While there are other iCGM (integrated continuous glucose monitor) systems currently on the market, including an older version of the same product made by Abbott, the continuous glucose monitoring sensor in the FreeStyle Libre 2 has the longest wearing time, at 14 days, notes the Abbott Park, Illinois–based company. The new platform also allows patients to see real-time blood sugar readings, and set optional alarms that will sound in real-time when glucose levels get too low or too high. “The iCGM designation and the addition of alerts are significant improvements for patients with insulin-reated diabetes,” says Marc Breton, PhD, an associate professor of psychiatry and neurobehavioral sciences at the University of Virginia School of Medicine in Charlottesville, who researches blood glucose and insulin dynamics. For the most part, though, the new product is an “incremental improvement over the previous version of the same sensor, the FreeStyle Libre,” Dr. Breton says. Pricing for the FreeStyle Libre 2 will be the same as the previous version of this product, according to Abbott. RELATED: FDA Approves First Implantable CGM for People With Diabetes
What’s Continuous Glucose Monitoring?
Before the development of continuous glucose monitors, people with diabetes often had to do a finger stick test several times a day to measure their blood sugar levels. People with type 1 diabetes do multiple tests, including before and after meals, while people with type 2 diabetes might test themselves daily — or more or less frequently — depending on the severity of their disease and whether they use insulin. One drawback of finger stick tests, though, is that they only provide a snapshot of blood sugar levels at a single point in time. People who experience dangerously high or low blood sugar at other points during the day, or at night while they’re asleep, might not realize this is happening with periodic finger stick tests. With continuous glucose monitors, patients get readings throughout the day and night, helping to manage blood sugar more effectively and prevent dangerous spikes and dips. Continuous glucose monitoring can also help identify patterns in how insulin and other medications, as well as diet and activity, can impact blood sugar and allow people to adjust accordingly to better manage diabetes. Earlier continuous glucose monitors needed to be implanted under the skin of the abdomen to detect blood sugar levels, then wirelessly transmit readings to a device patients would wear or carry to record this data. While patients or doctors could download data to look for trends and adjust treatment plans, this required a computer. RELATED: Marathoner With Type 1 Diabetes Shares How She Uses Her CGM
Advantages of the FreeStyle Libre 2
Newer models are worn outside the body and integrate data recording so it’s no longer necessary to download data for analysis. With the FreeStyle Libre 2, patients can scan the sensor with a handheld reader to see their current glucose levels and trends over the previous eight hours. This system also uses Bluetooth technology to alert users when blood sugar gets too high or too low without needing to scan the sensor. Patients who get readings that don’t match their symptoms or expectations may still need to use a finger stick blood test to help inform treatment decisions, according to Abbott. Newer-generation products that win FDA approval to be marketed this way need to do a lot more than just communicate with a hand held scanner or with devices that can pump insulin into the body, Breton says. “It also ensures minimum levels of accuracy, the capacity to stream data in real-time to other applications, and a regulatory framework of a class 2 medical device with special control that should allow much faster iterations of the product in the future,” Breton says. So-called class 2 medical devices don’t require the most stringent FDA regulation or approval processes, and can include products like blood pressure cuffs, condoms, pregnancy tests, and power wheelchairs. RELATED: When CGM Service Fails: 5 Tips for Creating a Backup Plan
How Automated Insulin Delivery Works
One advantage of an iCGM system like the FreeStyle Libre 2 is that it can be paired with an automated insulin pump, says Roman Hovorka, PhD, of the University of Cambridge Metabolic Research Laboratories in England. Linking a continuous glucose sensor to an insulin pump can double the benefit by reducing blood sugar, increasing the time that patients have glucose levels in a safe and healthy range, and by reducing the risk of dangerously low blood sugar, or hypoglycemia, Dr. Hovorka says. “Glucose sensing without taking action has little benefit,” says Hovorka. “Automated insulin delivery allows the cycle measurement-action-measurement to be taken automatically all the time.” RELATED: FDA Green-Lights Marketing of Hybrid Closed-Loop System for People With Type 1 Diabetes
Insurance Coverage for Continuous Glucose Monitoring
What you pay for continuous glucose monitoring depends on whether your insurance covers it for your specific medical circumstances, including whether you have type 1 or type 2 diabetes and how often you use insulin. Medicare covers continuous glucose monitoring for certain people with diabetes who use insulin multiple times daily to make diabetes treatment decisions. Medicaid coverage varies by state. If you have private insurance, or coverage through your employer, benefits for continuous glucose monitoring will depend on your exact policy and may also depend on certain criteria like what type of diabetes you have and how often you use insulin. Call the number on the back of your insurance card and ask your specific provider about coverage for this device and similar options.
