Beta Bionics Shares Clinical Trial Data on Bionic Pancreas for Type 1 Diabetes

Earlier this month, Beta Bionics presented clinical trial data to the American Diabetes Association (ADA) on its insulin-only bionic pancreas — called the iLet Bionic Pancreas — for use in treating type 1 diabetes (T1D).  

Although the first bionic pancreas was approved by the FDA in 2016, its development was catalyzed by a group of Health Hackers who identified the need for easier T1D management and care. Members of the diabetes community banded together, empowered by the #WeAreNotWaiting movement, to develop a DIY artificial pancreas using their already present insulin pumps.  

Since then, pharmaceutical and med-tech companies have been looking for ways to improve or advance the efficacy of the artificial pancreas.  

Type 1 diabetes — sometimes referred to as insulin-dependent or juvenile diabetes — is characterized by the inability of the pancreas to produce any or a sufficient amount of insulin. According to a study done in 2020, 15 out of every 100,000 people worldwide have T1D, and that number continues to increase.  

The study highlighted at the ADA conference emphasizes that addressing high blood glucose levels in diabetic patients often leads to hypoglycemia. To mitigate and monitor that, the study uses the iLet pancreas.  

It states that “the iLet bionic pancreas (Beta Bionics, Inc.) is a purpose-built, fully integrated device that receives a signal from a continuous glucose monitor (CGM) and contains autonomous, lifelong learning, mathematical dosing algorithms, which are initialized only with the patient’s body weight.” 

In its press release, Beta Bionics claims that using the iLet bionic pancreas reduced HbA1c by 1%. They go on to describe the psychological benefits of product usage, stating that both adult patients and parents of pediatric patients cited less stress associated with potential hypoglycemic episodes.  

This study expands on its previous clinical trials by diversifying the T1D patient population. Furthermore, the researchers separated patient populations into subgroups based on racial, socioeconomic, and educational background, allowing them to analyze how this product impacts the social determinants of health.  

The press release sheds light on the amount of mathematics involved in T1D care and how it often leaves room for error. “As a nurse practitioner and diabetes care and education specialist, I have always said a diagnosis of diabetes does not come with a math degree,” said Jeanne Jacoby, FNP, CDCES, Director of Medical Affairs, Beta Bionics, in the report.  

What distinguishes iLet from traditional insulin pumps is that it only requires a patient’s weight to set up. There are no necessary calculations or insulin dose inputs. Beta Bionics has not yet received approval from the FDA for commercial sale but will continue to conduct and present research on the product.