose monitoring, the pumps can increase the risk of getting sick more quickly compared to injections," Luedke said. However, she said, proper use makes life more bearable and can improve glucose control.

Teenagers also have problems keeping their diabetes under control with multiple daily insulin injections, doctors and manufacturers said.

"It is a constant struggle for a patient who is an adolescent to stay in control of any therapy," said Steve Sabicer, a spokesman for Minneapolis-based Medtronic Inc., which makes the top-selling insulin pump.

The company stands behind the product's safety and "the many years of clinical evidence that support the benefits of insulin pump therapy," he said.


To put this in context I would like to see the figures for insulin abuse or death related to teenagers with type 1 using MDI

[morrisma]

Seems that teens and younger pump users aren't taking their disease (or their pump) seriously. No surprise with all the changes going on with that age group. Parents really need to stay on top of things and kids get very resistant to that intrusion. Probably right to withhold (or remove) pumps from those kids unwilling to let a responsible adult help.

[Eddy]

To put this in context I would like to see the figures for insulin abuse or death related to teenagers with type 1 using MDI


Exactly what I was going to say. Overdoses, be they accidental or deliberate, are just as simple with MDI. Yes, I've heard plenty of stories about CSII tubing problems... but might kids of self-conscious age be prone to skipping injections?

AFAICT, I'm lucky enough to have a nice, flat basal. Would a screwy-basal person really be better off with insulin mixes and timing? Probably not; someone such as Gary_W or xMenace is more fit than I to comment, though.

The article also fails to acknowledge the hybrid "untethered" approach: Use Lantus or Levemir to cover one's minimum basal, to keep some insulin in the system in case of CSII failure. I'd think that an agency "taking [something] very seriously" might have investigated that.

Pumps aren't perfect. Duh. They have risks. Duh. Some people might be better off using MDI. Duh. But this article strikes me (who is hardly known for being pro-pump) as biased and specious.

More tax dollars at waste.

[Gary_W]

It's a bit like saying that we should never allow a teenager to have toast because a breadknife is dangerous if mis-used. I agree fully with others that teenager related problems can occur with MDI or pumps.

I'm fortunate in that my diabetes had the decency to stay away until my teenage years were long gone. I'm glad I didn't have to go through that wonderful time again with the added bonus of BG control. With that in mind, I'm not fully equiped to comment as I haven't 'been there'.

What I do think is that pumping is not a magic bullet and that if a person (be they child, teenager or adult) does not get their head around how to use it and look after it, it will be a pretty expensive box of tricks that offers few benefits above MDI. For those that take the time, the benefits can be huge (depending on the individual and how well MDI suited them anyway...). Eddie's point about teenagers not wanting to inject in public is a good one. I must say that going out for a meal with work a week back and not having to say 'excuse me, just got to shoot up' was great, and I don't have confidence issues. Just the opposite for the most part :)

I do love reports like this one... 'Some people get hurt when self-administering a drug which can easily cause unconciousness (or worse) if you get it wrong'. Frankly with the level of education dished out at the same time as insulin I'm constantly amazed that more people don't shuffle off this mortal coil due to insulin misuse. At least MOST people given pumps are educated on their use / carb counting. If they had a report on how many people die from insulin misuse due to ignorance then I'd be interested. This report? Stating the obvious really.

Gary

[RobiJo]

To put this in context I would like to see the figures for insulin abuse or death related to teenagers with type 1 using MDI

If your a teen and do something wrong... it makes the news.

[Funnygrl]

Having read the whole article- I have no arguments with anything it said. It's point was that people have died from mis-using it. Even if people have mis-used shots, that's not the point. They're talking about pumps.

It says parents need to be viligent. Any arguments there?

It's saying that pumps are useful if used correctly- any arguments there?

It's saying that good diabetes management takes discipline and effort. I think we'll all agree to that.

[notme]

Having read the whole article- I have no arguments with anything it said. It's point was that people have died from mis-using it. Even if people have mis-used shots, that's not the point. They're talking about pumps.

It says parents need to be viligent. Any arguments there?

It's saying that pumps are useful if used correctly- any arguments there?

It's saying that good diabetes management takes discipline and effort. I think we'll all agree to that.

I certainly don't disagree with any of the points you have made here. Parents need to be vigilant if they have a child or teen with diabetes. I think this goes without saying and certainly doesn't pertain only to teens with pumps.

Pumps are useful and safe if used correctly but so are cars and chain saws.

I think it is the implication that pumps are the cause of the problem is the issue I have with this study and article.

Honestly, being a teen is the root cause of the problem and not a malfunctioning pump or a pump that dropped or used incorrectly. I think if a teen doesn't want to use a pump correctly, they probably won't use a needle or meter correctly either. ;)

[Jan B]

My mom mentioned that pumps were killing teenagers at lunch today (as I bolused at the table). I came home and read the articles . . . it's sad what some people take away from quick news briefs. By the way she said it, you'd think the pump was pre-programmed to "off" teens.

