Dr. Howard Wolpert Helps Set Guidelines for CGM Use
Thursday, December 15, 2011
After two-and-a-half years of conference calls, meetings, and extensive literature review, a panel of doctors, including Howard Wolpert, M.D., Director of the Insulin Pump and Continuous Glucose Monitoring Programs at Joslin, have compiled the findings of a number of studies on real-time continuous glucose monitors (RT-CGM) into a series of guidelines recommending the proper use of the devices.
“With RT-CGM, there’s that minute-by-minute decision making that gets enhanced,” said Dr. Wolpert. “Being able to review the data, see what the patterns are, and make changes in ones’ treatment approach helps as well.”
Real-time continuous glucose monitors have been on the diabetes care scene since their FDA approval five years ago. They have proved to be a useful technology for improving diabetes management, and after years on the market, “it was time for a more authoritative position statement about what the role of the technology was in clinical care,” Dr. Wolpert said.
Continuous glucose monitors have existed since the late 1990s. Back then, blood glucose levels were recorded and stored over the course of a few days. Patients then needed to download the information to a computer to study the trends in their changing glucose levels, but they didn’t get live notifications of the status of their glucose levels as it was happening.
Real-time CGM devices add an extra level of awareness to diabetes care. Patients are notified when their blood glucose drops too low or spikes too high. They can respond immediately, reducing the risk of hyper- or hypoglycemia. The devices also offer the same download-and-review capability available in their predecessors.
The team that created the official guidelines reviewed the results from many studies involving RT-CGM and came up with the following recommendations, which were published by the Endocrine Society in their Journal of Clinical Endocrinology & Metabolism.
- They recommend that currently approved RT-CGM devices be considered for use by children (over 8-years old), adolescents, and adults with type 1 diabetes whose A1C levels are below 7 percent to help maintain target levels while reducing the risk of hypoglycemia.
- They also recommend the use of these devices to assist with intensification of diabetes control in children (over 8-years old), adolescents, and adults with Type 1 Diabetes whose A1C levels are at 7 percent or higher, provided they have a history of responsible self-care, and will keep up proper use of the device
- They suggest that the occasional use of short-term CGM monitors could be helpful in keeping track of blood glucose levels when reviewing conditions such as nocturnal hypoglycemia, dawn phenomenon, and post-prandial hyperglycemia; hypoglycemic unawareness; and in patients who have recently made major changes in their care, such as the use of new insulin or the switch to insulin pumps. This suggestion was made for children (over 8-years old), adolescents, and adults.
- They recommend against the use of RT-CGM on its own during treatment in an intensive care unit or in an operating room until more studies are done to asses the technology’s accuracy and safety under those conditions.
Patient expectations are crucial to the success of using RT-CGM. The guidelines recommend that patients be well educated about the hurdles that come with being constantly linked to the device. Studies have shown that the “people who had realistic expectations around what the technology promised tended to do better,” said Dr. Wolpert. When the patients expected problems, they were less likely to get frustrated and quit when those problems inevitably cropped up.
“It’s a new technology, the devices are still relatively rudimentary,” said Dr. Wolpert. “They require a certain amount of engagement in terms of troubleshooting to keep them functioning accurately.”
It’s a trade-off, he said. There may be some occasional annoyance, such as the alarms that sound when glucose shifts too far out of a specified range. But for many, the benefits of knowing even more precisely what is happening in their body will far outweigh the hassles.
To decrease these hassles, Joslin provides plenty of education on how to properly use the devices. The Joslin Clinic hosts classes on how to troubleshoot, interpret the data, and make the right nutrition choices based on readings from the RT-CGM devices.
But the important thing to remember about RT-CGM is that “the technology is not a panacea in and of itself,” Dr. Wolpert said. “It doesn’t automate diabetes management. The individual still needs to be knowledgeable and engaged. But it provides people with more information, so they can make better decisions.”
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