Seeing the Whole Picture

• By David Kopf
• Dec 01, 2008

New study: continuous glucose monitors help diabetes patients better monitor their condition and improve outcomes.


For diabetes patients, knowing their blood glucose is serious business. If they don’t achieve the right levels, they risk complications such as blindness, kidney disease, heart attack and stroke.

Startlingly, fewer than half of all diabetes patients achieve their target levels, according to the Juvenile Diabetes Research Foundation (New York; jdrf.org). Even more surprising is that there are now devices available to them that can monitor their blood sugar throughout the day.

Non-stop Monitoring
Continuous glucose monitors (CGMs) are small devices that require the user to wear a patch-like sensor that contains a tiny wire that is inserted under the skin to measure glucose levels, according to Aaron Kowalski, program director for metabolic control at JDRF. The devices are worn between three and seven days a week, depending on the patient.

“You get readings, depending on the sensor, either every five minutes or every minute,” Kowalski explains. “If you think about what a person with diabetes has typically been doing, they have been sticking their finger, drawing blood and getting a number. You can imagine how that is a burden; sticking your finger is painful and inconvenient.”

Depending on how intensively the patient is monitored, that could mean two, four, or possibly eight readings, he says. But a CGM can deliver 288 or 1,440 readings a day. That volume of data means patients and their caregivers are no longer just seeing static readings — they are seeing context.

“A reading of 90 might be a good number, but it is close to hypoglycemia, which is very dangerous for people with diabetes,” Kowalski says. “What if it is dropping rapidly? The continuous monitors give you real-time information with trends. So you know if it is 90 and flat, 90 and going down, or 90 and going up.”

The bottom line value for CGM’s, Kowalski says is that, “You put this on and you get better diabetes outcomes.” Data from a 10-site, six-month clinical trial conducted by the JDRF bears out that conclusion. The JDRF study showed that using CGMs helped patients better manage their blood sugar levels, and suggested that more frequent use of CGMs also helped patients better manage their blood glucose levels.

Funding for CGMs
So why aren’t patients banging down your doors demanding CGMs? Simply put, they are new — CGMs only gained FDA approval in 2005 — and it can take between two and five years for insurance providers to warm up to new technologies.

“Continuous glucose monitors are a new technology and new technologies often take two to five years to be reimbursed by health insurance,” says Cynthia Rice, director of new technology access for JDRF. “We’re trying to accelerate that, given the importance of this new technology.”

The importance of those positive outcomes lies not just in the increased patient compliance, but in decreased cost to the health plans. Complications related to missed blood sugar levels cost the United States $174 billion dollars a year in medical and related costs, according to the JDRF.
So the JDRF has been taking its findings to various health plans to brief them on the results of its study to convince them that covering CGMs make sense.

“We designed our clinical trials with input from health plans,” Rice explains. “Now we’re going back to them to say ‘here are the results and this is why you need to cover these devices for people with type 1 diabetes.’”

Before the results of its study came out, Rice says that some regional Blue Cross and Blue Shield plans were providing coverage and some national plans are providing limited coverage focused on patients that experience recurrent low blood sugar. Now the effort is on to encourage those plans to expand their coverage and get more plans on board. Fortunately, patients are helping, Kowalski says.
“This was one of the most highly anticipated tools for a person with diabetes when it came to market, and now that it is available, there is a huge demand,” he says.

Increased demand from patients appealing for coverage, along with the new study, are helping advance coverage uptake more quickly, Rice adds. However, Medicare might be a little later to the game, than private payors, she adds.
“This is like what happened with insulin pumps: The private plans actually covered them before Medicare did,” she explains, adding that while patients aged up to 72-years-old were studied in its trial, it wasn’t focused specifically on older patients. “There hasn’t been a lot of studies yet with patients over 65, and Medicare wants to see data in patients over 65 before they consider coverage.”

This article originally appeared in the December 2008 issue of HME Business.