On the Edges of Science and Law

Blood Glucose Monitors: A Sleek 21st Century Look With Nixon Era Accuracy

 GUEST BLOGGER Ed Kraus

It is essential that people with diabetes have accurate tools with which they can effectively manage their disease on a day-to-day basis.  And, despite all the recent technological and scientific advances in diabetes management, it appears that home blood glucose monitors—one of the most commonly used and critical tools for the management of glucose levels—are not keeping pace with the times.  

In a July 2009 New York Times article, Gardiner Harris wrote that the Food and Drug Administration (FDA) is considering tightening its accuracy standards for home blood glucose monitors (BGMs).  The article highlights the fact that the FDA has long followed international standards set by the International Organization for Standardization (ISO) which allow for BGMs to be manufactured with an error rate of up to 20%.  While an error rate of 20% may have seemed acceptable or reasonable 10 years ago, given our present-day technology and our current understanding of the clear health benefits of tight control of glucose levels, it is simply indefensible.

To understand why this error rate is unacceptable, it is helpful to consider what a 20% error rate for a BGM actually means for an individual with diabetes.  Let's take the example of an individual who checks her glucose level and gets a reading of 156 when, in fact, her blood glucose is only 130.  With a reading of 156, she might administer a correction dose of insulin to lower her glucose to a level within her target range.  However, had the BGM accurately displayed her glucose level as 130, she would not have taken any insulin.  This unnecessary dose of insulin could then cause her glucose levels to go too low -- meaning below the low end of her target range -- and cause her to suffer from hypoglycemia.  Alternatively, if her blood glucose level was actually 160 but the BGM gave a reading of 128, she might not administer any insulin -- because she might falsely believe that her glucose level is within her target range.  Failing to administer insulin when it is needed could lead her to becoming hyperglycemic which, over time, can cause serious health complications. 

As it turns out, in response to concerns from the American Association of Clinical Endocrinologists regarding BGMs' accuracy, in June 2009, the FDA pressed the ISO to tighten its standards.  In addition, the FDA has indicated that if the ISO does not act, the FDA will take the initiative itself by requiring higher performance standards for BGMs sold in the United States.  However, as of September 2009, the FDA has yet to do so; rather, it appears that the FDA is still merely commenting on its plans to make changes in some way or another.

It is interesting to consider why there have not been any major improvements in the accuracy of BGMs in the past decade.  BGM manufacturers have improved the technology, aesthetics, and convenience of BGMs since their introduction in the 1970s, but manufacturers have not improved the accuracy of glucose level readings -- arguably the single most important feature of a BGM.  As FDA Commissioner Margaret Hamburg has indicated, this is the result of manufacturers' contentment with meeting the international standard set by the ISO.  But this response begs the question: Why have market forces led BGM manufacturers to improve certain aspects of their products, but not accuracy? After all, most people with diabetes purchase and use BGMs with the goal of closely managing and monitoring their glucose levels, which in turn enables them to minimize the risks of long-term, diabetes-related complications.  Perhaps BGM manufacturers have taken advantage of the fact that individuals easily notice the aesthetic difference between certain BGMs, but that most BGM users likely were never (or still aren't) aware of the 20% error rate allowed by the FDA?

Whatever the reason for the market's failure to promote the development of more accurate BGMs, the solution is clear.  Whether by pressuring the ISO or creating its own higher standards for domestic BGM approval, the FDA should act quickly and decisively to put an end to the current tolerance of a 20% error rate for BGMs. 

Ed Kraus is an Associate Clinical Professor at Chicago-Kent College of Law.  Professor Kraus focuses part of his practice on representing and advocating for individuals with diabetes in education, employment and insurance matters.

"What if our perception of normal exposure is skewed?": Analyzing the Science of BPA

by Sarah Blenner

Bisphenol A (BPA) is an estrogen mimicking chemical commonly used to create both polycarbonate plastics and the resin lining of cans.  This chemical can be found in plastic food and beverage containers, cans, dental sealants, household products, cell phones, computers, and medical devices.  Hundreds of studies link the synthetic hormone, BPA, to a variety of adverse health conditions, including, breast cancer, prostate cancer, ADHD, autism, obesity, insulin resistance, type 2 diabetes, liver enzyme abnormalities, early onset of puberty, and cardiovascular disease.

In a study conducted by the CDC, scientists found that BPA was present in 93% of Americans tested, signifying the high prevalence of BPA exposure in the American population.  One participant of the "Is It In Us?" study, which measured the presence of toxic chemicals, such as BPA, in the blood and urine of participants, was relieved to know that her results were no different than the results of most of the other participants.  But then she thought: "what if our perception of normal exposure […] is skewed?" 