[condensr]

I have to agree that frequent BG monitoring be a prerequisite and staple of pump usage. (Of course, it should be for any person with diabetes, but this isn't about that.) When malfunctions occur that interrupt insulin flow, things DO get out of control quite quickly, especially for those type 1s who do not eat a carb-controlled diet (like me).

[BlueSky]

... Overdoses, be they accidental or deliberate, are just as simple with MDI. .....
I don't think the concern it overdosing. With a pump, delivery failure, lack of insulin and DKA are much bigger potential problems.

Presumably the 13 deaths were associated with DKA induced by inadequate insulin. I wonder what the nature of the 1,500 injuries was .... :confused:

[Eddy]

With a pump, delivery failure, lack of insulin and DKA are much bigger potential problems.


I agree. Hence why I wish { {bare-minimum basal shots} + { CSII } } would receive more mindshare. If I had to use a pump, I'd probably start by trying 60% of basal via Levemir.

I wonder if DKA risk is part of my pump aversion. My DKA experience was one that I wish to avoid repeating...

[Funnygrl]

I agree. Hence why I wish { {bare-minimum basal shots} + { CSII } } would receive more mindshare. If I had to use a pump, I'd probably start by trying 60% of basal via Levemir.

I wonder if DKA risk is part of my pump aversion. My DKA experience was one that I wish to avoid repeating...
If you're cautious with frequent testing, dka really isn't much of an issue.

[Eddy]

If you're cautious with frequent testing, dka really isn't much of an issue.



Overnight?
Weighing pros/cons of low-basal shots would be a personal choice.


If you know the way I structure ACLs (access control lists), source code, et cetera, it's no surprise that I'd take a "belt and suspenders" approach to pumping.

But... such is my biased take. Others do what works for them. :) I just thought there'd be more consideration of a hybrid approach.

[Eddy]

If you're cautious with frequent testing, dka really isn't much of an issue.


I also should add: Part of my bias stems from how quickly insulin finishes in me. Rapids (Novo and Lilly) in 1.5 hour or less, and human in 2.0 hours. How long can one "safely" go without basal insulin?

[Funnygrl]

Pumps have occlusion alarms that go off if something is blocked. The biggest problem I've ever had is pulling a set out in my sleep. The highest I've woken up from that is 290.

Even if you wake up 600, it sucks, but if you know what to do, you should be able to avoid dka.

Contrary to popular belief, dka isn't just high bg + ketones. You need to actually change your body's pH and start messing up your bicarb too. That takes a fair amount of time.

[Eddy]

(emphasis added to specify context)


Pumps have occlusion alarms that go off if something is blocked. The biggest problem I've ever had is pulling a set out in my sleep. The highest I've woken up from that is 290.


Good to know.


Even if you wake up 600, it sucks, but if you know what to do, you should be able to avoid dka.


Yes... although wouldn't that high be risking hyperosmolar coma?


Contrary to popular belief, dka isn't just high bg + ketones. You need to actually change your body's pH and start messing up your bicarb too. That takes a fair amount of time.


Ahhhh.... that is what I wanted to know. It seemed logical enough -- after all, it clearly took me a while to DKA when I was pre-DX and totally untreated. However, I don't know if I have progressed since then; i.e., I have no idea how quickly things would get ugly if I went without basal. I really don't care to test, either.

Thanks!

[Funnygrl]

Yes... although wouldn't that high be risking hyperosmolar coma?
Not really. That takes a long time to develop too. Even longer than dka often. Those people have really high bgs- like 900+. It takes a ton of glucose to alter the osmolarity of your blood. I'd even dare to say you need kidney damage, as your kidneys can excrete some glucose even in the absence of insulin. In clinical practice, I've seen HHNK once and DKA a handful of times. The HHNK was a man who hadn't taken anything for his diabetes for several months. The DKA's were all girls who hadn't taken their insulin for a few days or were taking less than they were suppose to("I forgot to fill it").

I really don't care to test, either.

Good plan.

All in all though, if you feel that you need background levemir, there's plenty of evidence to suggest that that's a good, effective plan as well (a la untethered regimen).

[solox316]

By the way she said it, you'd think the pump was pre-programmed to "off" teens.

Ok, I know I shouldn't have... But this quote made me seriously laugh out loud. :eek:

[duck]

Ok, I know I shouldn't have... But this quote made me seriously laugh out loud. :eek:

Me too, this disease can jade you sometimes.

[kates mom]

My daughter almost died because of her MM pump malfunctioning. It said it was giving her insulin when it wasn't. Has anyone else experienced this? It happened Jan of 2002

[Jan B]

My daughter almost died because of her MM pump malfunctioning. It said it was giving her insulin when it wasn't. Has anyone else experienced this? It happened Jan of 2002

Hi Kate's mom and WELCOME. I'm so glad your daughter is ok. I have a cousin who ended up in the hospital for the same reason you mentioned.

