In New York City, 530,000 people have been diagnosed with diabetes, and another 265,000 have it but don't yet know.
"Diabetes is an urgent public health crisis in New York City," said Diana Berger, medical director of the Diabetes Prevention and Control Program (DPCP) in the New York City Department of Health and Mental Hygiene. "The prevalence of diabetes has doubled from 1994 to 2004 from about 4 percent to 9 percent, with areas such as the south Bronx where the prevalence is up to 18 percent."
To combat this growing epidemic, the DPCP wants to collect in a central database patient information relevant to the disease -- such as results from the hemoglobin A1c blood test, which tells physicians what a patient's average blood sugar has been over the past three to four months.
The Board of Health will vote in December on whether to pass the proposal to start this pilot in the Bronx.
"As our commissioner [Thomas Frieden] says, he does not use the word 'epidemic' lightly," Berger said. "He's trained in infectious disease and tuberculosis control, where they certainly are epidemics. And diabetes does fit into the category of epidemic in the city, in the country, in the world."
Those with diabetes who don't keep their hemoglobin A1c levels at a normal to excellent range are at a higher risk for heart disease, stroke, kidney failure and amputations, among other difficulties. A normal hemoglobin A1c is less than 6.5 milligrams per deciliter (mg/dl), an excellent A1c is 6.5-7.5 mg/dl, good is 7.5-8.5 mg/dl, fair is 8.5 to 9.5 mg/dl, and any greater than 9.5 mg/dl is poor.
There are other strains and complications as well.
"The estimates of the American Diabetes Association are that about $132 billion a year is spent in the direct and indirect care for people with diabetes. It's a tremendous financial burden," Berger said. "In New York City, we know that among people with diabetes, there's a twofold increase in significant psychological distress, including anxiety and depression. So there's tremendous economic, psychosocial and medical complications associated with diabetes. It's devastating."
The Department of Health intends to use the collected data to create an effective intervention program, potentially reducing morbidity and mortality from diabetes.
"We're still grappling with what the best intervention will be, but it will probably be some type of feedback to clinicians and patients," Berger said, adding that one model the department is looking at is the Vermont Diabetes Information System, a research trial funded by the National Institutes of Health's National Institute of Diabetes and Digestive and Kidney Diseases. "They're feeding back rosters of patients to primary care clinicians," Berger said.
Most doctors see patients one by one, and don't think of them in terms of a large population. By keeping track of diabetic patients' A1c results, the Department of Health can send information to individual doctors about their diabetic patients and where each falls in the A1c categories.
"It will help clinicians hone in on the patients who need the most support, who may need intensified therapy," Berger said. "Since there is a limited amount of time and resources that clinicians have with their patients, maybe those whose A1c is under 6 they may not need to see as frequently."
Patient feedback may also help, as only 10 percent of people with diabetes know what their A1c is, Berger said.
"That can be for many reasons. Either doctors aren't sharing that information with their patients, or they're sharing it and their patients aren't understanding it, they're sharing it and the patients forget," she said. "If you don't know your A1c, you don't have a goal, and in medicine, we often say, 'If you're going to do a test, you have to do something with it.'"
For those with diabetes, testing the blood sugar at home daily will also aid in control.
ECLRS on Alert
Physicians, health-care facilities and licensed clinical laboratories are already required by law to report all pertinent facts to public health authorities whenever a New York resident is examined to determine blood lead level, or when results are positive for a reportable communicable disease or cancer.
The New York State Department of Health collects this information at the state level using the Electronic Clinical Laboratory Reporting System (ECLRS) -- a single electronic Web-based system for secure and rapid transmission of the above information.
In the collection of hemoglobin A1c results, the testing laboratory accesses the ECLRS through New York's Health Provider Network (HPN), a password-protected Web site, and manually enters test results or uploads a special data file.
The HPN is a secure network that meets the Health Insurance Portability and Accountability Act of 1996 and New York state health data security policy requirements.
"We have the infrastructure to collect large quantities of data for all of the communicable lab values, and lead," Berger said. "So we'll be asking labs to tack on one extra lab value. If the recommendation is that people get an A1c two to four times a year, we anticipate getting millions of A1cs in."
This large amount of data will be useful from a surveillance perspective, Berger said, so the DPCP and the New York City Department of Health can get a sense of pocket areas in New York City where patients' blood sugar control is better or worse, and how they can focus more resources on those areas.
"The reason the commissioner is approaching this so seriously is [that] this type of collection of A1c has never been done anywhere -- in the country or the world -- on a population level," Berger said. "Traditionally the New York City Department of Health, and all departments of health, have focused on diseases that killed people 100 years ago, so for him to start thinking about prevention and control of chronic disease is very forward-thinking."
Targeting Type 2
Of New York City residents diagnosed with diabetes, approximately 95 percent have type 2 diabetes. With type 2, according to the American Diabetes Association, either the body does not produce enough insulin or the body's cells ignore it.
Because the majority of those with diabetes have type 2, that's where the Department of Health is focusing its efforts.
"With type 2, you have diabetes an average of five to seven years before you're diagnosed, and type 1 is usually very rapid," Berger said. "In the very early stages [of type 2], the symptoms are milder and vague, nonspecific -- some fatigue or being more prone to infection. It's not the severe weight loss you get with type 1 or the severe thirst. It's kind of slow and insidious with type 2, and that's why people can go for so long and not even present to the doctor that they're not feeling well."
And the longer one goes without being diagnosed, the more the disease takes a toll on the body, and the more likely complications -- such as heart disease, stroke, kidney failure and amputations -- will arise in the future.
Concerns about patient privacy cover the spectrum, Berger said, adding that the Department of Health has a 150-year history of handling and collecting very sensitive and confidential medical information without any breaches.
"Any information collected will only be released to the ordering clinician and the patient, so any fears around it being released to health insurance, or life insurance, or department of motor vehicles -- we've put very careful confidentiality language into the proposal," she said, adding that the Department of Health takes patient privacy very seriously.
"My personal opinion is that the public health benefits, in terms of surveillance and potential interventions, outweigh any risks, and really we can very comfortably, confidently address any of the privacy concerns," Berger said, adding that there will be ways to opt out of the program.
Sandra Pianin has had type 2 diabetes for three years, and said her blood sugar numbers rise and fall along with her stress levels, which can be a struggle.
Pianin believes the diabetes registry is an excellent idea -- as long as it's used for the right reasons.
"I have looked all over New York City trying to find a clinic that serves diabetics," she said. "While there appear to be one or two in the New York City hospital system, they do not accept my medical insurance and are located in places difficult to get to. The registry might alert health officials to the great need for diabetics to get better medical care, especially when there are other diseases involved -- especially psoriasis, depression and other mental health issues like post-traumatic stress disorder.
"I'm not worried about privacy -- I am worried about not getting appropriate services or getting outdated information from doctors."