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WellDoc/AADE Partner to Promote Digital Diabetes Self-Management Platform

The American Association of Diabetes Educators (AADE), announced today they will partner with digital healthcare company WellDoc to incorporate the “AADE Diabetes Education Curriculum: A Guide to Successful Self-Management” in the BlueStar® digital therapeutic platform. BlueStar® is an FDA-cleared digital therapeutic used to help adults living with type 2 diabetes self-manage their condition. This partnership...
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2016: A Progress Report

progress_shutterstock_226274737 Endocrine science has been at the forefront of research and treatment of a variety of endocrine disorders. The result is a wide array of therapies, products, and more that came to market in 2016, which Endocrine News has compiled here. This past year was the 100th year of the Endocrine Society and it was not...
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FDA Grants Clearance for Digital Application for T2D Patients

The U.S. Food and Drug Administration (FDA) today granted 510(k) clearance for a global digital solution that supports the effective management of type 2 adult diabetes patients treated with basal insulin. The application will be marketed as Insulia® by the company Voluntis, which specializes in therapeutic companion software to help patients self-manage chronic diseases. Insulia® Diabetes Management Companion...
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FDA Grants Clearance for New App-Enabled Blood Glucose Monitoring System

The U.S. Food and Drug Administration (FDA) last week granted 510(k) clearance for a new app-enabled blood glucose monitoring system. Ascensia Diabetes Care The device will be marketed as the CONTOUR® NEXT ONE Blood Glucose Monitoring System (BGMS)  by Ascencia Diabetes Care. The CONTOUR NEXT ONE system features an blood glucose smart meter that links to...
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Positive Results in Phase 2b Study of Metformin Delayed Release in Type 2 Diabetes

Positive results were reported last week in a Phase 2b dose-ranging study, which met the primary endpoint of showing a statistically significant reduction in HbA1c at 16 weeks with delayed-release metformin compared with placebo in subjects with type 2 diabetes. Elcelyx Therapeutics is marketing this drug as Metformin DR, an investigational product designed to target metformin delivery to...
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FDA Approves Hybrid Closed Loop System for People with Type 1 Diabetes

The U.S. Food and Drug Administration (FDA) has approved Medtronic’s MiniMed® 670G system, the first Hybrid Closed Loop insulin delivery system in the world, according to a release from the company. “This significant milestone represents an important step forward in the management of type 1 diabetes and will improve the quality of life for those living with...
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New Clinical Practice Guideline Published on Diabetes Technologies

On September 26, the Endocrine Society issued a Clinical Practice Guideline recommending continuous glucose monitors (CGMs) as the gold standard of care for adults with Type 1 diabetes. The guideline, titled “Diabetes Technology—Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline,” was published online and will appear...
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Caladrius Biosciences Receives FDA Fast Track Designation for CLBS03 to Treat Recent Onset Type 1 Diabetes

Caladrius Biosciences, Inc., announced today that its product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) was granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of type 1 diabetes mellitus (TID), making it the first known therapeutic candidate for treatment of T1D to receive the designation. CLBS03...