What's the “buzz” on diabetes?

The American Diabetes Association (ADA) now recommends the HbA1c assay to diagnose and screen for diabetes and pre-diabetes, giving the test a prominent role in its Standards of Medical Care in Diabetes—2010. HbA1c has several advantages over traditional fasting plasma-glucose and glucose-tolerance tests: greater convenience, since fasting is not required; improved preanalytical stability; and fewer day-to-day variations caused by illness and stress. Early diagnosis of diabetes allows physicians to treat patients sooner and reduce life-threatening complications such as kidney failure. One of the earliest signs of kidney disease is microalbuminuria. By screening people with diabetes for microalbuminuria, physicians can treat them to delay the onset and potentially prevent kidney disease. Through screening, diagnosing, and monitoring with tests such as HbA1c and microalbumin, physicians can take full advantage of new therapeutic advances to help their patients with diabetes and reduce healthcare costs.

Trip Trepagnier
VP, Marketing and Business Development
Maker of the ACE Alera Clinical Chemistry System

Additional auto-antigen focus of immune-mediated diabetes

Type 1 diabetes (immune-mediated diabetes) accounts for approximately 10% to 15% of the total diabetic population and, while it can strike at any age, is generally seen in children and young adults. Autoantibodies to glutamic-acid decarboxylase (GADAb), protein tyrosine IA-2 (IA-2Ab), and insulin (IAA) are regarded as well-defined markers of autoimmune diabetes — and their measurement is viewed as important and useful in defining the etiology of disease. To this end, we have provided immunoassay test kits for the measurement of these key antibodies. Going forward — in collaboration with experts in the field — we are focused on the measurement of antibodies to zinc transporter 8 (ZnT8Ab), a distinct and additional auto-antigen of immune-mediated diabetes. Antibodies to ZnT8 have been identified in type 1 diabetes patients serologically negative for existing markers (GAD, IA-2 and IAA), thereby rendering its measurement useful in select indications.

Chris Viele
President/CEO
Kronus
Source for Sensitive Autoimmune Diagnostics

Precision analyzers impact HbA1c results

With the ADA recommending the use of HbA1c to screen for diabetes, test volumes in laboratories are increasing. These recent developments have led CAP to tighten its bias criteria to provide accurate HbA1c medical-decision information to physicians and patients. To meet these criteria and provide the full patient picture, it is important to use an HbA1c method that will identify abnormal hemoglobins that could impact HbA1c results. With fully automated high-performance liquid chromatography, or HPLC, solutions, laboratories can provide accurate HbA1c results and detect common hemoglobin variants.

Michael E. Jackson, PhD, Division Manager
Clinical Systems Division
Bio-Rad Laboratories
Maker of the D-10, VARIANT II and VARIANT II TURBO
Hemoglobin Testing Systems

Seamless integration of patient data

In light of current trends in healthcare reform, many hospitals are trying to find solutions to reduce costs and improve patient outcomes. For point-of-care (POC) glucose monitoring, connectivity is a particular area of focus. Connectivity between POC testing (POCT) devices and hospital information systems offers significant potential to improve workflow while enhancing patient safety. Wireless connectivity, for example, can help reduce the risk of patient identification error and, simultaneously, help improve staff efficiency by automatically transferring results to patient medical records in real time. Significant advances in POCT connectivity depend, however, on the broader adoption of communication standards by device manufacturers and hospitals. Implementing common platforms for technology and security will allow new devices to integrate seamlessly into communication infrastructures and will give hospitals and manufacturers more flexibility in achieving their ultimate goal: seamless integration of patient data to reduce errors, streamline workflow and facilitate more informed decisions on patient care.

Mary Catherine Coyle, MS, MT(ASCP)
Director, Product Marketing Hospital Point of Care
Roche Diagnostics Corp.
Maker of ACCU-CHEK blood-glucose monitoring systems

HbA1c: beyond monitoring to diagnosis of diabetes

In July 2009, an International Expert committee published a report suggesting that the HbA1c assay could be extended beyond monitoring of diagnosed diabetics to include a utility for the diagnosis of diabetes. Why is this important? The current method of diagnosis is time-consuming and inconvenient. It requires patients to fast for eight hours and have blood drawn multiple times over several hours. This can be uncomfortable and physically draining. The use of an HbA1c blood test eliminates all of this. Although no manufacturer has an FDA-approved claim for diagnosis, discussions are occurring daily within the industry and medical communities. The use of the HbA1c assay for diagnosis is a convenient, effective, and accurate method to detect diabetes. It can be accomplished with a simple finger prick or blood draw, with results available to the physician in minutes. Consultation for treatment can occur while the patient is still in the emergency room, clinic, or office. Healthcare costs can be reduced while patient and healthcare provider workflow is improved. Utilizing the HbA1c assay for diagnosis of diabetes is a win-win situation for the healthcare system but, most importantly, for the patient.

