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AACE Patient Safety - News

AACE Calls For New Standards for Safer Insulin Pump Use

2008-05-24 15:56:18
By: Richard Hellman, MD, FACP, FACE

JACKSONVILLE, FL - "The American Association of Clinical Endocrinologists applauds the FDA's efforts to protect the safety of children and adolescents who are using insulin pumps," said Dr. Richard Hellman, the Association's President.

In the May edition of Pediatrics, Dr. Judith Cope, a physician at the FDA, provided new data that shows there is a serious problem regarding patient safety in insulin pump use. She reported data on 1594 injuries and 13 deaths in children and adolescents collected over 10 years. 82% of the cases resulted in hospitalization. The most common single issue was lack of education and, neither the patient nor the responsible adult knew enough about how the pump worked to avoid the injury or death that resulted. Although there were some cases due to mechanical malfunction of the pump, most problems were the result of human factors involved in the use of the pumps.

Unfortunately, the FDA has not yet provided similar data regarding the numbers of serious injuries in the larger group of pump users, adults who are using insulin pumps. This data, which is critically important, is very difficult to obtain and only the FDA is likely to have the ability to have access to the data of injuries and deaths from all of the manufacturers of insulin pumps.

There is every reason to be concerned that the data from insulin pump use in adults will also indicate a significant number of injuries and deaths similar to those found in the pediatric study. "The factors noted in the pediatric study that contributed to poor outcomes in children and adolescents can be expected to be present in a significant proportion of the adult population on insulin pumps," said Dr. Hellman.

Limited access to education at the time of initiation of pump therapy was a common problem in children and adolescents. It may be even more of a problem in adults. So is the lack of availability of support for pump use in emergencies. Many physicians and their staff who care for patients on insulin pumps are not sufficiently knowledgeable about the pump's performance to be able to troubleshoot when the patient makes a mistake or the pump malfunctions. Although telephone support is usually available from the manufacturer: the support personnel are neither the prescribers of the insulin doses nor directly involved in the patient's care.

In addition, as inadequate insurance coverage for adults becomes more common, new barriers to continuing care develop. Moreover, many new pumps are very sophisticated and complex, and their complexity can overwhelm even experienced users, and greatly increase the risk of error in patients who are inexperienced with pumps, or distracted, anxious, depressed, or having any transient cognitive problems as often occurs with either severely low or high blood glucose levels.

Dr. Hellman said that the American Association of Clinical Endocrinologists has an annual program, now in its third year, to teach and provide hands-on experience to all physicians completing specialized training in endocrinology. They are taught how to care for patients on insulin pumps, how to protect them from harm due to pump malfunction, and how to improve their patient's skills in using an insulin pump safely and well. The physicians find the program most valuable, but more such programs are needed. "This past year we appointed a task force of pump experts to develop guidelines and standards for initiating pump use and what we consider essential to provide for the safe and effective medical care of those on insulin pumps."

The American Association of Clinical Endocrinologists is very supportive of insulin pump technology and believes more patients can benefit from these pumps. But it is also clear that there are a significant number of patients who should not have been placed on these pumps. Dr. Hellman said, "These include patients with severe emotional problems that distract them from their safe self-care, as well as patients who cannot deal with the complexity of the pumps, suffer cognitive overload as a result, and do poorly. Most patients need more education and informed medical support, and nearly all do better in an integrated program that coordinates their diabetic care. But a continuing problem is that the education, both initial and continuing, and the medical support to deal with the specific problems and needs of pump users, is neither being provided nor paid for. As a result, we have a patient safety problem that may not be the pump itself, but a systems problem, that is, a failure of the system of care for pump support. The FDA needs to obtain the safety data on insulin pumps and share it with the scientific community as soon as possible. We need to move forward to make insulin pump use safer, and allow for the elimination of the deaths and injuries in pump use as those reported by Dr. Cope and the FDA team."