When I get high, I feel bad, and immediately check my bg and bolus if I need to. Then I always check again in an hour or so to make sure insulin is getting to me. If I'm higher than I think I should be, I change sets (check to make sure cannula isn't bent). (I took lousy care of myself as a teenager and probably would not have verified cannulas were really in, etc.) Nowadays I check bg often and never believe the pump is 100% perfect. So far I've not seen the pump malfunction but I've had to change sets when the cannula is bent & obviously there is no way for a pump to tell you the cannula is bent.

Did you have a true MM malfunction or was the cannula bent?

[Funnygrl]

My daughter almost died because of her MM pump malfunctioning. It said it was giving her insulin when it wasn't. Has anyone else experienced this? It happened Jan of 2002
I'm glad she's ok.

How often was she testing? I'm guessing it would have become obvious her blood sugar was going up after awhile. Were you instructed to correct via injection if pump corrections weren't working? Were you in contact with MM's customer support and your endo office during this?

Did she end up deciding to go back on the pump?

[kates mom]

It was a true malfunction. They even wrote it on the hospital papers. She is now 17. We have always checked BS at least 6 times a day. It took 2 hospitals and a life flight to figure out what was wrong. She had water on the brain as a result of all of the fluids she was given. It was terrible. I just wondered if this had happened to anyone else. We are getting ready to go back to shots. She now has the 712 and before it was the 508. The rep said sometimes static can cause problems with the pump.

[Funnygrl]

I'm still a little confused, so just bear with me.

You said it took 2 hospitals to figure out what was wrong. At no point no one took a blood sugar, realized it was high, and started insulin via an IV?

[kates mom]

Oh, they did but she was 10 years old and children can go critical as quick as they can rebound back. At first they thought she had the flu..causing everything else to go out of wack. Every test possible was run on her. When they did blood gases that is when they life flighted her. She had fluid on the brain and they were thinking encephalitis.

[Funnygrl]

How scary, I'm gald she's ok.

[Gary_W]

I too am glad she is OK.

I'm amazed that static could cause a problem like this in the modern world.

Before I started selling medical equipment for a living, I used to fix it. Back then, I used to repair everything patient-related in the local hospital from defibs through infusion pumps. There was a pump 15 years ago (a general infusion driver for the hospital environment, not an insulin pump) that was affected by static, but when it was affected in this manner it would go to an alarm state. Once this was brought to the attention of the company in question via the Medical Devices Agency (a govt. body that deals with the safety of medical equipment) the company put out a warning notice to all users and set about modifying all the pumps so as the problem would no longer occur. The modification involved swapping out the control panel as (if a user was highly charged from a static point of view due to nylon clothing or whatever) the static could jump through the button membranes and affect the pump. The swapout fixed the problem. But bear in mind that even before this happened the pump failed in a SAFE MANNER; it did not over-infuse the patient and it gave an alarm so the user could decide what to do.

All pumps made these days have multiple interlocks and saftey features on them which ensure that, if a device fails, it fails in a safe way. That safe way may be 'no delivery' but it's safer than 'give the whole cartridge at once' for example. I'm afraid I cannot believe that the MM could fail due to 'static' and not tell you it had done so. It performs an awful lot of self checks every minute and if one of the checksums doesn't add up it will soon tell you that it isn't happy.

A big IMO here, but... The static problem told to you sounds like an off the cuff remark from a very dumb rep. If there was a genuine static problem with MM pumps, a rep certainly would not tell an end user whose daughter had suffered illness which may result in a lawsuit. Indeed, the company would be duty bound to inform the US version of the Medical Devices Agency (there will be one) and they in turn would take action. This action would be anything between a warning letter to end users, possible modification or total recall of the products. Not trying to be offensive, as I daresay this comment was said to you in good faith and obviously I only know the bits of the story you've posted here. But from my knowledge of the industry, such a dangerous fault would be dealt with in a manner other than a rep making a comment.

Gary

[Funnygrl]

I'm amazed that static could cause a problem like this in the modern world.
...

A big IMO here, but... The static problem told to you sounds like an off the cuff remark from a very dumb rep.


Static was actually a well known issue with the 50x series, but has since been addressed. They recommended 50x users use the leather case to avoid some of the issues.

[Gary_W]

Static was actually a well known issue with the 50x series, but has since been addressed. They recommended 50x users use the leather case to avoid some of the issues.

Thanks for the info; I am hopeful that it 'failed safe' (or as safe as a pump can fail...) because telling people to use a leather case to fix it really isn't on...

[solox316]

Static was actually a well known issue with the 50x series, but has since been addressed. They recommended 50x users use the leather case to avoid some of the issues.

I went through 2 (had 3 total) 507c/8 pumps, for that same reason! Glad they worked out that "minor" glitch in the new ones...

[notme]

I am too Scott. I had two 508's that were wrecked by static. My 715 has no case and no static issues. That was a huge plus for me. I hated the leather cases.