Medtronic received the go-ahead to begin an at-home U.S. trial of its Low Glucose Suspend technology that aims to prevent hypoglycemia by automatically stopping basal insulin delivery when measured glucose reaches a critically low level.
The pump technology is already available in Europe on the company’s Paradigm Veo insulin pump.
This is the second phase of the ASPIRE (Automation to Simulate Pancreatic Insulin REsponse) study, following the completion of the in-patient clinical study. ASPIRE is a multi-center, randomized, pivotal in-home study being conducted at multiple investigational centers to determine the safety and efficacy of the Low Glucose Suspend feature in the sensor-augmented MiniMed Paradigm insulin pump. Medtronic’s newest continuous glucose sensor, the Enlite™ sensor, will be tested as part of the overall system.
ASPIRE will compare Read more »
*This blog post was originally published at Medgadget*
I just finished our first day at the Principle Investigator Meeting for the launch of the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial in Philadelphia today. The trial is a 3000-patient patient trial performed at 140 centers around the world and jointly sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a component of the National Institutes of Health (NIH), and industry (St. Jude Medical and Biosense Webster).
The trial will randomize 3000 previously untreated or incompletely treated patients at high risk of cardiovascular complications in the trial to two arms: 1500 patients to catheter ablation as primary therapy of atrial fibrillation and the other 1500 patients to conventional medical therapy with rate control or rhythm control strategies to determine if catheter ablation is superior to medical therapy at reducing total mortality (the primary endpoint). Secondary endpoints of a composite endpoint of mortality, disabling stroke, serious bleeding, or cardiac arrest will also be studied.
If done properly, this study stands to be a landmark trial for the field of cardiac electrophysiology and has huge ramifications for the treatment of patients with atrial fibrillation. Also, it doesn’t take a lot of rocket science to know that the government will be looking closely at the results of this trial to determine which treatment strategy will receive government funding. Read more »
*This blog post was originally published at Dr. Wes*