The artificial pancreas system, called Control-IQ and manufactured by Tandem Diabetes Care, tracks blood glucose levels with a continuous glucose monitor Dexcom G6 CGM and automatically delivers the hormone insulin as needed. The system frees people from testing their blood sugar levels multiple times a day by fingerstick, and from delivery of insulin by multiple daily injections.
FDA approval follows results from a multicenter clinical trial published in the New England Journal of Medicine that found the new artificial pancreas system was more effective than existing treatments at controlling blood glucose levels in people with type 1 diabetes. This prevents them from interacting with other molecules and thus insulin arrives faster to the bloodstream. Another challenge with insulin is making more concentrated formulations that allow the next generation of artificial pancreas devices to become smaller.
Insulin alone is unlikely to be enough to adequately regulate blood sugar levels in a fully automated artificial pancreas. After all, it is not the only hormone involved in regulating blood glucose in healthy people. One candidate is amylin, a hormone that is secreted by the same cells that produce insulin.
Altogether, amylin makes insulin work better. With the help of pramlintide — an injectable form of amylin — Haidar expects we can get significantly closer to a fully automated artificial pancreas. Currently, people with type 1 diabetes have to count the carbohydrates in each meal to calculate how much insulin they need.
We think we can get there with pramlintide. Although pramlintide is already available, the challenge for an artificial pancreas is having a formulation of insulin and amylin together. Adocia is using its shielding technology to develop such a combination of insulin and pramlintide. In a first trial in humans, the formulation proved to reduce the spikes in blood sugar after a meal when compared to a conventional insulin treatment.
Glucagon is also likely to be a key piece in creating a fully automated artificial pancreas, especially for those that experience bigger swings in glucose levels. The problem with glucagon is that it is unstable in liquid form. Currently it is only available as a powder that needs mixing and is only intended for emergencies where the blood sugar levels go dangerously low. This six-month study was the third phase in a series of trials. It was conducted with participants living their usual day-to-day lives, so the researchers could best understand how the system works in typical daily routines.
This iDCL protocol enrolled participants age 14 or older with type 1 diabetes. They were randomly assigned to use either the artificial pancreas system called Control-IQ or sensor-augmented pump SAP therapy with a CGM and insulin pump that did not automatically adjust insulin throughout the day.
Participants had contact with study staff every two to four weeks to download and review device data. No remote monitoring of the systems was done, so that the study would reflect real-world use.
Artificial pancreas users also showed improvements in time spent with high and low blood glucose, hemoglobin A1c , and other measurements related to diabetes control compared to the SAP group. During the study, no severe hypoglycemia events occurred in either group. This futuristic technology is now officially being referred to as AID Automated Insulin Delivery systems, and they are getting very close to truly changing the game for people whose lives depend on insulin.
Other companies are working on versions that may be available soon. Meanwhile, a vibrant D-patient do-it-yourself DIY community has been developing their own homemade versions that are becoming widely used across the country.
Although Artificial Pancreas AP sounds like a single appliance that you would just plug into your body, the fact is: we are not there yet. The monitor is controlled via a receiver currently a separate handheld device, but in the future could be a smartphone mobile app using sophisticated software algorithms to make the whole thing work.
The idea is to automate blood glucose BG control as much as possible, so the wearer no longer has to take fingerstick blood sugar readings and then calculate how much insulin to dose or reduce based on readings.
Some systems can even shut off insulin delivery automatically based on low blood sugar readings detected by the CGM. And some systems are experimenting with carrying glucagon in the pump alongside insulin, to bring blood sugar up when necessary. Incredible strides are being made, and new groups and companies seem to be emerging to work on this exciting advancement in diabetes technology. Medtronic offers financial assistance to patients in need. The newer Tandem Control-IQ system is being offered as a free software update for in-warranty t:slim X2 pump users in the U.
Existing users can access the upgrade through the Tandem Device Updater , which is simply plugged into a computer with a micro-USB cable. Some new AP systems are expected to hit the market by mid to late , with many options to follow in the next few years. Specific price tags for newer systems are not yet available, but should not exceed the cost of the insulin pump and CGM currently used.
There is no single inventor to thank but rather a whole host of companies working on developing a market-ready AP system. They include, in alphabetical order:. Ed Damiano and team have been working on Beta Bionics for more than a decade.
This dual-chambered device with a sophisticated user interface will include pre-filled cartridges of insulin and glucagon to eliminate the need for manual filling by the user. It is expected to be released by Bigfoot also acquired Timesulin to create a smartpen version of their automated insulin delivery AID system, alongside the pump version.
You can read the origin story here. Diabeloop is a European pump company and French research consortium developing and testing new AP systems in the United Kingdom and France. It was using the Kaleido hybrid patch-tubed pump in its first developed version, but since that device has been discontinued Diabeloop has been working to integrate other pump technology — such as the Roche Accu-Chek system.
The leading CGM sensor technology from the San Diego-based Dexcom is at the heart of a large majority of AP systems under development, including some DIY systems being cobbled together by citizen hackers.
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