Rapid glucose tests help physicians monitor their diabetic patients.
Diabetes causes blood glucose (sugar) levels to rise higher than normal – a condition also referred to as hyperglycemia, according to the American Diabetes Association. Type 1 diabetes (formerly called juvenile diabetes) is caused by an immunologic injury to the insulin-producing cells of the pancreas and is often related to an infection. Type 2 diabetes – the most common form of diabetes – accounts for more than 90 percent of people with diabetes. Once referred to as adult onset diabetes, today it occurs in pre-teens as well. Type 2 diabetes is hereditary and frequently linked to obesity. In the United States, there are more than 30 million people with diabetes, and 90 million people are estimated to have a condition called pre-diabetes. Although their blood sugar level is higher than normal, it’s not yet high enough to be classified as Type 2 diabetes. Without intervention, however, pre-diabetes can develop into Type 2 diabetes.
Type 2 diabetes most frequently occurs in obese individuals who have metabolic syndrome, a condition in which a person has at least three additional medical conditions, including obesity, high blood pressure, high cholesterol and triglycerides, or elevated blood sugar. In people with Type 2 diabetes, insulin is not used properly, according to the ADA – a condition called insulin resistance. At first, their pancreas makes extra insulin to compensate. Over time, however, the body isn’t able to keep up and it no longer produces enough insulin to maintain normal blood glucose levels. Type 2 diabetes affects nearly 400 million people worldwide, about a third of whom are not diagnosed. Diabetics not receiving treatment are at greater risk for heart attacks, strokes, blindness, kidney failure and/or lower extremity amputations.
The common symptoms of diabetes include frequent urination, nocturia, constant thirsty feeling, extreme fatigue, blurry vision, slow wound healing, and tingling pain or numbness in the hands and feet. While there is no cure for the disease, proper management with lifestyle changes (healthy eating, exercise and weight loss) can prevent or reduce complications. There are several classes of oral medications that can be used to treat Type 2 diabetes, as well as injectable medications and insulin, which help regulate blood glucose levels.
People with Type 1 diabetes are unable to make any insulin and, as such, are always treated with insulin.
Diagnostic testing
The ADA focuses on three methods to diagnose diabetes:
- Oral glucose tolerance test. This is the oldest test used. Blood glucose is measured before – and two hours after – drinking a special glucose solution. A normal two-hour blood glucose reading is less than 140 mg/dL. If the value is between 140 mg/dL and 200 mg/dL, the patient is considered pre-diabetic, and a value greater than 200 mg/dL indicates diabetes.
- Fasting blood glucose. The patient fasts overnight, followed by a blood drawing to measure his or her blood glucose. A patient with a value less than 100 mg/dL is considered normal; 100 mg/dL to 126 mg/dL is considered pre-diabetic; and a value higher than 126 mg/dL is diagnosed as diabetes.
- Hemoglobin A1c (HbA1c). This test does not require fasting or drinking a glucose solution. A small amount of the patient’s blood is used to determine an indication of the patient’s average blood glucose over the last two to three months. A value of less than 5.7 percent is considered normal; values between 5.7 and 6.4 percent indicate pre-diabetes; and values of 6.5 percent or higher indicate diabetes. Hemoglobin A1c is also used for ongoing monitoring.
In the absence of apparent clinical signs of diabetes, tests should be repeated on a second day to confirm the diagnosis.
New products
Years ago, glucose and HbA1c could only be measured in a hospital’s or clinic’s clinical chemistry laboratory on large analytic machines. More recently, the availability of devices designed for use in the physician’s office, pharmacies or healthcare/wellness centers provide more immediate answers, allowing interactions between the healthcare professional and patient at the time of the visit.
Furthermore, because the successful treatment of diabetes is primarily patient (not physician) driven, it is vital that simple instruments be available to allow the diabetics to measure their glucose or HbA1c at home, enabling them to adjust and monitor their diabetes management between visits to their healthcare professional.
PTS Diagnostics recently introduced the A1CNow+ system, which provides healthcare professionals with a fast, easy, and accurate method (relative to TOSOH certified reference method) to measure Hemoglobin A1c in the exam room in five minutes. Clinicians have information to provide an immediate consultation with a patient, making it an essential tool to aid in successful diabetes management. The small, portable and battery-operated A1CNow+ is CLIA waived, CE marked, and NGSP Certified for 2014 under new, more stringent criteria. Very important to physician offices, the A1CNow+ analyzer is fully reimbursable.
The professional A1CNow+ system comes with the meter and materials (code-matched to the meter) to perform either 10 or 20 tests. After using all of the tests, the meter can be discarded. A new meter is contained in each new A1CNow+ box, so no maintenance is required. Quality control testing should be performed as part of good laboratory practice.
Target customers
- Physician offices
o Primary care, internal medicine, OB/GYN, cardiology, pediatrics, endocrinology - Dentists, podiatrists, chiropractors
- Retail & wellness clinics
- Hospitals
- Pharmacies
- Community health centers
Probing sales questions
Sales reps should ask their customers questions like the following to gauge their need for – and interest in – new products.
- “Doctor, how many patients do you see every day with diabetes?”
- “How would getting A1c results in the exam room, with the patient present, impact your practice?”
- “How long does it normally take for you to get A1c test results?”
- “How much does your office get reimbursed for A1c testing?”
Addressing customer objections
Sales reps should be prepared to address their customers’ objections or concerns regarding adding new products.
Objection: “My hospital does HbA1c tests already.”
Response: “Today, you have to send the patient to the lab. Then you must wait for the results, and finally you can contact the patient. With A1CNow+ you will have the test results in five minutes, while the patient is still in your office and can receive the benefit of your immediate counseling. This saves you and your staff time. It also saves your patient time and means your current interaction with the patient is more valuable.”
Objection: “I don’t want to hire new staff just to do be able to do a blood test.”
Response: “The A1CNow+ is a CLIA-waived, small, portable, simple device that anyone in the office can operate. In addition, PTS Diagnostics provides live and computer-based training, as well as written instructions with which your current staff can be easily and quickly trained.”
Objection: “My patients already do self-monitoring of blood glucose.”
Response: “That is terrific. You are obviously already delivering great care. But, the A1CNow+ provides different information (e.g., an indication of the average blood glucose over the last two to three months), which adds to the benefit they get from their at-that-moment self-monitoring of blood glucose measurements.”
Editor’s note: Repertoire would like to thank PTS Diagnostics for its assistance with this piece.