Health

The US Food and Drug Administration (FDA) has issued a Class I recall for the t:connect mobile app on iOS, which is used to monitor and control the t:slim X2 insulin pump used by people with diabetes. It was supposedly the first smartphone app that can program insulin doses that the FDA had approved. The agency issued the highest level of recall it could, because the app had serious software problems that could've have caused life-threatening conditions or even death. In fact, while there were no mortalities reported, the FDA received 224 injury reports as of April 15. 

According to the agency, version 2.7 of the t:connect mobile app had a bug that initiated a cycle wherein the app would crash and then would be relaunched by the iOS platform again and again. That apparently led to excessive Bluetooth communication that would drain the pump's battery and cause it to shut down earlier than the user would expect. Insulin pumps like the t:slim X2 are designed to automatically deliver insulin under the user's skin at set time intervals and whenever needed. They're supposed to take on the burden of managing the user's sugar levels so that they can go about their day without having to stop and inject themselves or if they're prone to getting hypo or hyperglycemia. 

If a pump shuts down without warning and before the user expects it to, it could lead to the under-delivery of insulin. As the FDA explained in its recall, that could result in hyperglycemia and even diabetic ketoacidosis, a life-threatening complication caused by the inability of the body to turn sugar into energy due to the lack of insulin. Tandem Diabetes Care, the company behind the app and the pump, sent all affected customers an emergency notice back in March. It advised them to update their app, to monitor their pump battery level closely and to carry backup insulin supplies. The FDA's recall notice could reach potentially affected customers who may not have seen the manufacturer's alerts, however, or who may have brushed it aside. Malfunctioning insulin pumps had been linked to multiple deaths in the past, so users may want to keep a close eye on theirs regardless of the brand. 

This article originally appeared on Engadget at https://www.engadget.com/an-insulin-pump-software-bug-has-injured-over-200-people-123056847.html?src=rss

An insulin pump software bug has injured over 200 people   Recently updated !

This entry was posted in Health mobile apps software on by

The US Food and Drug Administration (FDA) has issued a Class I recall for the t:connect mobile app on iOS, which is used to monitor and control the t:slim X2 insulin pump used by people with diabetes. It was supposedly the first smartphone app that can program insulin doses that the FDA had approved. The agency issued the highest level of recall it could, because the app had serious software problems that could've have caused life-threatening conditions or even death. In fact, while there were no mortalities reported, the FDA received 224 injury reports as of April 15. 

According to the agency, version 2.7 of the t:connect mobile app had a bug that initiated a cycle wherein the app would crash and then would be relaunched by the iOS platform again and again. That apparently led to excessive Bluetooth communication that would drain the pump's battery and cause it to shut down earlier than the user would expect. Insulin pumps like the t:slim X2 are designed to automatically deliver insulin under the user's skin at set time intervals and whenever needed. They're supposed to take on the burden of managing the user's sugar levels so that they can go about their day without having to stop and inject themselves or if they're prone to getting hypo or hyperglycemia. 

If a pump shuts down without warning and before the user expects it to, it could lead to the under-delivery of insulin. As the FDA explained in its recall, that could result in hyperglycemia and even diabetic ketoacidosis, a life-threatening complication caused by the inability of the body to turn sugar into energy due to the lack of insulin. Tandem Diabetes Care, the company behind the app and the pump, sent all affected customers an emergency notice back in March. It advised them to update their app, to monitor their pump battery level closely and to carry backup insulin supplies. The FDA's recall notice could reach potentially affected customers who may not have seen the manufacturer's alerts, however, or who may have brushed it aside. Malfunctioning insulin pumps had been linked to multiple deaths in the past, so users may want to keep a close eye on theirs regardless of the brand. 

This article originally appeared on Engadget at https://www.engadget.com/an-insulin-pump-software-bug-has-injured-over-200-people-123056847.html?src=rss

An insulin pump software bug has injured over 200 people   Recently updated !

This entry was posted in Health mobile apps software on by

As learning language models (LLMs) continue to advance, so do questions about how they can benefit society in areas such as the medical field. A recent study from the University of Cambridge's School of Clinical Medicine found that OpenAI's GPT-4 performed nearly as well in an ophthalmology assessment as experts in the field, the Financial Times first reported.

In the study, published in PLOS Digital Health, researchers tested the LLM, its predecessor GPT-3.5, Google's PaLM 2 and Meta's LLaMA with 87 multiple choice questions. Five expert ophthalmologists, three trainee ophthalmologists and two unspecialized junior doctors received the same mock exam. The questions came from a textbook for trialing trainees on everything from light sensitivity to lesions. The contents aren't publicly available, so the researchers believe LLMs couldn't have been trained on them previously. ChatGPT, equipped with GPT-4 or GPT-3.5, was given three chances to answer definitively or its response was marked as null. 

GPT-4 scored higher than the trainees and junior doctors, getting 60 of the 87 questions right. While this was significantly higher than the junior doctors' average of 37 correct answers, it just beat out the three trainees' average of 59.7. While one expert ophthalmologist only answered 56 questions accurately, the five had an average score of 66.4 right answers, beating the machine. PaLM 2 scored a 49, and GPT-3.5 scored a 42. LLaMa scored the lowest at 28, falling below the junior doctors. Notably, these trials occurred in mid-2023. 

While these results have potential benefits, there are also quite a few risks and concerns. Researchers noted that the study offered a limited number of questions, especially in certain categories, meaning the actual results might be varied. LLMs also have a tendency to "hallucinate" or make things up. That's one thing if its an irrelevant fact but claiming there's a cataract or cancer is another story. As is the case in many instances of LLM use, the systems also lack nuance, creating further opportunities for inaccuracy.

This article originally appeared on Engadget at https://www.engadget.com/gpt-4-performed-close-to-the-level-of-expert-doctors-in-eye-assessments-131517436.html?src=rss

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The US Food and Drug Administration has approved the first continuous glucose monitor (CGM) people can buy without a prescription. Dexcom's Stelo Glucose Biosensor System has a sensor users are meant to insert into their upper arm, similar to the company's other CGMs that need a doctor's prescription for purchase. It pairs with a smartphone application that can show the user's blood glucose measurements and trends every 15 minutes. 

The company designed the device specifically for adults 18 and up who are not using insulin, such as those managing their diabetes with oral medications and non-diabetics making a conscious effort to control their sugar intake. It could be a great tool for people with insulin resistance, including individuals with PCOS and other metabolic issues that heighten their probability of developing diabetes in the future. In general, it could give users the insight to be able to better understand how the food they eat and the movements they make impact their overall health. 

While CGMs aren't anything new, they've become a wellness trend on social media last year, and even non-diabetics started using them. By clearing Stelo, the FDA is making the monitors more accessible than before. "CGMs can be a powerful tool to help monitor blood glucose," said Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health. "Today's clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provide. Giving more individuals valuable information about their health, regardless of their access to a doctor or health insurance, is an important step forward in advancing health equity for U.S. patients."

Stelo will be available starting this summer. Each patch is meant to last for 15 days before users will need to replace it. Dexcom has yet to reveal how much it would cost, but it said Stelo will "provide an option for those who do not have insurance coverage for CGM."

A gray circular device.
Dexcom

This article originally appeared on Engadget at https://www.engadget.com/fda-approves-the-first-over-the-counter-continuous-glucose-monitor-130008629.html?src=rss

FDA approves the first over-the-counter continuous glucose monitor

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There’s a reason smartwatches haven’t replaced clinically validated gear when you visit the hospital — accuracy and reliability are paramount when the data informs medical procedures. Even so, researchers are looking for ways in which these devices can...

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