November 14, 2021

New Consensus Report from ADA and EASD on the Management of T1D in Adults, Summarized

reading reportIn late 2021 a new consensus report, The Management of Type 1 Diabetes in Adults, was published jointly by American Diabetes Association (in Diabetes Care) and European Study for Diabetes (EASD) (in Diabetologia). The report was developed by 14 content experts. The focus, interestingly, is on people 18 years of age and older.

 
October 25, 2021

Status Update: Connected Insulin Delivery Devices

Connected Device

Until recently the only ways to take insulin, other than using an insulin pump, was via traditional pens or vial and syringe. Due to engineering and technological innovation there’s a growing cadre of insulin delivery devices called connected insulin delivery devices. In this blog for T1D Exchange, I define “connected” devices and review the rationale for their need.

 
June 10, 2021

A Look Inside the FDA’s Review Processes for Medical Devices

FDA Approved LogoFor years I’ve heard the terms “FDA-approved,” “FDA-cleared,” and “510-k application,” associated with the review of medical devices at the U.S. FDA, but I wasn’t clear on their definitions.

 
May 25, 2021

Bigfoot Unity Cleared and Ready to Step Out: Interview with Jeffrey Brewer, CEO, Bigfoot Biomedical

Jeffrey BrewerI was given the golden opportunity to interview a diabetes care and innovation guru, Jeffrey Brewer, for the T1D Exchange.