Debate On Glucose Control Continues As NICE-SUGAR Results Come In
This article was originally published in The Gray Sheet
Executive Summary
The NICE-SUGAR trial shows that intensive glucose control led to higher mortality rates than conventional control in adults in intensive care units, but experts are cautioning against changing clinical practice until further analyses are available
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FDA Holds Up Edwards-DexCom Continuous Glucose Monitor For Hospital Use
Edwards Lifesciences' and DexComs’ first-of-its-kind continuous glucose monitor for hospital use is running into delays at FDA.
FDA Holds Up Edwards-DexCom Continuous Glucose Monitor For Hospital Use
Edwards Lifesciences' and DexComs’ first-of-its-kind continuous glucose monitor for hospital use is running into delays at FDA.
Edwards Lifesciences
Firm will launch the first continuous glucose monitor developed under an agreement with DexCom in Europe later this year, pending positive results from ongoing clinical studies, CEO Michael Mussallem says during an April 27 first quarter earnings call. Edwards signed a deal in November to license DexCom technology to create hospital-based CGMs. The company agreed to pay $13 million upfront and will pay up to $24 million over the next three years for product development and regulatory approval milestones. DexCom also will receive either a profit-sharing payment of 10% or royalty of up to 6% of commercial sales. Some analysts have questioned Edwards' ability to bring glucose monitors to the hospital setting in light of results from the NICE-SUGAR study, which showed rigorous glucose control led to a higher mortality rate in intensive care patients (1"The Gray Sheet" April 13, 2009, p. 12). Mussallem conceded the results are "likely to have some impact" on the firm's efforts to commercialize CGMs, but maintained that they also underline the need for accurate glucose monitoring