The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes

Advocates for do-it-yourself release basis “closed loop” automated insulin delivery systems are cheering the publication of a new study in the New England Journal of Medicine that showed that the homemade technology can increase time-in-range in both children and adults with type 1 diabetes.

Open-source automated insulin delivery uses conventional insulin pumps and continuous glucose monitors, but closes the loop between them with automatic insulin-dosing algorithms and apps developed by a willing community of amateurs. The movement is not extremely large, but it is exciting: some 2,700 patients have chosen to trust their diabetes management to the community-developed OpenAps solution without even a hint of regulatory approval.

These citizen-designed programs were the 1st closed-loop systems available for folks with diabetes outside the confines of a controlled trial. And while the diabetes technology firms have been catching up, having released several closed-loop systems, open-source advocates still prefer their homemade tech, which can be updated and improved without the burden of federal oversight.

The consequences were a clear victory for the #wearenotwaiting community; the name is a reference to the group’s vow to take matters into to their own hands and not merely wait until tech companies put approved solutions on the market. While open-source “loopers” have already generated huge amounts of encouraging data through their daily use of the system, some of which has been studied by academics, this is the first time that the tech had been put to such a rigorous examination.

Automated insulin delivery systems from the tech industry, such as the Control-IQ and Omnipod 5, have been shown to work well in previous trials, but this was the first major test of a patient-created system. That the trial was conducted at all is an impressive achievement for citizen science, given the expense that must have been involved. It may also be considered proof that the system can be effective for regular people with diabetes, not just motivated tech-savvy early adopters. Some doctors and patients may be newly convinced that the benefits are legitimate, now that good results have been given the imprimatur of a major medical journal.

The CREATE study, which was performed in New Zealand, was a randomized controlled trial, generally considered the gold standard for such experiments. About one hundred patients were randomized into two groups. The first crew used the open-source loop in tandem with a DANA-i insulin pump and a Dexcom CGM. The other group used similar tech, but without any communication between the two devices: patients had to interpret their own blood glucose values and manually select their own insulin delivery rates. The trial included both children and adults between the ages of 7 and 70. All participants had previously used an insulin pump.

By the end of the trial, the two groups had gone in opposite directions. The loopers improved their glucose control across the board, spending 10% more time in-range, up to 71.2 percent, with an A1C drop of 0.5 percent. The control group, on the other hand, experienced a slight degradation of control. Loopers spent more than three extra hours per day in range, most of which appears to have occurred overnight. The results were basically the same for adults and kids, and no serious problems were associated with looping.

Another insight from the trial: the patients with the lowest time-in-range at the start of the trial were the ones to enjoy the greatest improvements. This suggests that the technology can offer the most help to those who need it most.

Dana Lewis, one of the creators of the open-source system, its extremely first user, and a co-author of the NEJM paper, is likely the most prominent support for the #wearenotwaiting movement. She addressed the learn about results on her website:

These results are not new to those of us using these systems. These results every day are WHY we use and continue to choose each day to use these systems. This study highlights just a fraction of the benefits people with diabetes experience with [automated insulin delivery].

Lewis went on to explain that the study couldn’t capture the many emotional benefits of looping technology, such as the significantly decreased cognitive burden involved with making many fewer glucose management decisions every day.

It should go without saying that there’s an inherent risk to using unregulated and unapproved diabetes technology, and many doctors will frown upon the idea. Nevertheless, we’ll continue to obey the fascinating news in this do-it-yourself diabetes community.

Diabetes Daily

The End of Diabetes: The Eat to Live Plan to Prevent and Reverse Diabetes