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By Nancy Lapid
Jan 12 – Hello Health Rounds Readers! Several artificial pancreas systems are on the market for people with type 1 diabetes, but the technology has not yet been calibrated for those with type 2 diabetes who eventually need insulin injections to control their blood sugar. This week, a report of a small UK trial suggests that artificial pancreas systems that improve blood sugar control in this larger population are coming closer to reality.
In other news: pretreating some colon cancers with immunotherapy drugs before surgery may yield significantly better outcomes. And U.S. regulations for approving updated medical devices need improvement, two studies suggest.
Artificial pancreas for type 2 diabetes works in small trial
An artificial pancreas to help control blood sugar for people with type 2 diabetes who require insulin is coming closer to reality, researchers reported on Wednesday in Nature Medicine.
In a preliminary trial, 26 patients who used the artificial pancreas saw the amount of time spent with appropriate glucose levels double compared to when they managed their insulin doses on their own.
The artificial pancreas is a fully closed loop system, which means that unlike devices for people with type 1 diabetes, it does not require inputting information about meals and exercise. Instead, it employs an algorithm that predicts patients' insulin requirements. While most of the hundreds of millions of people with type 2 diabetes manage it with diet changes and oral medicines, if not well controlled the disease can progress until insulin becomes necessary.
The experimental system uses an off-the-shelf glucose monitor from Dexcom Inc, an insulin pump from SOOIL Development Co, and an app developed at University of Cambridge, UK.
Participants used the new device for eight weeks. During a second 8-week period without it, they performed their usual fingertip pricks and gave themselves injections.
On average, with the artificial pancreas glucose levels were in the target range 66% of the time and too high 33% of the time. With usual self-care, glucose levels stayed in range only 32% of the time and were elevated 67% of the time.
There were no episodes of dangerously low blood sugar using the system.
The researchers are now planning a larger, longer study and have submitted the system for regulatory approval.
About 90% to 95% of people with diabetes have type 2, which has been linked with obesity. Although it most often develops after age 45, the illness is increasingly occurring in children and young adults.
New approach to colorectal cancers shows 'great promise'
For some patients with early- or mid-stage colorectal cancer (CRC), getting treated first with an immunotherapy drug instead of going straight to surgery might improve the odds of cure and, in some cases, may help them avoid surgery altogether, a study from China suggests.
Some 15% of CRCs contain cells with genetic mutations that contribute to mistakes when the cells divide. Doctors already know that a class of immunotherapy drugs called PD-1 inhibitors, such as Merck and Co's Keytruda and Opdivo from Bristol Myers Squibb, are helpful when tumors with these so called mismatch repair deficient (dMMR) cells have become inoperable.
The new study, published on Wednesday in the Journal of the National Comprehensive Cancer Network, found immunotherapy appears to be even more effective when tumors are at less-advanced stages.
Researchers reviewed data from 2017-2021 on 73 CRC patients scheduled for surgery who received PD-1 inhibitors beforehand. Most had tumors that had begun to invade other nearby tissues. In 17 patients (23.3%), tumors disappeared completely after treatment and did not return. These patients did not require surgery. In 45 patients (61.6%) whose tumors shrank after immunotherapy, 40 later had surgery. All whose tumors disappeared or were surgically removed were alive and free of CRC two years later.
While data reviews are less reliable than formal randomized trials, the researchers said pre-surgery immunotherapy shows "great promise for becoming the new standard of care" for operable CRCs with dMMR cells.
Updated medical devices need better approval process
The U.S. Food and Drug Administration allows medical device manufacturers to market updated versions of their products with little testing and without consideration of whether the earlier version was safe, two studies suggest.
The FDA's so-called 510(k) pathway allows updated medical devices to be commercialized without testing in clinical trials, based on the fact that an earlier version had been approved – even when the earlier approved version itself had not undergone extensive testing or was known to have been recalled.
A study published on Tuesday in JAMA looked at 156 medical devices cleared under the 510(k) pathway from 2017 through 2021 that were later subject to a "Class I" recall because of high risk of serious side effects or death. Overall, 44.1% had been authorized using earlier versions that had also been subject to Class I recalls. The risk of a Class I recall was more than six times higher for updated devices that got 510(k) approval based on an earlier version that also had been recalled, compared with similarly approved devices with recall-free histories, the researchers reported.
In a separate study in the same issue of the journal, a different team of researchers analyzed 35,176 medical devices cleared by the FDA between 2003 and 2018 via the 510(k) pathway. Updated devices submitted for approval based on earlier versions with three or more ongoing recalls had a 9.31 percentage-point increase in recall probability, the study found.
Both teams said better safeguards for the 510(k) pathway are needed to ensure patient safety. (Reporting by Nancy Lapid Editing by Bill Berkrot)
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