The iLet Bionic Pancreas is the Next Step in Autonomous Insulin Therapy

During the Advanced Technologies and Treatments for Diabetes Conference (ATTD) 2022, a group of panelists presented the latest updates in closed-loop technology. Among the panelists was Dr. Steven J. Russell, principal investigator, who highlighted the clinical trial results for the iLet Bionic Pancreas (BP).

What is the iLet Bionic Pancreas?

This screenshot is used with permission from ATTD and Beta Bionics, makers of the iLet Bionic Pancreas.

The iLet BP is a “pocket-sized, wearable investigational medical device designed to dose insulin autonomously.” This means users don’t have to tell the device what to do, aside from entering their initial weight to begin the insulin therapy.

The iLet BP is an integrated delivery system with the algorithm and insulin delivery system in the device that’s about the size of a credit card—a centimeter thick. The device uses glass insulin cartridges. Like other insulin pumps, it is designed to support insulin aspart (fast-acting insulin). 

The iLet BP is for anyone who loves using technology to manage their diabetes and wants to get their hands on the latest innovations, but sadly—it’s not yet available! Currently, the iLet Bionic Pancreas is still in pivotal clinical trial phases and is not FDA-approved.

The iLet BP is one exciting example of the advancements we’ll likely see in the near future in diabetes technology.

What are the benefits of the iLet Bionic Pancreas?

The iLet BP works differently than the insulin pumps available today. Here’s what makes the iLet BP distinct:

• Users simply enter their body weight to start insulin therapy. There are no mathematical configurations and calibrations to get started.
• No insulin regimen parameters (i.e. target blood glucose levels) are entered or needed.
• Users don’t have to count carbs for any meals, set insulin basal rates, insulin-to-carb ratios, or correction factors while using the iLet BP.
• Users don’t even have to determine bolus insulin for meal correction doses! 
• The iLet BP adapts autonomously and continuously to meet individual users’ insulin needs, which also means that users cannot change their insulin doses themselves. And while this may seem scary, the initial clinical trial results are impressive and should offer more relief than worry to people with diabetes.

To date, the iLet BP is the most automated insulin pump technology in development.

Clinical trial results presented at ATTD 2022

Data was shared from a recent clinical study involving 440 adults and children over the age of 6 who live with type 1 diabetes. Beta Bionics, creators of the iLet BP, note that the study population was “more diverse and representative of the U.S. type 1 diabetes population than any previous pivotal trial of automated insulin delivery systems.”

Participants in the study identified within these racial and ethnic categories:

• 74 percent White Non-Hispanic
• 10 percent Black Non-Hispanic
• 10 percent Hispanic
• 6 percent Other/More than one race

Participants in the study were on fast-acting insulin and used the Dexcom G6 continuous glucose monitor (CGM) to measure their blood sugar levels over the 13-week period. The outcomes of this study showed the iLet Bionic Pancreas helps people with type 1 diabetes:

• Reduce A1c levels: After 13 weeks in the study, users who started at a baseline of 7.0% experienced an 0.7% reduction in their A1c.
• No increased risk of hypoglycemia: There was no significant increase in blood sugar levels that dropped below 3.0 mmol/L54 mg/dL in 13 weeks.
• Improved time-in-range: Users experienced an average of 2.6 hours more time-in-range over the 13-week period than those using “standard care.”

What this means for the diabetes community

The iLet BP is designed to help people with type 1 diabetes reduce the mental and emotional burdens of living with the disease. Its creators strive to go beyond what the current insulin therapy device market offers. Though the anticipated time frame for the iLet BP’s FDA approval has not been announced publicly at this time, its benefits and functionality offer a lot of hope for the future of autonomous diabetes devices and technology.