“Painless” glucose monitors are popular, but there is little evidence that they help most patients with diabetes

In the country’s battle with the diabetes epidemic, the weapon being aggressively promoted to patients has only a 25-cent coin and is used on the belly or arm.

A continuous glucose monitor contains a tiny sensor that is inserted just under the skin, alleviating the need for patients to prick their fingers every day to check their blood sugar. The monitor tracks glucose levels at all times, sends readings to patients’ cell phones and doctors, and alerts patients when readings are too high or too low.

Nearly 2 million people with diabetes use monitors today, double the number in 2019, according to investment firm Baird.

There is little evidence that continuous glucose monitoring (CGM) leads to better results for most people with diabetes – the estimated 25 million American patients with type 2 disease who do not inject insulin to regulate blood sugar, experts say. health. Still, manufacturers, as well as some doctors and insurers, say the devices help patients control diabetes by providing almost instant feedback to change their diet and exercise compared to daily finger prick tests. And they say it can reduce costly complications of the disease, such as heart attacks and strokes.

Continuous glucose monitors are not cost-effective for patients with type 2 diabetes who do not use insulin, said Dr. Silvio Inzucchi, director of the Yale Diabetes Center.

Of course, it is easier to put a device on your arm once every two weeks than several finger pricks, which cost less than $ 1 a day, he said. But “the price of these devices is not justified for routine use by the average person with type 2 diabetes.”

Without insurance, the annual cost of using a continuous glucose monitor ranges from almost $ 1,000 to $ 3,000.

Lower prices help drive more usage

People with type I diabetes – who do not produce insulin – need frequent data from the monitors to inject the proper dose of a synthetic version of the hormone, using a pump or syringe. Because insulin injections can cause life-threatening drops in blood sugar, the devices also alert patients when this is happening, especially useful during sleep.

People with type 2 diabetes, a different disease, produce insulin to control fluctuations after eating, but their bodies do not respond as vigorously as people without the disease. About 20% of Type 2 patients still inject insulin because their bodies do not produce enough and oral medications cannot control diabetes.

Doctors often recommend that patients with diabetes test their glucose at home to see if they are meeting their treatment goals and learn how medications, diet, exercise and stress affect blood sugar levels.

The crucial blood test that doctors use, however, to monitor diabetes in people with type 2 disease is called hemoglobin A1c, which measures average blood glucose levels over long periods of time. Neither finger prick tests nor glucose monitors analyze A1c. They cannot, as this test involves a lot of blood and must be done in a laboratory.

Continuous glucose monitors also do not measure blood glucose. Instead, they measure the level of interstitial glucose, which is the level of sugar found in the fluid between cells.

The companies seem determined to sell the monitors to people with type 2 diabetes – those who inject insulin and those who do not – because it is a market of more than 30 million people. In contrast, about 1.6 million people have type 1 diabetes.

Helping to increase demand for monitors is the drop in prices. Abbott FreeStyle Libre, one of the leading, lowest-priced brands, costs $ 70 for the device and about $ 75 a month for sensors, which must be replaced every two weeks.

Another factor was the expansion of insurance coverage.

Almost all insurance companies cover continuous glucose monitors for people with type 1 diabetes, for whom it is a proven lifesaver. Today, almost half of people with type 1 diabetes use a monitor, according to Baird.

A small but growing number of insurers are beginning to cover the device for some Type 2 patients who do not use insulin, including UnitedHealthcare and CareFirst BlueCross BlueShield, based in Maryland. These insurers claim to have seen initial success among members who use monitors in conjunction with health coaches to help keep diabetes under control.

The few studies – mostly small and paid for by device manufacturers – examining the impact of monitors on patient health show conflicting results in reducing hemoglobin A1c.

Still, Inzucchi said, the monitors helped some of their patients who don’t need insulin – and don’t like to prick their fingers – to change their diets and reduce glucose levels. The doctors said they saw no evidence that the readings lead patients to make lasting changes to their diet and exercise routines. They said that many patients who do not use insulin can benefit from diabetes education classes, going to a gym or seeing a nutritionist.

“I don’t see the extra value of CGM in this population with the current evidence that we have,” said Dr. Katrina Donahue, director of research at the Department of Family Medicine at the University of North Carolina. “I’m not sure if more technology is the right answer for most patients.”

Donahue co-authored a landmark 2017 study at JAMA Internal Medicine that showed no benefit in reducing hemoglobin A1c after a year of regularly checking glucose levels using finger prick tests for people with type 2 diabetes.

It made a big difference to my health.

She assumes that the measurements did little to change patients’ eating and exercise habits over the long term – which is probably also true for continuous glucose monitors.

“We need to be judicious when using CGM,” said Veronica Brady, a diabetes educator certified at the University of Texas Health Sciences Center and a spokeswoman for the Association of Diabetes Education and Care Specialists. The monitors make sense if used for a few weeks when people are switching medications that can affect their blood sugar levels, she said, or for people who lack the skill to do finger prick tests.

Still, some patients like Trevis Hall give credit to the monitors for helping them keep their illness under control.

Last year, Hall’s health plan, UnitedHealthcare, gave him a monitor for free as part of a program to help control his diabetes. He said it doesn’t hurt when he connects the monitor to his belly twice a month.

The data showed Hall, 53, of Fort Washington, Maryland, that his glucose was reaching dangerous levels several times a day. “It was alarming at first,” he said of the alerts the device would send to his phone.

Over the months, the readings helped him to change his diet and exercise routine to avoid these spikes and control the disease. Nowadays, that means taking a brisk walk after a meal or eating a vegetable with dinner.

“It made a big difference to my health,” said Hall.

Device manufacturers are increasingly promoting them as a way to encourage healthier eating and exercise.

Manufacturers spend millions of dollars pushing doctors to prescribe continuous glucose monitors and are advertising directly to patients on the internet and in TV ads, including a commercial starring singer Nick Jonas during this year’s Super Bowl.

Kevin Sayer, CEO of Dexcom, a leading monitor manufacturer, told analysts last year that the Type 2 non-insulin market is the future. “My team often tells me that when this market leaves, it will explode. It won’t be small and it won’t be slow, ”he said.

“I personally believe that at the right price with the right solution, patients will use it all the time,” he added.

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