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There are 3 comments

Shashank R Joshi – India

August 27, 2008 - 14:51

Subject: Byetta and Pancreatitis-Practical Issues

Byetta and Pancreatitis - An Indian View
-- Dr. Shashank R Joshi, MD, DM, FACE, FRCP(Glg)
Endocrinologist, Mumbai India
Hon Editor, Journal of The Association of Physicians of India
Chair, Indian Chapter of AACE

Both your bezoar case and pancreatopathy make good reading. Incidentally, I reviewed global literature of all agents of diabetes and their impact on the pancreas. All secretagogues, as well as glinides, have case reports of pancreatitis reported. However, cause-effect relationship has never been proven, both in animal studies as well as reported anecdotes. In fact, the global reportage of pancreatitis is so small statistically that most cases had some other etiology for pancreatic injury. So currently we do not have sufficient evidence for pancreatic injury due to exenatide, but it stands to reason that in a predisposed individual it may act as a potential trigger for pancreatic injury.

The real worry will be the ongoing LAR preparation which is now under phase 3 trial program

Exenatide has some evidence to suggest that it may trigger a cholinergic response in alcoholics and that could be a beeptive pathway for pancreatic injury

So clinically, exenatide needs the following caveats prior to its use:
1) Chronic alcoholics or abuse
2) Refractory GERD
3) History of acute or chronic pancreatitis
4) Gall stones
5) Gastroparesis

One should avoid or exercise caution to use it in the above stated indications. Our institution avoids byetta in the above mentioned indications till further data will emerge

In India to date, one case of pancreatitis is reported.

Richard Hellman MD – NKC,

August 26, 2008 - 11:06

Subject: Byetta and stomach pain

Dear J.A. Moore,

Your question about Byetta and your nightly pain, which your doctor says is from your stomach, is a very important one, and thank you for asking it. It is not clear as to whether you are free of abdominal pain at this time. If you are pain free at this time, it may be difficult to be sure as to why you had pain in the past. If you are still having nightly pain, then my comments may be more relevant. Since I am not your doctor, I do not know enough about you to make a diagnosis or offer therapy, but I hope I can be helpful in some general suggestions. As we get older, the risk that a pain in the abdomen is a serious medical condition increases. But resistant pain in the abdomen can be from many causes: infections, such as a H.Pylori infection of the stomach, inflammation, such as pancreatitis, or a disease of the intestine called Crohn's disease, motility problems, such as gastroparesis, and other possibilities, vascular problems such as abdominal aneurysms, and also tumors, such as cancers of the stomach and of the pancreas. But there are other, much more common and simple problems, such as irritability of the gastrointestinal tract either due to drugs, such as metformin, or conditions as irritable bowel syndrome. I certainly could not tell from what you have said whether your problem is any of the above, or whether it is or was related to byetta.

But I think your questions are right-on and you should find out why you have had pain and whether it has anything to do with either byetta or to metformin. Your doctor should be able to do some screening tests for pancreatitis, and gastroenterologists can answer other of your questions, but I would encourage you to proceed to ask your health providers to answer your excellent questions.

You should also note that in the editorial I wrote on byetta, I discussed the responsibility of doctors to answer questions of this type. Thank you again for your excellent question. I hope I have been helpful.

J.A. MOORE – Washington DC

August 25, 2008 - 13:47

Subject: Byette

I have been taking Byette and have a nightly pain which the Dr says is my stomach. I am overweight and have high triglycerides. The Drs ran all kinds of tests on my gall bladder xrays plus other tests....including nuclear meds test. Gall bladder tests turned up negative. Then the Gastro Drs said it must be the valve on the stomach that's weak on diabetics and they gave me some medicine that kept me going to the toliet. I quit the medicine after almost a week of torture. But I took 3-Omega Oils capsules 3 times a day and Liptor and Tricore. My lipids were tested two weeks ago and the pain is gone and my Lipids very low in normal range with one type being under the allowable rate but my Endo Dr said that was OK. SHOULD I WORRY THAT I may have or had pancreatitis? I am still taking the Byette plus Metformin and Lantus..