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WellDoc pilot shows clinical improvements in diabetics

A cell phone–based DM software program was found to improve diabetic patients’ A1c levels within three months, according to a study that will appear in the June Diabetes Technology & Therapeutics.

A nonblinded, randomized, controlled trial of WellDoc’s Diabetes Manager software, which combines medicine with coaching, found an average two-point drop in patient hemoglobin A1c within 90 days.

WellDoc, located in Baltimore, was cofounded by a group of endocrinologists trying to improve diabetes patient care beyond the doctor’s office. Suzanne Sysko Clough, MD, a cofounder of WellDoc, coauthor of the study, and a former endocrinologist in the Joslin Diabetes Center at the University of Maryland Medical Center, says her colleagues noticed that regardless of the patient’s economic status, there was one common denominator: the cell phone.

Following three years of research and discussions with physicians and patients, WellDoc has created a program that uses the everyday piece of technology to help diabetics stay engaged and improve their habits and clinical results. The Diabetes Manager software provides real-time feedback on patients’ blood glucose levels, displays patients’ medication regimens, and incorporates hypo- and hyperglycemia treatment algorithms.

Clough says to properly care for a person with diabetes, the whole team of stakeholders must be involved, including the DM companies, health insurance companies, physicians, patients, and caregivers.

“We said we somehow have to connect all of these stakeholders,” says Clough.

The three-month pilot tested whether the program could help reduce A1c levels, whether physicians would use it and empower patients to make decisions, and whether the patients would use and learn from it.

“These results demonstrate that a multifaceted intervention of education, patient feedback, and real-time individualized data between patients and providers eliminated barriers to controlling blood glucose,” according to the study.

At the start of the pilot, researchers found that none of the patients knew their blood sugar goals or how to count carbohydrates. In fact, Clough says the longer the patient had diabetes, the less they knew about the disease. She suggests this is because providers did not have the information that is now available when the patients were diagnosed, and health officials probably assumed that those living with the disease for a long time were educated about diabetes and didn’t need further teaching.

In the 90-day pilot, researchers recruited 30 patients with type 2 diabetes from three community physician practices in the Baltimore area and separated them into two groups.

Those in the intervention group received WellDoc services, including:

Use of cell phones with WellDoc’s Diabetes Manager software.

Diabetes logbooks with suggested treatment plans sent to patients’ physicians at least every four weeks.

Bluetooth-enabled blood glucose meters, blood glucose testing strips, and lancets.

Education on the proper foods to eat. “We realize that information that we gave people on lifestyle management had to be relevant and personalized based on a lot of factors,” Clough says.

Nutrition education, such as counting carbohydrates and stressing the importance of exercise.

Those in the control group were given blood glucose meters, testing strips, and lancets and were asked to send their blood glucose logbooks to their physicians every two weeks until their blood glucose levels were stabilized within the target ranges. They did not receive the cell phone–based software.

Clough says only two patients in the control group consistently sent in their logbooks, which mirrors national norms. “Part of the problem is we know the primary care physicians are not getting the data from patients to make decisions,” she adds.

At the time of registration, WellDoc input information from intervention patients, including demographics, length of diabetes, severity of the illness, medication, A1c figures, and target blood glucose. Clough says WellDoc found at least one medication error for every intervention patient.

With the prepopulated information and ongoing test results, WellDoc coached the patients on taking care of their disease.

Clough says those in the pilot’s intervention group could be placed into three groupings: those who made dietary changes, those who refused to make dietary changes but were given more medicine, and those who made dietary changes and needed medication changes. The pilot saw improvements in all three groups.

At the end of three months, Clough says those in the intervention group either believed WellDoc taught them enough to move forward without the cell phone program or said they still needed it.

“The majority of people said, ‘Please, don’t take it away from me because I need big brother watching. It is holding me accountable,’ ” says Clough.

