How the iLet Bionic Pancreas changed the course of type 1 diabetes treatment
Today, approximately two million Americans, including 304,000 children and adolescents, have type 1 diabetes (1). For individuals with type 1 diabetes, an autoimmune disease with no current cure, their pancreas does not produce enough insulin to convert and store sugars (2). Type 1 diabetes is associated with a host of other medical complications, and if untreated or improperly treated, it can be fatal (2). Daily treatments for diabetes include wearing a continuous glucose monitor, or CGM, which utilizes a sensor placed beneath the skin that measures blood sugar levels (3). Another available treatment option is the traditional finger prick in which the user places a drop of blood on a test strip that indicates their blood sugar levels (3). Insulin is injected into the bloodstream via syringe or a wearable insulin pump following blood sugar level tests in both treatment options. This is often a long and tedious process associated with numerous calculations (3). To properly handle diabetes, accuracy is a must.
But a new innovation, deemed the “bionic pancreas,” is a promising remedy to the constant mental upkeep associated with regulating blood sugar levels (2). Developed by Ed Damiano, a Boston University professor of biomedical engineering, and co-inventor Firas El-Khatib, the iLet Bionic Pancreas is a “wearable, pocket-sized, automated insulin delivery device” (2). The idea for an automated insulin administration device stems from Damiano’s personal life. In early 2000, when his son, David, was 11 months old, he was diagnosed with type 1 diabetes (2). What followed the diagnosis were tireless days and nights of checking their son’s glucose monitor up to 15 times a day (2). Because most wearable insulin pump devices were not designed for a child of David’s size at the time, Damiano and his wife often had to use trial and error to determine the appropriate insulin dosage (2). Even then, they endlessly monitored David’s glucose levels. Damiano, with his extensive background in biomedical engineering and inspired by his son’s experience, sought out to create a completely automated wearable insulin delivery device.
The iLet Bionic Pancreas administers insulin without needing to calculate carbohydrates.
The iLet Bionic Pancreas functions in tandem with a CGM, and can connect with the glucose monitoring device through Bluetooth (2). Just 15mm thick and about the size of a credit card, the bionic pancreas administers insulin to the body every five minutes via a thin tube connected to the body from the device (4). To get started, the user only needs to enter their weight; the device carries out all the other functions autonomously (5). By contrast, currently available semiautomatic treatments require complicated insulin dosages and routines based on the start of therapy and carbohydrate counting (5). Per Damiano himself, the bionic pancreas is “diabetes without numbers,” with others likening it to a self-driving car (3, 4). Users are easily able to evaluate meals by a qualitative estimate of carbohydrate content (“usual content,” “less,” “more”) along with typical meal type (“breakfast,” “lunch,” “dinner”) (5). The device then draws from an AI-powered algorithm to calculate the appropriate insulin dosage (6). By using data from past glucose levels to calculate current levels and factoring in the body’s reaction to prior insulin deliveries, the bionic pancreas has the ability to adapt to the user’s changing needs (2, 4). Traditional diabetes management methods require patients to calculate the necessary dosage of insulin themselves with help from their doctor (4). Even semiautomated hybrid closed-loop systems, or systems that partially automate insulin delivery, require users to input basal rates, insulin-sensitivity factors, carbohydrate-to-insulin ratios, total daily dose of insulin, and other preparations before they are ready for use (5).
Small enough to fit in a pocket, the iLet Bionic Pancreas is easily portable and wearable.
During a 13-week, multicenter, randomized trial conducted in 2021, researchers found that the glycated hemoglobin levels of individuals using the bionic pancreas decreased from 7.9% to 7.3%, indicating lower blood sugar levels (5). However, individuals using standard care techniques, such as manual insulin injections, did not see a change in their glycated hemoglobin levels, remaining at 7.7% over the course of the 13-week trial (5). While the current glycated hemoglobin goal is under 7.0%, less than 20% of people living with type 1 diabetes meet that goal, further characterizing the improvement as a “clinically significant reduction” (5, 4). In addition to lower glycated hemoglobin levels, trial participants using the insulin-only bionic pancreas were observed to have a lower mean glucose level, spent 2.6 more hours per day in the target glucose range, and spent less time in a hyperglycemic state (5). These improvements were reflected in both the pediatric and adult trial participants.
Researchers deduced that qualitative meal feedback alone can contribute to well-controlled glycemic levels (5). The trial results also suggested that controlled glycemic levels do not require an insulin routine as previously indicated, among other factors (5). Of the adverse events reported by bionic pancreas users, participants most frequently experienced hyperglycemia, or high blood sugar, often the result of infusion-set failure (5). There were no significant differences in the rate of severe hypoglycemia events between the standard care and bionic pancreas groups (5).
The iLet Bionic Pancreas, which has been commercially available since 2023, recently received approval from Medicare and Medicaid. Today, this technology is more accessible for individuals with type 1 diabetes (2, 6). Damiano, on the other hand, while satisfied, is not done yet. He is currently working to develop a bihormonal version of the iLet Bionic Pancreas that supplies the wearer with both insulin and glucagon, a hormone that raises blood sugar levels (3). For now, we can be sure that the quality of life for individuals living with type 1 diabetes is steadily improving and going to continue its upward trajectory in the future.
Bibliography:
- Statistics About Diabetes | ADA. (2021). Diabetes.org. Retrieved from https://diabetes.org/about-diabetes/statistics/about-diabetes
- FDA Clears Bionic Pancreas Developed in BU Lab for People with Type 1 Diabetes. (2023, May 24). Boston University. Retrieved from https://www.bu.edu/articles/2023/fda-clears-bionic-pancreas-for-type-1-diabetes/
- Bouranova, A. (2023, July 24). How the iLet Bionic Pancreas Could Revolutionize Type 1 Diabetes Management. Boston University; The Brink. Retrieved from https://www.bu.edu/articles/2023/how-a-bionic-pancreas-could-revolutionize-type-1-diabetes-management/
- Thurston, A. (2022, September 29). Bionic Pancreas Better for Managing Type 1 Diabetes. Boston University; The Brink. Retrieved from https://www.bu.edu/articles/2022/bionic-pancreas-better-for-managing-type-1-diabetes/
- Russell, S. J., Beck, R. W., Damiano, E. R., El-Khatib, F. H., Ruedy, K. J., Balliro, C. A., Li, Z., Calhoun, P., R Paul Wadwa, Buckingham, B., Zhou, K., Daniels, M., Raskin, P., White, P. C., Lynch, J., Pettus, J., Hirsch, I. B., Goland, R., Buse, J. B., & Kruger, D. (2022). Multicenter, Randomized Trial of a Bionic Pancreas in Type 1 Diabetes. New England Journal of Medicine, 387(13), 1161–1172. Retrieved from https://doi.org/10.1056/nejmoa2205225
- Stokel-Walker, C. (2023, October 24). Accurate Insulin. Time. Retrieved from https://time.com/collection/best-inventions-2023/6324392/ilet-bionic-pancreas/?utm_campaign=bu_today&utm_source=email_20231026&utm_medium=intrograph&utm_content=research_medicine
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