Beta Bionics Announces Data Lock of the Insulin-Only Bionic Pancreas Pivotal Trial and Enrollment into the Screening Protocol of the Bihormonal Bionic Pancreas Pivotal Trial was released by Beta Bionics on GlobeNewswire.com, 22 December 2021.
Beta Bionics, Inc., a clinical stage medical technology company committed to the design, development, and commercialization of the iLet® Bionic Pancreas System, today announced the completion of the randomized controlled trial for the Insulin-Only Bionic Pancreas Pivotal Trial and enrollment into the screening protocol of the Bihormonal Bionic Pancreas Pivotal Trial at Massachusetts General Hospital. Data lock for the randomized controlled trial occurred last week. Data lock is the process of locking a clinical trial database to prevent further changes to the database. This is also the time when the data are “unblinded” or released to the statisticians who will analyze the data. Public presentation of the clinical data is expected in the first half of 2022.
“Data lock of the Insulin-Only Bionic Pancreas Pivotal Trial represents a major milestone for our organization as we work to bring autonomous insulin-delivery solutions to those living with type 1 diabetes,” said Dr. Ed Damiano, President and CEO of Beta Bionics.
FDA warns about Log4j cybersecurity vulnerabilities in medical devices was published by Greg Slabodkin for HealthDive.com, 20 December 2021.
FDA warned that widespread cybersecurity vulnerabilities in Apache’s Java-based open source logging library could potentially allow unauthorized users to remotely impact the safety and effectiveness of medical device functionality. While FDA said it is not aware of any confirmed adverse events affecting medical devices related to these vulnerabilities, the agency encouraged medtech companies to review and follow the recommendations provided on the Cybersecurity and Infrastructure Security Agency’s website. “As Apache Log4j is broadly used across software, applications, and services, medical device manufacturers should also evaluate whether third-party software components or services used in or with their medical device may use the affected software,” the FDA said in the notice.
Log4j, which is used to log security and performance information, impacts upwards of 3 billion devices that use Java across a variety of consumer and enterprise services, websites and applications, as well as medical devices and supporting systems. FDA said manufacturers who may be affected by the vulnerabilities should communicate with their customers and coordinate with CISA.
Exercise at higher elevation linked to larger drop in glucose with type 1 diabetes was written by Michael Monostra for Healio.com /Endocrinology, 22 December 2021.
People with type 1 diabetes may experience a greater decline in blood glucose when exercising at high altitudes compared with sea level, according to a study published in the Journal of Clinical Endocrinology & Metabolism. In a small study of seven adults with type 1 diabetes, participants experienced a significantly lower blood glucose after 1 hour of exercise in conditions emulating an altitude of 4,200 meters compared with conditions representing sea level.
“These findings suggest that exercise performed shortly after exposure to high altitude may increase the risk of exercise-mediated hypoglycemia,” said Cory Dugan, AFHEA, BSc, a PhD candidate in nutrition and exercise physiology in the school of human sciences at the University of Western Australia in Crawley, Australia.
Cannabis use may cause DKA-like symptoms in type 1 diabetes was reported by Regina Schaffer for Healio.com/endocrinology, 21 December 2021.
Patients with type 1 diabetes presenting with symptoms of diabetic ketoacidosis may instead have ketosis due to cannabis hyperemesis syndrome, and several criteria can help avoid a misdiagnosis, according to data published in Diabetes Care. Physicians mostly rely on pH and bicarbonate levels to diagnose and classify DKA and make floor vs. ICU admission decisions, Halis Kaan Akturk, MD, assistant professor of medicine and pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado and communications director of the American Diabetes Association, Diabetes Technology Interest Group, and colleagues wrote. In a single-center analysis, the researchers found that relying only on pH and bicarbonate can be misleading with cannabis users with type 1 diabetes.
The researchers suggest screening urine toxicology for cannabis in adults with type 1 diabetes who present to the ED with a blood glucose of at least 250 mg/dL, beta-hydroxybutyrate of at least 0.6 mmol/L and a pH of at least 7.4 with bicarbonate of at least 15 mmol/L. “This cutoff would predict 98% of HK-CHS (“hyperglycemic ketosis due to cannabis hyperemesis syndrome”) events,” Akturk said.
Amazon Pharmacy leaders demoted was reported by Erin Brodwin for Axios.com, 17 December 2021.
Amazon Pharmacy leaders TJ Parker and Elliot Cohen have quietly been demoted to roles as consultants for the company, two sources familiar with the matter tell Axios. The leadership shakeup could either be an attempt at hammering out a clearer path forward or a sign of deeper troubles. Parker and Cohen have steered Amazon Pharmacy since 2018 when the tech giant acquired PillPack, their prescription drug startup. Neil Lindsay, the former head of Amazon Prime, has stepped in to oversee Pharmacy and Amazon Care.
High-level staff changes don’t typically occur at Amazon during peak fulfillment and delivery season, which generally runs from Thanksgiving to the first week of January. Despite acquiring PillPack nearly four years ago, Amazon Pharmacy’s share of the overall prescription drug market remains in the single digits, overshadowed by established pharmacy companies like CVS and Walgreens. Several sector analysts say if Amazon Pharmacy wants to change its trajectory, it will need to identify a core customer and clear go-to-market strategy.
Read more: Amazon Pharmacy leaders demoted
Endocrinologists propose diabetes fellowship programs to address growing gap in care was written by Regina Schaffer for Healio.com/Endocrinology, 29 December 2021.
The incidence of diabetes in the United States continues to rise, straining an overburdened health care system that already reflects a shortage of endocrinologists who specialize in the disease. An estimated 34.1 million, or 13%, of U.S. adults have diabetes, according to the most recent CDC National Diabetes Statistics report. Yet of the approximately 7,000 endocrinologists practicing in the U.S., 25% to 30% do not treat diabetes, Boris Draznin, MD, PhD, professor of medicine and director of the Adult Diabetes Program at the University of Colorado School of Medicine, and colleagues wrote in a March 2021 commentary published in Endocrine Practice. The result is approximately one endocrinologist for every 6,500 people with diabetes — and an estimated 80% to 90% of patients heading to a primary care physician’s office for their diabetes care.
“The first problem is the population of people with diabetes is growing,” said Archana R. Sadhu, MD, FACE, director of the system diabetes program and director of transplant endocrinology at Houston Methodist Hospital and assistant professor of medicine at Weill Cornell Medical College, New York. “The second problem is we have had amazing developments in diabetes drugs and technology, but the flipside is the treatment plan is much more complicated. With all these new treatment options, we need experts in diabetes managing patients [but] it is logistically impossible to get an endocrinologist to manage them all. We need to increase the workforce of diabetes experts.”
To address this gap in care, some endocrinologists argue that a multifaceted approach that centers on primary care training in diabetes and its complications is needed. The proposed solution: 1-year diabetology fellowship programs, with funding and accreditation, to train interested family and internal medicine clinicians in intensive diabetes management across the full spectrum of disease.