What is the iLet Bionic Pancreas?

The iLet Bionic Pancreas is the only insulin pump to require no carb counting, corrections, or calculating of boluses. It uses your body weight to get started and then uses autonomous lifelong learning to calculate and deliver insulin doses. This learning allows it to continually adapt doses to your changing insulin needs.

On May 22, 2023, the FDA approved Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software making way for the sale of this insulin pump to people living in the US.

The Founder

The scope of this effort has spanned nearly the entirety of my son’s life, since he first developed diabetes just days before his first birthday, over 23 years ago…Today we celebrate the dream that the iLet now fulfills.”

ED DAMIANO, PHD, FOUNDER AND EXECUTIVE CHAIRMAN AT BETA BIONICS

The iLet was the dream of Dr. Ed Damiano, PhD, and father of a child with type 1 diabetes. He wanted a much simpler system for his son to use. After many years of hard work and partnerships, the iLet Bionic Pancreas was born.

No carb counting required.

Never before have we seen an insulin pump with does not require the user to count their carbohydrates to bolus.

The iLet Bionic Pancreas, prompts the user to “announce” a meal up to 15 minutes before you eat or as long as 30 minutes after finishing a meal or snack. A meal size of “Usual for Me”, “More”, or “Less” can be chosen. “Usual for me” is the option that you would use for most meals, but if you have 50% more or less carbs, you will choose the “More” or “Less” option.

No basal rates or correction boluses needed.

Just as the algorithms learn how much to bolus for your meals, through their communication with your Dexcom G6, they also can independently determine and command an increase, decrease, maintenance or suspension of all basal insulin doses. According to Marissa Town of childrenwithdiabetes.com, the only setting you have to put into the pump is your body weight. The system learns everything else.

Every 5 minutes, the iLet Bionic Pancreas delivers insulin. If it sees that your glucose levels are dropping too fast or are at an unsafe level, it will decrease or stop your insulin delivery altogether.

According to Beta Bionics, over time, through the iLet’s autonomous lifelong learning, it automatically adjusts your basal rates on the go.

Other Features of the iLet Bionic Pancreas

• It has been approved for use with Novolog or Humalog rapid acting insulin.
• It uses 1.8mL non-refillable glass insulin cartridges.
• This is a rechargeable system. (No batteries are required). A fully charged pump will last for 4-5 days. Betabionics recommends that the iLet be charged while you are bathing or showering. This allows it to maintain optimal battery life.
• The Limited Access feature allows the screen to be locked with a passcode to prevent accidental insulin dosing. This can be helpful when using the pump on small children.
• The iLet operates with a touch screen.
• The display is backlit.
• The iLet will reduce or stop insulin dosing in response to a low or falling CGM levels.
• This system uses Bluetooth technology.
• A mobile app is available that is compatible with iOS platform and Android platform.
• Remote software updates will be available.
• 90 day trial period.

What happens if your CGM fails?

If your continuous glucose monitor goes offline for an extended period, dosing will stop. A countdown timer will appear before dosing stops, however.

You can continue to use your iLet Bionic Pancreas without your CGM for up to 72 hours. The pump will be switched to “BG-run mode” which will continue to deliver a safe level of insulin.

According to the user’s manual, the BG-run mode is “limited to a maximum of 48 hours in the first 7 days after initializing the iLet, and a maximum of 72 hours thereafter. It requires frequent entry of BG values to continue insulin dosing. You will be alerted when BG values need to be entered. After the maximum allowable period (48 or 72 hours), BG-run mode will expire and CGM values are required to resume dosing. When BG-run mode expires and CGM values are not available, ALL insulin dosing will stop. You must switch to alternative therapy as advised by your healthcare provider.”

Who can use this system?

This system is currently only approved for use in the US for individuals with type 1 diabetes aged 6 years and up.

How well does it work?

According to a study published last September in the New England Journal of Medicine, users of the iLet Bionic Pancreas saw an average drop in HbA1c from 7.9% to 7.3% compared with a steady hold at 7.7% for the standard-of-care group over 13 weeks (mean adjusted difference -0.5%, 95% CI -0.6 to -0.3, P<0.001).

Those using the iLet spent on average 11% longer in target glucose range (70 to 180 mg/dL) versus the standard-of-care group, representing a 2.6-hour increase per day. They also spent significantly less time hyperglycemic (above 180 mg/dL) and severely hyperglycemic (above 250 mg/dL).

Drawbacks to the iLet

No insulin delivery system is perfect. You must choose the one that best suits your needs. Here are three things that may deter some people from using this system.

First, there is no exercise mode. The iLet system does not understand exercise at this time. If you are exercising, the manual advises you to either disconnect, ensure that your blood sugars are a little more elevated, or have a snack with you.

Second, the glass insulin cartridges are only 1.8mL in size. For some teens and adults, this may not be as convenient as systems with 3.0mL cartridges.

Finally, this pump is not waterproof and must be disconnected around water.

Other things to know about the iLet Bionic Pancreas

• If you choose to use the iLet Bionic Pancreas, make sure to disconnect before going through an X-ray machine, or having a CT scan, MRI, or PET scan.
• Make sure to disconnect the tubing while on amusement park thrill rides as rapid changes in altitude or gravity can affect the insulin delivery.
• Also, disconnect the tubing before entering an aircraft without cabin pressure or on a plane used for aerobatics or combat simulation for the same reason as above.
• Avoid exposing pump to temps below 40°F (5°C) or above 104°F (40°C).
• Finally, unlike traditional pumps, it is not advised for you to take injections to bring down a high blood sugar reading unless advised by your healthcare provider.

When is it available?

You can contact Beta Bionics directly to work with your insurance provider to purchase this system.