Sensing an epidemic of type 2 diabetes among its residents, New York City has made a bold and controversial move to monitor residents’ lab tests and intervene in some way when individuals’ hemoglobin A1C blood test results are over a well-established target. Since January 23, 2006, nearly every laboratory in the city (all 127 connected to the state’s Electronic Clinical Laboratory Reporting System) must, by law, electronically report all A1C test results to the city’s health department, even before patients give their consent.

Privacy issues have prompted some advocacy groups to object to the new reporting requirement, called the "A1C (or blood sugar test) registry." Independent medical testing laboratories have cited not only legal but financial, workload, and data collection concerns. NYC's health department views the problem differently, saying constitutionally-required confidentiality is being maintained while the health and economic burdens of thousands of individuals and the public are being improved. No government in this country—city, state or U.S.—has ever mandated that this personalized type of surveillance be used to thwart a disease that is not infectious. (Veteran’s Affairs hospitals have broken ground to some extent with electronic diabetes surveillance and management programs and so have some managed care organizations and commercial health plans. Electronic programs in New Zealand and Australia have also been implemented in hopes of helping patients and healthcare providers better control diabetes.)

A July 25, 2005 Associated Press news story reported that the American Diabetes Association considered New York’s proposed plan a tool that could help clinicians track patients over long periods, particularly patients who change healthcare providers and those too poor to have their own doctor. The 7% A1C target may not be ideal for everyone, however, which is a reason some people say government should not interfere with topics best managed individually and within the patient-provider relationship. A new study published in the January 2006 issue of the American Heart Journal, for example, and featured on the Web site of the American Diabetes Association, showed that in diabetics with advanced heart failure, high A1Cs were associated with improved survival.

New York City is home to more than a half million cases of diabetes and an estimated quarter of a million more cases that are considered to be undiagnosed. Nine percent of NYC’s adult residents are estimated to have been diagnosed with type 2 diabetes, including 20% of adults over age 65. Department of Health officials have offered compelling statistics to explain the toll diabetes is taking on the city and the aggressiveness and wisdom of their intervention. In 2003, they say, more than 1800 deaths in the city were due to diabetes, more than 1700 residents had amputations because of diabetes, and nearly 20,000 people were hospitalized for reasons related to diabetes. Diabetes treatment alone costs the city $5 billion per year, an estimate that does not include costs for diabetes-related heart disease, stroke, blindness, and kidney failure.

City officials cite a 150-year history of collecting and guarding personal health information without privacy breaches (for tuberculosis, HIV, and hepatitis, for example) and say diabetes has become a major public health threat. They say the A1C test results will be given only to the patient and the healthcare provider who ordered the test as feedback and support; insurers, employers, or others who might discriminate against patients have no access to the information. The American Clinical Laboratory Association (ACLA) has told the city it is concerned about invasion of privacy and the legality of reporting such information, given that diabetes is not an infectious disease and, as such, does not pose a serious health risk to others. The ACLA and others are also concerned because the city is collecting the information first and asking for individual patient’s permission only after it obtains their first bad results and notifies their healthcare provider.

Laboratories have been given responsibility for obtaining and providing to the city the name and address of each person whose test result does not meet the goal. In a pilot program in the South Bronx, where 48,000 diabetics live and about 270 clinicians work with diabetes patients, the city has talked about giving healthcare providers a roster of their patients broken down by the level of glycemic control and a summary of best practice recommendations, plus a daily alert of any A1C test results greater than 8% among their patients. The hope is that doctors will pay closer attention to patients whose results are of concern. Following up on the alerts to healthcare providers, the city hopes to send letters to individuals whose blood sugar level exceeds the recommendation and places them at increased risk for devastating complications. At this point, patients can ask to be removed from the registry. The letter would be accompanied by educational and resource materials to help the person with diabetes understand the importance of the A1C level and what lowers it.

The board of health’s notice on adoption of the A1C registry notes that an A1C below 7% reduces complications related to the small blood vessels (including eye disease, kidney disease, and peripheral nerve disorders) by 25% and that controlling A1C, blood pressure, cholesterol and smoking may lower cardiovascular events by 50%. A person with diabetes can suffer amputations, hospitalizations, heart disease, stroke, blindness, kidney failure, nerve damage, and other devastating health problems.

Blood sugar control is important in avoiding many of these problems but difficult for many people to manage. The city’s public health officials hope to reduce diabetes death rates and the life-threatening complications associated with diabetes by communicating directly with patients and their healthcare providers. The city may soon learn whether patients welcome this help or resent the intrusion. The health department also hopes to identify neighborhood clusters in which many residents’ blood sugar levels are being poorly controlled so the city can direct public health resources to those communities. Another goal is to spot trends in the growing number of cases of type 2 diabetes in children.

Sources
S1
New York City Department of Health and Mental Hygiene Board of Health. Notice of adoption to amend Article 13 of the New York City Health Code. On the Internet: http://www.nyc.gov/html/doh/html/notice/notice.shtml. Accessed 23 Jan 2006.

S2
Caruso DB. New York City health staff may start to track diabetics. Seattle Times (from The Associated press). On the Internet: http://seattletimes.nwsource.com/html/health/2002402162_diabetes26.html. Accessed 23 Jan 2006.

S3
Reuters Health. Poor Diabetes Control May Be Better for Some. 17 Jan 2006. On the Internet at the Web site of the American Diabetes Association: www.diabetes.org/indiabetestoday.jsp?WTLPromo=HOME_diabetestoday. Accessed 23 Jan 2006.

S4
Silver LD and Berger DK. Improving diabetes care for all New Yorkers. On the Internet: http://www.nyc.gov/html/doh/html/downloads/pdf/diabetes-presentation-a1c-registry.pdf. Accessed 23 Jan 2006. Alternate Web access through the NY Academy of Medicine: http://nyamlibrary.blogspot.com/2005_12_01_nyamlibrary_archive.html.

S5
American Clinical Laboratory Association. Re: Notice of intention to amend Article 13, Sections 13.03(a)(1) and 13.04 of the New York City Health Code (letter). On the Internet: http://www.clinical-labs.org/documents/A1cComment.pdf. Accessed 23 Jan 2006.