The U.S. Food and Drug Administration (FDA) has accepted for review Sanofi’s New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin. The acceptance of the NDA follows the acceptance of the marketing authorization dossier for Toujeo by the European Medicines Agency (EMA) for EU countries on May 27, 2014.
Category: Products & Tech
The U.S. FDA approved Mannkind Corporation's Afrezza (insulin human) Inhalation Powder, a rapid-acting inhaled insulin, to improve glycemic control in adults with diabetes mellitus. Afrezza is administered at the beginning of each meal, or within 20 minutes after starting a meal.
In a recent diaTribe interview with David Panzirer and Dana Ball, two of the main figures behind the Helmsley Charitable Trusts’s Type 1 Diabetes program, both men were asked what would be the most important advance in type 1 diabetes over the next five or ten years. Both men answered that improved continuous glucose monitoring technology has the potential to revolutionize the lives of people with type 1 diabetes.
iHealth Lab Inc. has announced the launch of the iHealth Align, the world’s smallest, FDA-approved mobile blood glucose monitor. The meter plugs directly into a smart phone and displays and stores readings using the iHealth Gluco-Smart app...
The U.S. Food and Drug Administration (FDA) has given its approval for the Dexcom G4 PLATINUM Professional continuous glucose monitoring system (CGM). The Dexcom G4 PLATINUM Professional is the only professional-version CGM that offers real-time, unblinded feedback allowing the patient to experience the full benefits of real-time CGM...
Lifebringer is a free, interactive web-based app for type 1 and 2 diabetics, as well as newly diagnosed diabetics, that goes beyond simply tracking blood sugars and organizing numbers input users. It also uses Meehan’s program, called Nagbot, to interact with the user. Nagbot sends encouraging emails to the user over their computer, tablet, or mobile device reminding them to test, or letting them know how they’re doing, and suggesting ways to improve their health. Nagbot, in other words, acts as a helpful companion.
Good news on the blood glucose meter accuracy front: the Diabetes Technology Society (DTS) is beginning work on a surveillance program to ensure that blood glucose meters and strips that have been cleared for sale in the United States continue to meet those accuracy standards even after they’re on the market.
Medtronic has announced the European launch of MiniMed Duo, the world's first two-in-one glucose sensor and insulin infusion set, simplifying integrated insulin pump therapy and continuous glucose monitoring (CGM). MiniMed Duo, which is used with the MiniMed Veo system (the European version of the Minimed 530G), makes it easier for more people with diabetes to benefit from CGM.
Azurite’s idea is based on the fact that an electromagnetic signal, depending on its wavelength, can bounce off a surface and return to its source with a particular pattern reflective of the surface it encountered. Glucose molecules, like any material, reflect a unique electromagnetic signal based on their inherent electrical properties. So Azurite hopes to bounce an electromagnetic signal off the glucose in your blood,
Eli Lilly and Company have announced positive top-line results of three completed Phase III clinical trials in patients with type 2 diabetes for basal insulin peglispro (BIL). Peglispro is being studied as a once-daily treatment for both type 1 and type 2 diabetes. The primary efficacy endpoint of non-inferior reduction in hemoglobin A1c (HbA1c) compared to insulin glargine was met in all three trials.