Last May, Chicago became the third jurisdiction in the United States to successfully pass legislation regarding Bisphenol A when it banned the sale of baby bottles and other empty food and liquid receptacles intended for the use by children under the age of three.  Prior to Chicago City Council's passage of the BPA Free Kids Ordinance, the State of Minnesota and Suffolk County New York passed legislation regulating BPA.  In June, Connecticut became the fourth jurisdiction in the United States to address the health risks of BPA through legislation, when it passed an "Act Concerning Banning Bisphenol-A in Children's Products and Food Products."  According to the Public Act, beginning October 1, 2011, the sale of infant formula, baby food, and reusable food or beverage containers that contain the chemical Bisphenol A will be banned. 

Judge Sotomayor

By Julie Burger

The headline of a recent Time Magazine story about President Obama's U.S. Supreme Court nominee asked, Sotomayor's Diabetes:  Will it Be a Handicap?

The authors seem to be asking whether Judge Sotomayor's type 1 diabetes will be an impediment to her confirmation.  Although many news stories about Judge Sotomayor mention that she was diagnosed with the disease at age 8, most commentators and experts believe that the disease will not negatively impact her ability to be a justice on the Supreme Court.  The disease is serious, raising the risk of heart disease, blindness, amputation, and kidney problems.  And yet, if well-controlled, people with diabetes can live long and productive lives.  There is no reason Judge Sotomayor's diabetes should prevent her from being qualified to sit on the Supreme Court.

Wheels of Justice Grind Slowly for Havasupai Tribe

By Julie Burger

In a remote section of the Grand Canyon about 450 members of the Havasupai Tribe live on tribal lands where they have lived for hundreds of years.  Another 200 members of the Tribe live away from Supai, the village area.  In March of 1990, researchers from Arizona State University ("ASU") (Drs. Theresa Markow and John Martin) presented the Havasupai Tribal Council with a proposed diabetes study, saying that they would like to collect and use tribe members' blood for diabetes studies.  The researchers met several times with the Tribal Council, but according to allegations, never revealed they intended to perform research other than diabetes research.  With the Council's approval, blood samples were collected from members of the Tribe, including children and vulnerable people.  Researchers additionally took handprints from members.  English is not the tribal members' primary language and many members do not even speak English as a second language.

The researchers did not stop at diabetes research.  They also performed additional research on the samples for schizophrenia, inbreeding, and population migration, and shared the samples with researchers at other institutions.  After discovering the additional research, the Havasupai filed state court complaints on behalf of individual Tribal members and on behalf of the Tribe against ASU and the researchers in 2004.  The Havasupai maintain that the schizophrenia and inbreeding research was stigmatizing and that they would not have consented to the migration research because it conflicts with their religious origin theory.  A member of the Tribe points out that "[the researchers] challenged our identity and our origins with our own blood and without telling us what they were doing."

Chicago Takes A Stand: City Council Committee Unanimously Votes in Support of the BPA-Free Kids Ordinance

GUEST BLOGGER Sarah Blenner

Bisphenol A (BPA), the controversial, toxic chemical found in many plastic food containers, is once again making headlines.  BPA is an estrogen-mimicking chemical that is used to make polycarbonate plastics.  Hundreds of studies have linked BPA to a variety of adverse health conditions, such as diabetes, insulin dependency, obesity, breast cancer, prostate cancer, hyperactivity, ADHD, autism, early onset of puberty, cardiovascular disease and liver enzyme abnormalities.

In January, Julie Burger argued that "the time to act is now."  Leading scientists state that the potential health risks of BPA are too significant and the FDA's determination that BPA is "safe" is simply the chemical industry's creation of "manufactured doubt."  With hundreds of studies linking BPA to adverse health conditions, the FDA relied solely on a limited number of studies funded by the chemical industry that showed "no harm."

In These Tough Times, Young Children Provide Health Care for Parents and Grandparents

By Tim Welch

As the incidence of chronic conditions such as diabetes increases across the nation (in 2007, there were 1.6 million new cases of diabetes diagnosed in people aged 20 years or older), more Americans are requiring long-term medical care.  Couple that with an economic recession that has millions of workers unemployed, without income or insurance, and unable to pay expensive hospital bills, and you have a serious health care crisis.  A recent article published in The New York Times described how the pressures of this crisis are frequently falling on the shoulders of American children.  As parents and grandparents are increasingly unable to foot the bill for medical care, children aged 8-18 are assuming the caregiver role.

According to the article, children across the country are being asked to perform various tasks often becoming of professional nurses, including, but not limited to, "lifting frail bodies off beds or toilets, managing medication [including injections], washing, feeding, dressing, and talking with doctors." 

New Technology for Administering Glucagon Could Assuage Schools' Fears, Save Children's Lives

By Tim Welch

Many kids with diabetes are having serious problems at school when it comes to potential emergency situations.  One of the issues that children and adults with diabetes face is the risk of severe hypoglycemia.  Severe hypoglycemia occurs when the body's blood sugar level gets too low.  It is an extremely dangerous and life-threatening condition, in which the body begins to shut down.  Without immediate treatment, the hypoglycemic person will lose consciousness and stop breathing.  If left untreated, the condition will lead to coma, brain damage, and death.

