Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.
Glooko Inc. and Hedia ApS launched an integrated software solution in the U.K. to support people with diabetes who require advanced doses of bolus insulin. The solution combines Glooko’s diabetes monitoring platform with Hedia’s diabetes dosing recommendation app to deliver personalized insulin dosing advice to people with type 1 and type 2 diabetes.
Dexcom Inc. put real money behind expanding its integration efforts, with a $75 million investment in the $200 million series D for Ōura Health Oy, the maker of the Ōura smart ring. Ōura and Dexcom also provided details on a strategic partnership that integrates data from Dexcom’s continuous glucose monitors with vital sign, sleep, stress, heart health and activity data from the Ōura ring.
Novo Nordisk A/S’s once-weekly human insulin analogue for adults with type 1 diabetes mellitus could be a useful tool for patients and physicians, the U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee said May 24, but it also agreed that the risks outweighed the benefits for improving glycemic control.
Once-daily insulin treatment is getting a challenge from Novo Nordisk A/S’s once-weekly option. The U.S. FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meets Friday, May 23, to review the BLA for once-weekly Awiqli (insulin icodec), a human insulin analogue from Novo for adults with type 1 diabetes mellitus.
Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.
Reports of the death of the market for continuous glucose monitors in individuals with type 2 diabetes are greatly exaggerated, Abbott Laboratories studies show. Far from being unnecessary given the enthusiastic uptake of GLP-1 drugs, the devices significantly improve blood glucose control regardless of the drug used, duration of SLP-1 therapy or use of insulin, presentations at the International Conference on Advanced Technologies & Treatments for Diabetes in Florence, Italy, demonstrated.
In a grand slam for Dexcom Inc., the U.S. FDA cleared its Stelo glucose biosensor system for over-the-counter marketing, making it the first integrated continuous glucose monitor available without a prescription. Designed for use by the 25 million adults with diabetes who do not use insulin and do not have problematic hypoglycemia, the FDA indication expanded the clearance for Stelo to include individuals without diabetes “who want to better understand how diet and exercise may impact blood sugar levels,” dramatically expanding the market opportunity.
Osang Healthcare Co. Ltd. is attempting a second listing on the Kosdaq market with an IPO, planned sometime in March, to fund the company’s growth beyond the COVID-19 pandemic.