One issue WellDoc faced during the pilot program was the unreliability of the Bluetooth technology. Two or three patients’ Bluetooth worked consistently, but others needed to manually input their data into the cell phone. Those without the Bluetooth technology pressed a button on the cell phone and used screenwide data, boxes, and labels. There was no text messaging involved.

Clough says there were initial concerns as to whether senior patients would use the cell phones, but WellDoc found that seniors operated the cell phone solely as a diabetes coach and not as a phone.

Program with physicians in mind

One problem for PCPs and endocrinologists is lack of time. Physicians simply don’t have the time to properly care for diabetes patients in a 15-minute session, Clough says.

“It’s a very difficult situation for a doctor to sit down, have the time, and take a longitudinal look at a person’s diabetes,” she says.

Mark Saba, MD, a physician in Cockeysville, MD, who volunteered for the pilot program and a longer ongoing study, says WellDoc’s services educate his patients while not adding work on his end. WellDoc is an example of how outcomes improve when patients have more information about their disease, he says, adding that he wants patients involved in their care, and the WellDoc product helps him, as a doctor, stay informed about the most recent clinical guidelines and medications.

Saba has seen A1c numbers drop in patients who are engaged. “It’s very rare to have a diabetic that is under great control who is not engaged,” he says.

WellDoc provides another education source for the patient and helps keep patients on track between doctor appointments, Saba says. Patients are able to link how they feel with their meals and exercise by following their progress on the cell phone.

“It’sa positive reinforcing cycle: The better the patient’s blood glucose readings,the more engaged they become,” Saba says. “All of a sudden, it’s not just me saying do this and you will feel better, they actually do feelbetter and become independently motivated to monitor their diabetes in apatient-orientedmodule with information they can relate to and also know their physician is monitoring as well.”

Five pilot programs in 2008

Clough says WellDoc plans to launch five U.S. pilot programs this year. WellDoc is involved in a larger 300-patient trial that it is conducting with CareFirst health plans—which cover people in Maryland, Delaware, and Washington, DC—and the Maryland University School of Medicine. The yearlong study, which currently includes about 30 physicians and 100 patients, features technological advances since the pilot, including an option that gives physicians the most recent evidence-based guidelines on a Web site. This is different from the pilot, which forwarded an action plan to physicians but didn’t have a site devoted to the most recent guidelines.

With the three-month pilot information in hand, Clough says WellDoc has shown that technology can bridge the gap between diabetes cases and shortages of doctors and time. She adds that healthcare needs to look “outside the box,” and WellDoc’s technology is an example of that thinking.

“We need physicians, we need nurses, we need nurse practitioners in the clinics, but we also need to support the patients outside of there,” says Clough.

One barrier to greater technology and physician support is the lack of reimbursement to oversee a program such as WellDoc. Clough says technology programs save time for physicians and improve outcomes for patients, and health plans should reimburse doctors for their care support services. “If physicians are [using technology such as WellDoc], and that’s driving outcomes, they should be paid for that,” she says.

Clough says WellDoc is working with telecom companies to further improve the system’s features—for example, using GPS technology so that the system could give diabetes patients the names of nearby restaurants with diabetes-friendly offerings. WellDoc is also exploring a program in which people could input what they ate and the program would automatically record the nutritional information.

Barriers to controlling blood glucose

Suzanne Sysko Clough, MD, cofounder of WellDoc, located in Baltimore, says there are five barriers to controlling blood glucose:

Lack of nutritional education for patients and physicians. “Most medical schools do not train their physicians in anything having to do with nutrition and diet,” says Clough, but education is the “cornerstone of diabetes” care.

Diabetes is complicated. Regular life circumstances, such as stress and anxiety, affect blood sugar.

There is a lot of shame with diabetes because people associate the disease with self-indulgence. Those with the disease blame themselves and think that if they need to take another pill or more insulin, they have failed.

Diabetes is a burdensome disease. People have to regularly test their blood sugar, which is difficult in a hectic life.

Americans are simply not exercising enough. “Lifestyle management is by far the most important part of the disease, especially early on,” Clough says.