In a severe hypoglycemic emergency, the person may not be capable of swallowing food or liquids and cannot eat food or drink beverages to raise their blood sugar.  But fortunately there is a life-saving treatment.  Glucagon, a hormone that causes the liver to release glucose into the blood stream, can be administered to help the person who is suffering from hypoglycemia.  It is crucial that glucagon be administered immediately in order to save the hypoglycemic person's life.  Administering glucagon is also relatively low-risk, since it is safe to inject even if the person with diabetes is not suffering from hypoglycemia, but some other condition with similar symptoms.

School Children with Diabetes: Study Finds Better Control with Higher Self-Responsibility

GUEST BLOGGER Keith Syverson

Surveys have shown that the vast majority of teachers know of at least one student in their school with a chronic illness.  Several studies have investigated the administration of medication in schools from the perspectives of principals or of school nurses, but few studies exist on how students and parents feel about this issue.  A 2008 study in the Journal of School Nursing went directly to the source, interviewing students with diabetes, asthma, and ADHD in order to determine the "types of problems and mistakes [they] experience with their medicines at school."  The group of researchers included pharmacologists and a professor of nursing.  They reached conclusions that surprised them but correspond to modern recommendations for diabetes care.

The researchers initially assumed that the higher the level of responsibility a student has for his or her medication administration, the greater the child's "risk factor index" and the greater the chance of medication error.  The authors state that this index is a combination of risk factors previously identified in the literature and "the collective clinical experiences of the authors."  These included whether the child: transports his or her own medication to school, stores his or her own medication within reach, and whether the child self-administers his or her own medication.  The researchers found that students with diabetes have the highest degree of self-responsibility and thus, as a group, have the highest risk factor index.  Contrary to the initial assumption that a high degree of self-responsibility put the student at a high risk for medication errors, the researchers found that diabetic students had the lowest prevalence of medication error. In contrast, a higher prevalence of errors was reported among children with ADHD who had the least amount of self care responsibility.

Oops, That Wasn't a Cell Phone, It Was His Substitute Pancreas

GUEST BLOGGER Sarah Blenner

As Clifton Hassam, a Florida 16 year old junior in high school, sat in class, his blood sugar began to reach dangerous levels.  His monitor, which is attached to his hip, began beeping to inform him of this.  Hassam reached down to turn off the beeping noise and take care of his blood sugar levels.  However, the substitute teacher, believing that Hassam had a cell phone, the use of which during the school day is forbidden, reached down and grabbed the device, pulling out the tubing from Hassam's waist and disconnecting the insulin pump.  It took several days before Hassam's blood sugar reached normal levels again.

Hassam was diagnosed with diabetes when he was six years old.  Like many other individuals with type-1 diabetes, Hassam manages his diabetes in part by wearing an insulin pump, a device that is designed to notify Hassam when his blood sugar reaches unhealthy levels.  According to Hassam, the pump is “my whole life on my side.” The device is about the size of a pager and has a tube (or catheter) that runs under the skin and into the blood stream.  The pump not only monitors blood glucose levels, but it also releases fast acting insulin directly into the blood stream just as a pancreas in a body with normal pancreas function would release insulin into the blood stream.

Nanotechnology Could Make Blood Glucose Monitoring Less of a Pain

By Jake Meyer

In our lifetime, we may see nanotechnology offer improvements in nearly every facet of modern life.  The field of medicine is no exception and nanotechnology research looks to provide technology breakthroughs that will change the way diseases are treated.  Nanotechnology has the potential to improve the treatment of malignant diseases like cancer.  For example, U.S. Patent No. 6,727,065 describes a quantum dot which attaches itself to a cancerous tumor and upon exposure to infrared radiation releases a substance toxic to the tumor.  Nanotechnology also has the potential to improve the treatment of chronic diseases such as diabetes.  Diabetes affects millions of Americans and recent nanotechnology research may lead to a new way of monitoring blood glucose that doesn't involve sticking yourself with a needle.

Researchers at Purdue University have created a biosensor which precisely detects blood glucose.  The biosensor is composed of a single-wall carbon nanotube attached to a gold-coated "nanocube."  The nanocube acts as a sensor and the carbon nanotube acts as a wire to carry electrical signals to electronic circuitry.  The design has been referred to as a tether ball and is well-suited for sensing applications because the sensing portion of the system extends out from the rest of the system allowing it to contact target molecules more easily.  Attached to the nanocube is an enzyme called glucose oxidase.  When the enzyme is in the presence of glucose and oxygen there is an electrochemical reaction that generates an electrical signal, which then travels along the carbon nanotube.