Artificial pancreas improves blood glucose control in young children by 12%
In the NIH-funded Pediatric Artificial Pancreas (PEDAP) Trial, artificial pancreas technology improved blood glucose control in young children between ages 2 and 5 with type 1 diabetes. The study was a 13-week randomized, controlled trial that enrolled 102 participants between ages 2 and 5 at three pediatric diabetes centers across the U.S. The participants were randomly assigned to either the artificial pancreas group or the standard care comparison group. The artificial pancreas, also known as closed-loop control, is a diabetes management system that tracks blood glucose levels using a continuous glucose monitor (CGM) and automatically delivers the insulin when needed using an insulin pump. The system replaces reliance on testing by fingerstick or CGM with delivery of insulin by multiple daily injections or a pump controlled by the patient or caregiver. Participants in the artificial pancreas group spent 12% more time within their target blood glucose range compared to the standard care group. The greatest difference in blood glucose control was seen at nighttime with artificial pancreas participants spending 18% more time in range than the standard care group. More than 80% of the device trainings, and 90% of the study visits overall, occurred virtually, suggesting the suitability of the technology for use in remote and underserved areas.
CDC warns of increasing threat of Candida auris fungus
The Centers for Disease Control and Prevention (CDC) has deemed Candida auris (C. auris), an emerging fungus, as an urgent antimicrobial resistance (AR) threat because it is often resistant to multiple antifungal drugs, spreads easily in health care facilities, and can cause severe infections with high death rates. The fungus spread at a rapid rate in U.S. health care facilities in 2020-2021 and is of greatest risk to people who are very sick, have invasive medical devices, or have long or frequent stays in health care facilities. C. auris has spread in the U.S. since it was first reported in 2016, with a total of 3,270 clinical and 7,413 screening cases reported through December 31, 2021. Clinical cases have increased each year since 2016, with the most rapid rise occurring during 2020-2021. Nationwide, clinical cases rose from 476 in 2019 to 1,471 in 2021. Screening cases tripled from 2020 to 2021, for a total of 4,041. The CDC has continued to see an increase in case counts for 2022. C. auris case counts have increased for reasons including poor infection prevention and control (IPC) practices in health care facilities, strain on health care and public health systems during the COVID-19 pandemic, and enhanced efforts to detect cases, including increased colonization screening.
A phase 1 trial supported by the National Institute of Allergy and Infectious Diseases (NIAID) found that a freeze-dried, temperature-stable experimental tuberculosis (TB) vaccine in healthy adults was safe and stimulated both antibodies and responses from the cellular arm of the immune system. The experimental vaccine, ID93+GLA-SE, is a recombinant subunit vaccine made from four proteins of Mycobacterium tuberculosis bacteria combined with GLA-SE, an immune-stimulating adjuvant. The freeze-dried formulation does not require refrigeration and is mixed with sterile water just prior to injection. The current trial investigated whether administering temperature-stable vaccine containing both ID93 and GLA-SE in a single vial would be as effective at inducing an immune response as a regimen in which non-thermostable ID93 and liquid GLA-SE are held in two vials and combined prior to injection. Twenty-three participants received the thermostable single-vial regimen, while 22 participants received the two-vial, non-thermostable regimen. Recipients of the single-vialled thermostable vaccine had robust T-cell responses and produced higher levels of antibodies in the blood than those receiving the non-thermostable, two-vial presentation. This was the first clinical trial of any subunit TB vaccine candidate in a thermostable form.
Amendment to Mammography Quality Standards Act addresses importance of breast density
The U.S. Food and Drug Administration (FDA) has published updates to regulations issued under the Mammography Quality Standards Act (MQSA) of 1992 to require mammography facilities to notify patients about the density of their breasts. This enforcement will help interpreting physicians better categorize and assess mammograms. According to the Centers for Disease Control and Prevention, about 12.5% of women get breast cancer in their lifetimes, impacting hundreds of thousands of Americans each year. Mammograms are the best method of breast cancer screening and detection. Approximately half of women over the age of 40 in the U.S. have dense breast tissue, which can make cancers more difficult to detect on a mammogram. Additionally, dense breasts have been identified as a risk factor for developing breast cancer. The amendments provide specific language explaining how breast density can influence the accuracy of mammography. They recommend patients with dense breasts talk to their health care provider about breast density, risks for breast cancer, and their individual situation. Helping to promote patient access to information about the impact that breast density and other factors can have on the risk for developing breast cancer is an important part of a comprehensive breast health strategy. The amendments to MQSA ensure the law remains up to date with current science and mammography best practices to improve breast cancer detection and help empower patients.