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○March 5, U.S. Food and Drug Administration (FDA) First over-the-counter continuous blood glucose monitor approved, for people who have type 2 diabetes but are not taking insulin to manage their condition. The device, which first went on sale this summer, can also be used by people who don’t have diabetes but want to know how their diet and physical activity affect their blood sugar and sugar levels.
This monitor consists of a wearable sensor paired with a smartphone app to continuously measure, record, and display blood sugar levels.
“There are definitely pros and cons to making this device available without a prescription,” says Michael B. Nutter, MD, an endocrinologist and clinical assistant professor at New York University Langone. Faculty of Medicine and its members Department of Endocrinology, Diabetes, and Metabolism at New York University Grossman School of Medicine. One advantage is that the device can help people who need to track their blood sugar levels but don’t have access to a continuous blood sugar monitor through insurance. You may also discover undiagnosed diabetes or prediabetes. However, people with normal blood sugar fluctuations may worry unnecessarily about normal blood sugar changes.
“As an endocrinologist, I think there should be some guidance in interpreting the glucose data collected by these devices,” he says. “It is safest to have a health care professional analyze changes in your blood sugar levels, make a proper diagnosis, develop a treatment plan, and adjust your medications.”
Device could help monitor type 2 diabetes
If you have type 2 diabetes, which can be managed with oral medications and lifestyle changes, but don’t want to prick your finger several times a day to check your blood sugar levels, you can benefit from over-the-counter continuous glucose monitors, Dr. Nutter says. There is a possibility of receiving it.
“Not monitoring your blood sugar levels is like trying to fly a plane blindfolded,” he says. “You know you’re up in the air, but you don’t know how fast you’re going or if you’re going up or down. Continuous blood glucose monitoring effectively removes that blindfold. .”
Knowing your blood sugar levels helps you make daily decisions about medication dosage, nutrition, and physical activity. All of these help control blood sugar levels. It may also prompt you to see a doctor. Blood sugar levels that are too high can damage organs such as the eyes, kidneys, and heart over time, while blood sugar levels that are too low can cause symptoms such as dizziness, shaking, sweating, and fatigue. , very dangerous.
New commercially available continuous blood glucose monitors are not designed to monitor extremely low blood sugar levels, called severe hypoglycemia, which can be life-threatening. Additionally, this commercially available device is not indicated for people taking insulin to manage diabetes. These patients are using prescribed continuous glucose monitors, and the data from them should be reviewed by their doctors, Dr. Nutter said.
Potential price barriers
Although the device’s FDA approval was intended to expand people’s access to continuous blood glucose monitors without the involvement of a health care provider, Dr. Nutter expects there to be some price barriers.
“A potential hurdle lies in the price, which is yet to be determined and could be prohibitively high,” he said. This creates a situation where people with means can buy monitors, but people without means cannot. And for me, that’s a big ethical issue. ”
Ideally, all patients with glycemic fluctuations or actual diabetes should have access to continuous blood glucose monitoring to ensure equal access to treatment, whether prescribed or over-the-counter. , he added.
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Making the device easily available over the counter means it can be worn even by people who have no symptoms or risk factors for diabetes.
“There is an argument that this device has screening capabilities that could potentially detect very early prediabetes and undiagnosed diabetes,” Dr. Nutter said. However, efficient means to screen for diabetes already exist. It’s a simple hemoglobin A1C blood test that measures your average blood sugar level over a 3-month period.
Even people without diabetes can misinterpret blood sugar levels. Continuous glucose monitors don’t directly measure blood glucose levels, Dr. Nutter said. They measure the flow of glucose in the interstitial fluid in the spaces between cells. Glucose data from a finger prick or blood draw is different from data collected from continuous monitoring, so people may not be aware of these differences.
Dr. Nutter is concerned that some of the normal blood sugar spikes that continuous blood glucose monitors may record after meals may be misinterpreted. “Many people who don’t have any diabetes may experience what’s called a postprandial, or normal postprandial, blood sugar spike,” he says. People may be tempted to avoid or demonize healthy foods that spike blood sugar levels, even if these fluctuations are within normal limits.
The postprandial rise in blood sugar levels detected by the sensor could be misinterpreted as a warning sign, causing undue psychological harm and prompting people to seek unnecessary medical attention, Dr. Nutter said. “Too much data can certainly have downsides.”
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