Get the app. Do the BBT!
(But don't go out and walk in a hurricane.)
But a bill set to be introduced in the U.S. House of Representatives later this month aims to smooth the agency’s evaluation process. The Healthcare Innovation and Marketplace Technologies Act (HIMTA) would establish a special Office of Mobile Health at the FDA to provide recommendations on mobile health app issues. It would also create a mobile health developer support program at the Department of Health and Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards.
"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Rep. Mike Honda, D-Calif., who is introducing the bill, said in a statement. “Why have the principles of Silicon Valley, which I represent – competition, innovation, and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space.”
Type 1 isn’t all about the numbers. It is about kids living their lives. That said there are one hell of a lot of numbers. We gotta deal with the numbers, so we can love the kids as kids. Nobody need love the numbers.
There are a ton of little electronic machines that produce billions and billions of numbers (and about as many strips on the floor). At times it seems we are floundering in a sea of data points (and strips on the floor). Unfortunately each machine speaks its own language. What we need is the UN. United Numbers.It seems that I am not the part of the diabetes universe that sees data standards as a problem. I recently read two articles that make the case for researchers to have a common diabetes data set. Data Standards in Diabetes Patient Registries (Journal of Diabetes Science and Technology May 2011) and A Strategy of Defining Common Data Elements to Support Clinical Care and Secondary Use in Clinical Research, (AMIA Clinical Research Informatics Summit 2010) both make the case that research would be better off with standards to facilitate data that researches, “collect once, use many times.”
“There were no defined data standards for primary or secondary use in T1D at the start of this project, and so it is likely that the elements we have compiled will be subject to debate and revision when vetted in a broader T1D stakeholder community, which should include perspectives from diabetes care, research, population monitoring, and quality measurement.”
Closed-Loop Insulin Therapy Improves Glycemic Control in Children Aged <7 span="span" years="years">7>
Closed-loop insulin delivery decreases the severity of overnight hyperglycemia without increasing the incidence of hypoglycemia. The therapy is better able to reestablish target glucose levels in advance of a subsequent meal. Younger children with type 1 diabetes may reap significant benefits from closed-loop therapy
October 8, 2012
U.S. FDA Approves the Dexcom G4™ PLATINUM Continuous Glucose Monitor (CGM)
New Device for Diabetes Management is Most-Advanced CGM Available with up to 30% Improvement in Hypoglycemic Accuracy
SAN DIEGO--(BUSINESS WIRE)-- Dexcom(NASDAQ: DXCM), a leader in continuous glucose monitoring, announced today that the U.S. Food and Drug Administrationhas approved its eagerly anticipated new continuous glucose monitoring system, the Dexcom G4™ PLATINUM.
Clinical trials report up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range (i.e., when blood glucose is less than 70mg/dl). The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.
This week Voxiva, which powers the technology behind the federal government’s Text4Baby program, announced the official launch of Care4Life, a mobile-based diabetes education and support program that leverages text messaging, a mobile app and a web portal. HealthInsight, a multi-specialty care delivery network in the Utah Beacon community is currently evaluating Care4Life.
“Since 99 percent of text messages are read and over 90% are read within three minutes, we know that this channel is effective in its ability to pace the delivery of education and reinforce desired behaviors on an ongoing basis,” Voxiva CEO Justin Sims stated, “numerous studies have demonstrated the efficacy of mobile communications in improving diabetes self-management. We know this works and will make people healthier.”