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

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. 

The Bigfoot Unity System, which is the centerpiece of the larger Bigfoot Unity Program, is the first and only FDA cleared solution for people with Type 1 or Type 2 diabetes on MDI therapy that directly integrates continuous glucose monitoring (iCGM) data to provide an insulin dose recommendation. The dose, which is based upon instructions from the person’s health care provider, is displayed directly on proprietary, connected smart caps of the person’s disposable insulin pens. Cleared for use by individuals aged 12 and up, the system is designed to clearly, and in real–time help answer the question, “How much insulin would my doctor recommend I take right now?” 

The idea of incorporating technology into insulin management has been a target for many biomedical companies. Bigfoot Unity diabetes management system by Bigfoot Biomedical is very recently granted 510(k) clearance by the FDA. The Bigfoot Unity system is highlighted with the first smart insulin pen cap that operates unique functions which stand out from other devices. Specifically, the Bigfoot Unity is composed of two smart insulin pen caps color-coded differently for different insulins (white cap for rapid-acting, black cap for long-acting), and FreeStyle Libre 2 integrated continuous glucose monitor (iCGM) sensor. The white smartpen cap for rapid-acting insulin can scan the FreeStyle Libre 2 sensor and provides helpful information of: 

• Current blood glucose level, 
• Trend arrows indicating glucose direction (rising quickly, rising, changing slowly, failing, failing quickly),   
• Recommended correction insulin dose, 
• Alert real-time hypoglycemia, 
• Reminder of insulin dosing and timing.  

Bigfoot Smartpen caps also automatically synchronize all the data about glucose serum levels (scanned from FreeStyle Libre 2), consumed insulin doses at specific dates and times to a mobile app on Apple iPhones. This app will then record and deliver these data to the endocrinologists for remote physiologic monitoring without any manual data entry. If symptoms mismatch with glucose readings, finger sticks can be done to verify, especially within the first 12 hours of use. The manufacturer also recommends new users scan their pen caps with FreeStyle Libre 2 every 8 hours repetitively for two weeks to acquire a complete glycemic overview.   

The FDA 510(k) clearance for the Bigfoot Unity system can be considered a milestone in a difficult journey of diabetes management. This unique system saves patients from countless painful finger sticks, confusing insulin dosing calculations along with consequential effects of incorrect insulin dosing leading to hypo/hyperglycemia, and lengthy data recording. The health care providers could also remotely monitor the outcomes of MDI therapy for their patients without going through complicated scheduling for in-person appointments. This is especially beneficial to both the patients and the physicians during the social distancing of the COVID-19 pandemics. These caps are also compatible with major insulin brands in the US, giving flexibility for patients when they change therapy combinations.  

Smart insulin pen caps of the Bigfoot Unity system play an essential role in improving adherence to Insulin therapy and glycemic control, which is the center of diabetes management. Based on deviation patterns of timing and doses at certain times in a day or certain days in a week, uses and their health care providers can decide the most individualized MDI regimen and behavior modification for each patient.  

Bigfoot Unity system also has several limitations. The mobile app that Bigfoot pen caps synchronizes to is only available on Apple iPhones. Other platforms such as Android are not yet supported with the Bigfoot Unity system. Clinicians need to equip themselves with appropriate devices and software to receive data delivered from Bigfoot Unity. The manufacturer also highlighted that their devices could not serve insulin doses in 0.5 units increment, MDI of long-acting insulin, or in patients consuming a high dose of ascorbic acid (vitamin C). With the advance of technology, these limitations are expected to be resolved in the near future. 

Practice Pearls: 

• Bigfoot Smart insulin pen cap and FreeStyle Libre 2 integrated CGM sensor can display the current blood glucose levels and physician insulin correction doses. 
• The Bigfoot system supports remote physiologic monitoring without any manual data entry, enhancing adherence to MDI therapy and providing better glycemic control. 
• Bigfoot Unity™ Diabetes Management System provides tools to your MDI patients to provide insulin dosing instructions. 
• The Program enables you to provide individualized, proactive care at a distance while efficiently managing a large population of MDI patients.  
• The Bigfoot Unity System passively collects glucose and insulin dose time data without intervention from you or your patient. 

“Bigfoot Unity Diabetes Management Program.” Bigfoot Biomedical, Bigfoot Biomedical, May 2021, www.bigfootbiomedical.com/bigfoot-unity. 

Melillo, Gianna. “FDA Clears Bigfoot BioMedical’s Smart Insulin Pen Caps.” AJMC, 10 May 2021, www.ajmc.com/view/fda-clears-bigfoot-biomedical-s-smart-insulin-pen-caps. 

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