Abbott's Freestyle Libre CGMs Cleared for Use During Imaging Tests

If you use a continuous glucose monitoring (CGM) system, you usually have to remove the sensor before any imaging tests like X-rays, CT scans, and MRIs. But now, Abbott’s FreeStyle Libre 2 and 3 have received the first and only FDA clearance that allows patients to keep their devices on during imaging procedures.TheseCGM devicestrack glucose levels in people with diabetes and alert insulin users when a dose is needed.Before the FDA clearance, patients had to remove their CGM sensor during imaging, often leading to hours of lost data, according toCarol Wysham, MD, a clinical professor of medicine at the University of Washington School of Medicine.People with diabetes are more likely to undergo imaging tests such as CT scans, which can detect kidney stones and blood clots, and MRIs, which provide detailed images to assess heart disease and fatty liver—conditions commonly linked with diabetes.But concerns about imaging affecting medical devices extend beyond CGMs. People with devices like pacemakers or implantable defibrillators often worry about potential damage from scans.It’s crucial for patients to inform their doctors and imaging specialists about any implanted or wearable medical devices to ensure safety, saidMahadevappa Mahesh, PhD, a professor in the Johns Hopkins Medicine Department of Radiology and Radiological Science.FDA Clears the First Implantable Continuous Glucose Monitor That Can Last a YearImaging Tests Could Damage Some Electronic Medical DevicesThe FDA recently released a consumer information page that said interference from radiation during CT scans could damage some electronic medical devices. However, the agency said CT scans continue to be the preferred imaging technology for people with implantable or wearable medical devices.According to the FDA, a wearable device could be damaged if the scanning is aimed directly at the area where the device is located. The likelihood of damage is generally low and can be further minimized if radiation exposure is reduced.“Based on the FDA’s review of available literature, interference is completely preventable when the medical device is outside of the primary imaging area of the CT scanner,” the agency said.The FDA advises patients to discuss any implanted or wearable devices with their radiologist before undergoing imaging or radiation therapy to ensure appropriate precautions are taken.The FDA said it’s not aware of any confirmed interference from other imaging technologies, including X-ray, fluoroscopy, angiograms, or mammograms.For MRIs, medical devices are classified into three categories, which should be listed in the device’s manual:MR safe: The device contains no metal.MR conditional: The device contains metal and a possible energy source, such as a battery. MRI can be safely performed with strict attention to parameters, such as limiting the amount of radiofrequency deposition and the magnet’s field strength.MR unsafe: No adaptations to the scanning parameters can make MRI safe.Types of Glucometers and How to Choose the Best OneHow to Make Sure Your Medical Device Is Safe During ImagingA recent Mayo Clinic study of over 700 patients with implantable devices found that 16% of the records had incomplete or incorrect implant information. Nearly half of these cases had the potential to compromise MRI safety.According to the study, 78% of the errors were due to missing or outdated device manuals. If you receive a wearable or implanted device, you can ask for a link to the digital manuals to keep this information accessible. In case of a recall, you can also find out if your device has been affected.Arash Bedayat, MD, a radiologist with UCLA Health, said if you have a wearable or implanted medical device, you can ask your doctor the following questions before getting an imaging test:What type of imaging will be performed, and why is it necessary?Are there any risks associated with my implanted device and this imaging technique?Can my current medical devices interfere with the imaging results?Are there alternative imaging options available that may not involve radiation?15 Things You Can’t Do With a PacemakerWhat This Means For YouIf you use Abbott’s FreeStyle Libre 2 and 3 CGM systems, this new FDA clearance means you won’t have to remove your sensor during imaging tests like X-rays, CT scans, or MRIs. Before any imaging test, let your healthcare team know about your CGM or other medical devices to ensure they take appropriate precautions and avoid any potential issues during the scan.

If you use a continuous glucose monitoring (CGM) system, you usually have to remove the sensor before any imaging tests like X-rays, CT scans, and MRIs. But now, Abbott’s FreeStyle Libre 2 and 3 have received the first and only FDA clearance that allows patients to keep their devices on during imaging procedures.

TheseCGM devicestrack glucose levels in people with diabetes and alert insulin users when a dose is needed.

Before the FDA clearance, patients had to remove their CGM sensor during imaging, often leading to hours of lost data, according toCarol Wysham, MD, a clinical professor of medicine at the University of Washington School of Medicine.

People with diabetes are more likely to undergo imaging tests such as CT scans, which can detect kidney stones and blood clots, and MRIs, which provide detailed images to assess heart disease and fatty liver—conditions commonly linked with diabetes.

