Insulin Pumps Linked to Injuries, DeathsMay 5, 2008 | Parker Waichman LLP
A review by the US Food and Drug Administration (FDA) just revealed that insulin pumps can be risky and have been linked to injuries and deaths. Insulin pumps are generally used by teenagers with Type I diabetes and the FDA, while not suggesting parents find alternate treatments, suggest they exercise increased vigilance. The FDA is also calling for additional studies to review and respond to safety issues in teenagers and children using insulin pumps.
Type 1—juvenile—diabetes comprises between five and 10 percent of all diabetes cases, affecting 12 to 24 million people globally and involves the body attacking insulin-producing cells in the pancreas. Type 2 diabetes is far more common, usually affects adults, and is generally linked to obesity. Insulin regulates blood sugar levels and if blood sugar levels go too high, heart disease, blindness, and kidney damage can result.
The insulin pump was developed for Type 1 diabetes patients and is popular because it allows patients to dose themselves, as needed, discreetly and in public. Pumps give patients an alternative to multiple daily injections and some may include a glucose monitor, which reduces blood sugar testing by pricking a finger. It’s estimated about 100,000 teenagers may be using insulin pumps globally.
The federal study reviewed use of the insulin pumps over the course of the decade from 1996 to 2005 and revealed 13 deaths and over 1,500 injuries based on reports from patients aged 12 to 21. Some of the problems were related to insulin pump malfunction and others due to carelessness or risk-taking by the patient. Device problems such as a blocked tube can quickly cause dangerous high blood sugar levels. "In a matter of a few hours, all the insulin in the body disappears. Metabolically, the child starts to spiral out of control," said Dr. John Buse, the American Diabetes Association's president for medicine and science, adding that patients need to be aware of the pump’s risks, monitor their sugar levels, and inject themselves, if needed
Some of the teenagers studied did not understand how to correctly use the insulin pumps, had dropped the pumps, or were negligent in their care of the devices. At least two possible suicide attempts were made by teenagers who overdosed themselves with insulin. Reports were not always clear about cause of death or injury. The study is published in the May issue of the journal Pediatrics.
Insulin pumps are about the size of a mobile phone and can be worn on a belt or pocket. The pump deploys the insulin into the body through a plastic tube with a small tip that inserts under the skin and is taped in place. Insulin pumps cost about $6,000 and related supplies cost an additional $250 a month; most insurers cover the bulk of the cost. Devices deliver a continuous low level of insulin and patients also tell the device how much insulin to dose before each meal, based on the meal’s estimated carbohydrates,
"Without appropriate glucose monitoring, the pumps can increase the risk of getting sick more quickly compared to injections," Dr. Christina Luedke of Children's Hospital Boston, said.