Bigfoot Unity™ Diabetes Management System

      FDA has granted 510(k) clearance for first-of-its-kind Bigfoot Unity™ Diabetes Management System, which features connected smart pen caps that recommend insulin doses for people using multiple daily injection (MDI) therapy. The Bigfoot Unity smartpen caps provide on-demand, insulin dose decision support to minimize guesswork and enable patients to follow their doctor’s instructions in a convenient, simple way. Integrated with Abbott’s FreeStyle® Libre 2 system, the Bigfoot Unity System is the first and only system to translate continuously monitored glucose data into on-demand insulin dose recommendations displayed right on the pen-cap screen for ease of use. This is also the first and only FDA-cleared dose decision support system with real-time hypoglycemia alerts and compatible with all major U.S. brands of rapid- and long-acting disposable insulin pens. It is cleared for use by individuals aged 12 and up. The system possesses features to upload iCGM and dose-time data without manual intervention from the patient or the health care provider to enable ongoing, proactive patient care through remote physiologic monitoring.

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CGM use aids in less staff exposure to COVID-19

      Blood glucose monitoring is an inevitable part of diabetes management in individuals with diabetes. COVID-19 pandemic brings forth the greatest hurdle to the frontline health care workers in hospitals who closely interact with patients for various laboratory tests such as measuring the patient’s blood glucose. The close contact with patients raises mental agony among the health care professionals about protecting their health and well-being during the pandemic.

      In April 2020, the FDA allowed the use of CGM devices in hospitalized patients. Followed by this announcement from the FDA, several hospitals had adopted the use of CGM in their practice by incorporating the apparatus and performing the appropriate training to make the staff feel comfortable using the new technology. This new practice minimized the use of PPE while providing the best care to the patients. Studies that analyzed the efficacy of CGM showed that CGM was accurate and beneficial in monitoring blood glucose levels and in detecting hypoglycemia and hyperglycemia events. The results are promising and assure the safety of health care professionals while managing glycemia and reduce PPE use.

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FDA approves diabetes drug Wegovy (semaglutide) for chronic weight management

      FDA approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition such as high blood pressure, type 2 diabetes, or high cholesterol, along with a low-calorie diet and increased physical activity.

      The safety and efficacy of Wegovy were studied in four 68-week randomized, double-blind, placebo-controlled trials. Individuals with diabetes who received Wegovy lost 6.2% of their initial body weight and those without diabetes who received Wegovy lost an average of 12.4% of their initial body weight compared to those who received placebo.

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