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FDA Approves 1st AI Insulin Pen Cap, Making Insulin Dosing Simple

May 18, 2021
Editor: David L. Joffe, BSPharm, CDE, FACA

Author: Thi Vietthi Huynh, 2022 PharmD Candidate, Lake Erie College of Osteopathic Medicine – School of Pharmacy

The FDA cleared The Bigfoot Unity AI Diabetes Management System by Bigfoot Biomedical for T1D & T2D management in patients of 12 or older.  

We all like simple to use things, especially when trying to calculate just how much insulin we need to use at bedtime and for mealtime. Diabetes management is a real challenge due to the inconsistent dosing. Different blood glucose levels and various volumes of carbohydrate intake at one specific time require different insulin doses. Too high of an insulin dose can lead to a fatal glycemic coma, while too low of an insulin dose is not enough to reduce blood glucose level to average. Diabetes management is even more difficult for multiple daily injection (MDI) therapy, which requires two types of insulins (basal and bolus) being injected at different times in a day, and frequency finger sticks for blood glucose level check. People with diabetes also need to record their sugar levels for their endocrinologists to evaluate periodically. These challenges negatively affect adherence to MDI therapy and directly impact the quality of life of people with diabetes....


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