- A “bionic pancreas” developed by Beta Bionics performed better than the standard of care in reducing hemoglobin A1c levels, according to results published in the New England Journal of Medicine on Thursday.
- The results indicate that the automated device and others like it could improve diabetes treatment, especially for patients who don’t live near an endocrinologist, according to an editorial also published in the journal.
- Patients who used a bionic pancreas saw their HbA1c levels decrease from 7.9% to 7.3% after 13 weeks, while the standard of care group did not see any change, the study found.
The iLet bionic pancreas used in the study is worn like an insulin pump and doesn’t require carbohydrate counting or rate setting, unlike other automated tools. It was developed by Ed Damiano, a Boston University professor whose son has Type 1 diabetes, and the device was later spun out into a startup called Beta Bionics.
The results point to potentially improving access to diabetes treatment, especially for patients who don’t live near an endocrinologist, according to the editorial.
“Although primary care providers may be eager to offer the best tools, the complexity of the available systems to date has not infrequently impeded prescription,” the authors of the editorial wrote.
For the 13-week trial, 219 patients with Type 1 diabetes were given a bionic pancreas and 107 continued with the standard of care, which involved using a continuous glucose monitor and any method of insulin delivery.
The device met its primary endpoint in the study of reducing patients’ HbA1c levels, while there was no difference between the two groups in the secondary endpoint, or the percentage of time patients’ glucose levels were below 54 mg per deciliter. Patients who used the bionic pancreas also had a higher rate of severe hypoglycemia than the standard of care group, at 17.7 events per 100 participant years.
So far, just a handful of automated insulin delivery systems have been approved for use. In the U.S., three such devices have received approval from the Food and Drug Administration, while in Europe five have received a CE mark.