[fgummett]

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

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

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

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]

Originally Posted by fgummett

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]

Originally Posted by fgummett

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]

Originally Posted by 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.

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]

Originally Posted by Eddy

... 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 ....

[Eddy]

Originally Posted by BlueSky

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]

Originally Posted by Eddy

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]

Originally Posted by Funnygrl

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

1. Overnight?
2. 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]

Originally Posted by Funnygrl

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?