Dexcom to resubmit G7 glucose monitor software for FDA review, pushing back US launch was posted by Conor Hale for FierceBioTech.Com, 29 July 2022.
Diabetes tracker developer Dexcom is pushing back the timeline for a U.S. launch of the latest generation of its continuous glucose monitor, the G7 after the FDA raised questions about the device’s software during a review. Though the wearable sensor was first submitted to the agency late last year, the company now plans to rework how the G7 and its smartphone apps deliver alarms to alert the user of significant changes in their blood sugar.
“We discussed several options that we had, and we decided the best option at this time was to revise the software and file it differently and we have added a few other features to it as well based on our discussions with them,” CEO Kevin Sayer. Comparing the latest version to its mainstay G6, the G7’s development had already brought on a complete revamp of the company’s processes.
“We changed the algorithm. We changed the insertion techniques. We changed every manufacturing procedure that we have and completely rewrote the entire app and the software experience, which is a lot for [the FDA] to digest and a lot for us to submit,” Sayer said.
New study adds to growing evidence that immune system may not be source of Type 1 diabetes was reported by Max Bayer for FierceBioTech.com, 5 July 2022. Researchers at the University of Chicago have identified a potentially critical gene tied to Type 1 diabetes disease progression.
According to a new study published in Cell Reports, knocking out or deleting the gene Alox15, which produces the enzyme 12/15-Lipoxygenase, triggered a cascade of benefits in mice. Specifically, eliminating the gene helped preserved beta cells, which produce insulin in the pancreas, and reduced the amount of infiltrating T cells that, ultimately, prevented Type 1 diabetes from forming. Alox15 is predisposed in people with Type 1 diabetes, and 12/15-Lipoxygenase is associated with inflammation in beta cells.
“When we got rid of this gene, the beta cells no longer signaled to the immune system and the immune onslaught was completely suppressed, even though we didn’t touch the immune system,” said senior author Raghavendra Mirmira, M.D., Ph.D. “That tells us that there is a complex dialogue between beta cells and immune cells, and if you intervene in that dialogue, you can prevent diabetes.” Mirmira is a professor of medicine at the University of Chicago and director of the university’s Diabetes Translational Research Center.
Let’s meet Abvance Therapeutics, a pre-clinical stage start-up developing a titratable, fixed-ratio combination of two well-understood and FDA-approved peptides to control glycemia while mitigating the threat of hypoglycemia.
Alan Cherrington PhD, a researcher at Vanderbilt University, discovered that it is feasible to deliver insulin and glucagon together in a fixed concentration ratio. It is known that the actions of the two peptides are opposing: insulin lowers blood glucose while glucagon raises blood glucose (and is the foundation for emergency rescue from hypoglycemia). His discovery is founded on the observation that the actions of insulin and glucagon, when given together, are glucose-dependent. The hormones act in concert for improved glycemic control and protection from hypoglycemia when co-administered at a critical concentration ratio.
The goal: Patients who use the Abvance combination product, in place of insulin alone, will be able to experience improved blood glucose control with a safety buffer against hypoglycemia. This would not require some new behavioral change or device enablement and will lighten the daily burden of their disease management.