FDA Warns Against Non-Invasive Blood Sugar Measurement Devices: What Does This Mean for Healthcare Tech Innovations?

Chosun Ilbo DB

While healthcare services that measure blood sugar levels with smartwatches and smart rings are being developed one after the other, the US Food and Drug Administration (FDA) has suddenly put the brakes on them. The FDA states that the ‘non-invasive’ method of measuring blood sugar without piercing the skin is less accurate and can lead to risks that directly affect the patient’s life.

In order to enter the global market, including the United States, where there are approximately 37 million people with diabetes, the company must overcome FDA regulatory hurdles. Ultimately, it is expected that the key will be for companies to prove the accuracy of their blood sugar measurement services.

The FDA warned on the 21st (local time) that non-invasive blood sugar measurement functions such as smart rings and smart watches should be avoided. The FDA “has not approved smartwatches or smart rings designed to measure blood sugar levels on their own,” he said, adding that the warning applies to any watch or ring, regardless of r brand, which claims to measure blood sugar levels in a non. invasive means.

The FDA believes that smart devices measure blood sugar levels incorrectly, which can lead to diabetes management errors.

For patients with type 1 diabetes, the food they eat and their daily exercise affect their blood sugar levels, so they need to measure their blood sugar levels frequently and inject insulin. Therefore, blood sugar levels are checked regularly by collecting blood or using a sensor that continuously monitors blood sugar levels by piercing the skin with a needle.

Dr. Robert Gavey of the American Diabetes Association also said, “Using unapproved smartwatches and smart ring devices can lead to inaccurate blood glucose measurements and potentially devastating results.” Inaccurate measurements can cause patients to take the wrong amount of medication, causing dangerous blood sugar levels, mental confusion, coma, and even death. If you take too much insulin, the level of glucose in your body can drop significantly and you may lose consciousness.

Since the FDA has sounded the alarm, attention is being paid to see if IT companies’ blood sugar measurement technology will be able to overcome the FDA’s threshold in the future.

Currently, major IT companies are competing to develop technology that can measure blood sugar levels through smart devices such as rings or watches without piercing the skin, like a fingertip, with a needle. Apple plans to use a silicon photonics chip to measure glucose levels in the body by shining laser light under the skin. Samsung Electronics is also said to be considering the possibility of developing technology related to blood sugar checking based on bioactive sensors.

Blood sugar measured using Daewoong Pharmaceutical’s ‘Freestyle Libre’ Continuous Glucose Monitoring (CGM). /Daewoong Pharmaceutical

Diabetic patients have complained that the current invasive blood sugar measurement method, which requires direct blood collection with a needle, is inconvenient and difficult. You have to carry a blood sugar meter, and you have to draw blood and measure it in front of others. The companies believe that these inconveniences can be solved with IT technology.

Currently, the only wearable devices approved by the FDA are continuous blood glucose monitoring (CGM) devices from Medtronic and Dexcom, which differ slightly from the technology and blood sugar measurement method being developed by Apple and others.

Since the late 1990s, a new blood glucose meter called the ‘Continuous Blood Glucose Monitoring System (CGMS)’ has been developed, and the first product to get FDA approval was Medtronic’s ‘CGM GOLD’, which was approved and released the late 1990s. for professional use. This is a method that allows electrodes to be inserted and attached to the patient’s skin for three days and then data can be seen three days later. Dexcom and Abbott have released similar products one after the other.

The disadvantage of the early CGM was that patients could not see their blood sugar levels in real time, making it difficult to react immediately when hypoglycemia or hyperglycemia occurred. Since then, as technology has developed, products that can measure blood sugar in real time have emerged.

The latest continuous blood sugar monitoring device approved by the FDA is a patch device that is attached to the skin such as the abdomen, arms, or fingers, and it measures the glucose concentration in the interstitial fluid of subcutaneous fat rather than the glucose concentration in the blood. It contains a small sensor that continuously measures glucose concentration, and transmits glucose measurements to mobile apps compatible with this device every 5 minutes to trigger an alarm when blood sugar levels rise or fall fall suddenly. When integrated with an automated dosing system, it results in the release of an insulin injector (insulin pump) when blood sugar rises.

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