But concerns about imaging affecting medical devices extend beyond CGMs. People with devices like pacemakers or implantable defibrillators often worry about potential damage from scans.

It’s crucial for patients to inform their doctors and imaging specialists about any implanted or wearable medical devices to ensure safety, saidMahadevappa Mahesh, PhD, a professor in the Johns Hopkins Medicine Department of Radiology and Radiological Science.

FDA Clears the First Implantable Continuous Glucose Monitor That Can Last a Year

Imaging Tests Could Damage Some Electronic Medical Devices

The FDA recently released a consumer information page that said interference from radiation during CT scans could damage some electronic medical devices. However, the agency said CT scans continue to be the preferred imaging technology for people with implantable or wearable medical devices.

According to the FDA, a wearable device could be damaged if the scanning is aimed directly at the area where the device is located. The likelihood of damage is generally low and can be further minimized if radiation exposure is reduced.

“Based on the FDA’s review of available literature, interference is completely preventable when the medical device is outside of the primary imaging area of the CT scanner,” the agency said.

The FDA advises patients to discuss any implanted or wearable devices with their radiologist before undergoing imaging or radiation therapy to ensure appropriate precautions are taken.

The FDA said it’s not aware of any confirmed interference from other imaging technologies, including X-ray, fluoroscopy, angiograms, or mammograms.

For MRIs, medical devices are classified into three categories, which should be listed in the device’s manual:

Types of Glucometers and How to Choose the Best One

How to Make Sure Your Medical Device Is Safe During Imaging

A recent Mayo Clinic study of over 700 patients with implantable devices found that 16% of the records had incomplete or incorrect implant information. Nearly half of these cases had the potential to compromise MRI safety.

According to the study, 78% of the errors were due to missing or outdated device manuals. If you receive a wearable or implanted device, you can ask for a link to the digital manuals to keep this information accessible. In case of a recall, you can also find out if your device has been affected.

Arash Bedayat, MD, a radiologist with UCLA Health, said if you have a wearable or implanted medical device, you can ask your doctor the following questions before getting an imaging test:

15 Things You Can’t Do With a Pacemaker

What This Means For YouIf you use Abbott’s FreeStyle Libre 2 and 3 CGM systems, this new FDA clearance means you won’t have to remove your sensor during imaging tests like X-rays, CT scans, or MRIs. Before any imaging test, let your healthcare team know about your CGM or other medical devices to ensure they take appropriate precautions and avoid any potential issues during the scan.

What This Means For You

If you use Abbott’s FreeStyle Libre 2 and 3 CGM systems, this new FDA clearance means you won’t have to remove your sensor during imaging tests like X-rays, CT scans, or MRIs. Before any imaging test, let your healthcare team know about your CGM or other medical devices to ensure they take appropriate precautions and avoid any potential issues during the scan.

2 SourcesVerywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Electronic medical devices, X-ray imaging and radiation therapy: what to know and how to prevent damage.Fahrenholtz SJ, Zhou Y, Sensakovic WF.Frequency and impact of incorrect data when assessing MR safety for patients with active implants.Curr Probl Diagn Radiol. Published online October 3, 2024. doi:10.1067/j.cpradiol.2024.10.010

2 Sources

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.Food and Drug Administration.Electronic medical devices, X-ray imaging and radiation therapy: what to know and how to prevent damage.Fahrenholtz SJ, Zhou Y, Sensakovic WF.Frequency and impact of incorrect data when assessing MR safety for patients with active implants.Curr Probl Diagn Radiol. Published online October 3, 2024. doi:10.1067/j.cpradiol.2024.10.010

Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read oureditorial processto learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.

Food and Drug Administration.Electronic medical devices, X-ray imaging and radiation therapy: what to know and how to prevent damage.Fahrenholtz SJ, Zhou Y, Sensakovic WF.Frequency and impact of incorrect data when assessing MR safety for patients with active implants.Curr Probl Diagn Radiol. Published online October 3, 2024. doi:10.1067/j.cpradiol.2024.10.010

Food and Drug Administration.Electronic medical devices, X-ray imaging and radiation therapy: what to know and how to prevent damage.

Fahrenholtz SJ, Zhou Y, Sensakovic WF.Frequency and impact of incorrect data when assessing MR safety for patients with active implants.Curr Probl Diagn Radiol. Published online October 3, 2024. doi:10.1067/j.cpradiol.2024.10.010

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