Lauren Foohey
Director of Marketing, Point of Care
Siemens Healthcare Diagnostics
Maker of the DCA Vantage diabetes analyzer

Test for diabetes management

There are 1.6 million people diagnosed with diabetes each year. We have partnered with GlycoMark to market its blood test for 1.5-anhydro-D-glucitol (1.5 AG), one of the most important tests for better management of diabetes and prevention of the devastating diseases that accompany it. This partnership will help healthcare providers manage diabetes with a complete menu of assays performed on a chemistry analyzer in their offices: HbA1c, glucose, fructosamine, insulin, kidney function tests, and, now, postprandial hyperglycemia. This is an FDA-cleared, reimbursable, non-fasting blood test that monitors intermediate glycemic control and can be performed monthly. While HbA1c identifies a person's average glucose level over time, it may miss up to 40% of patients who appear in the normal range (6.0 to 8.5) that are not in good glycemic control. This can lead to cardiovascular disease, retinopathy, and other complications of diabetes. This new blood test identifies peak glucose levels after a person eats, so physicians can identify those patients and prescribe the proper medications.

Philip G. Shugart
CEO/ President
Carolina Liquid Chemistries Corp.
Marketer of GlycoMark blood test; maker of BioLis 24i

POC instruments shifts patient screening toward HbA1c

The 2010 ADA consensus statement on HbA1c measurement and the arrival of POC instruments for the measurement of HbA1c capable of meeting National Glycohemoglobin Standardization Program (NGSP) standards mean HbA1c measurement will be the screening method of choice for diabetes mellitus in the future. The arrival of these point-of-care devices in physician offices will rapidly shift patient screening away from the practically valueless single-point glucose measurements and toward testing for HbA1c, eliminating the need for fasting prior to testing. It will also offer a more powerful evaluation of a patient's diabetic state. Accurate screening for asymptomatic type 2 diabetes patients is going to become increasingly important as this population explodes in numbers over the next 20 years. Early detection of the disease in asymptomatic individuals allows for effective intervention with lifestyle modification. This could potentially delay the need for drug therapy.

Robert W. Ban, PhD
Chairman/CEO/President
Quantimetrix Corp.
Source for Laboratory Quality Control Materials

POC blood-glucose testing with lab-like accuracy

The next big trend that the clinical lab will encounter in diabetes products and testing will be the demand for improved performance for meters and test strips used in the hospital. The FDA, the Society of Critical Care Medicine, and American Society of Clinical Endocrinology are calling for improved accuracy in this area. Typical meters and strips used in the hospital are derivatives of test strips that were developed for home testing and have been FDA-cleared for over-the-counter use. While these meters may have sufficient analytical performance for home self-monitoring by diabetes patients, hospital patients are sicker and frequently have substances in their blood that interfere with accurate glucose results. One frequent condition, abnormal hematocrits, can cause glucose errors as large as 30% on current meters and lead to insulin-dosing errors. Another interferent, maltose, has caused inaccurate glucose results that led to inappropriate treatment and several reported deaths. Recognizing the need for improved glucose accuracy, we have developed a meter and strip specifically designed for the hospital and FDA-cleared for professional use. Its technology is unique in the marketplace in that it measures and eliminates interferences such as abnormal hematocrit levels, acetaminophen, ascorbic acid, maltose, galactose, xylose, uric acid, oxygen, and other interferences.

Rick Rollins
Marketing Representative
Nova Biomedical
Maker of StatStrip Hospital Glucose Monitors and
StatStrip Multi-Well Test Strips

Discovery holds promise for treatment of diabetes
Two University of Georgia animal science researchers have 13 pigs that may hold the key to new therapies to treat human diseases, including diabetes. The discovery marks the first time pluripotent stem cells have been created from adult livestock, presenting the possibility of a method to make pigs that can be a source of cells and organs for regenerative medicine in a meaningful way, according to the researchers. The technique called induced pluripotent stem cells had previously been shown to make live offspring in mice. The discovery is a new tool for researchers who need to determine which sources of cells, adult or earlier stages such as embryonic or induced pluripotent stem cells, will work best for each disease. The new process will be valuable for a research project under way in partnership with Emory University to find better therapies for diabetes. Details of the discovery were be published in Stem Cells and Development in June. View a graphic of the process at http://tiny.cc/d7pcg or a fact sheet at http://tiny.cc/fkogl.