The American Diabetes Association (ADA) hosted its 82nd annual Scientific Sessions last weekend. It’s one of the year’s most important events for T1D research, bringing together many of the top researchers from around the world to publish and discuss their latest findings.
As in prior years, the focus of the conference was primarily on type 2 diabetes. Based on our analysis of 1,331 published abstracts, 75% addressed type 2 diabetes (1,001 abstracts) while 25% directly addressed type 1 diabetes (330 abstracts). However, a few key storylines emerged throughout the weekend relevant to the development of a Practical Cure for people living with T1D today.
Several presentations focused on the main hurdles hindering the progress of islet cell transplantation: namely, cell supply and cell protection. Many researchers also shared excitement about the next generation of diabetes devices which may bring us closer to the goal of a fully closed-loop system that a user can simply “set and forget.”
Multiple Shots on Goal for a New Supply of Insulin-Producing Cells
- Vertex Pharmaceuticals shared time-in-range data for the two patients who received half doses of VX-880 – the line of stem-cell-derived insulin-producing cells the company is testing in human trials – alongside immunosuppression.
- Patient #1 spends 99.9% of his days within the target blood glucose range without taking any insulin 270 days after receiving the treatment.
- Patient #2 spends 52% of their time in range while taking 30% less insulin 150 days after receiving the treatment.
- While both data points are groundbreaking in the field of stem cell therapies for T1D, the variation in these results underscores the need for further human testing.
- Vertex Pharmaceuticals and ViaCyte, the two companies that have published results in humans of their stem-cell-derived islet cells, are viewed as the leaders of the pack in the field of stem-derived islets.
- Stem cells are not the only possible “next-gen” source of supply for islet cell therapy. Another source of cells called xenotransplantation – the transplantation of organs across species – also received attention at the conference. In particular, there was discussion regarding the potential of using pig islets to serve as a suitable supply of insulin-producing cells for T1D. But this research is not currently active in human trials.
The Challenges of Cell Protection
- A lot of work has gone into encapsulating insulin-producing cells within an immunoprotective membrane or device. However, nobody has figured out how to keep implanted cells alive without the use of anti-rejection drugs and full-body immunosuppression – a fact that was noted several times as a yet unsolved major barrier to a Practical Cure for T1D.
- Several researchers expressed excitement about the active ViaCyte-CRISPR Therapeutics clinical trial, which tests a line of stem cells that has been edited with CRISPR-Cas9 technology to be hidden from the immune system. No new data was presented about this trial, which just started at the beginning of the year.
Device Improvements: How Close are we to Set-it-and-Forget-It?
- Beta Bionics shared solid performance data from a 440-person trial of its iLet Bionic Pancreas. The “closed-loop” insulin pump system is distinguished from the ones currently in the market because it requires less data input and interaction from the user. Click here to read more about the results.
- Beta Bionics announced in December that it would begin recruiting patients for a clinical trial of its much-discussed dual-hormone device. No clinical updates of this trial were reported at the conference.
- Insulet, which received FDA approval to market the Omnipod 5 system to people ages 6 and up at the beginning of the year, shared strong new data from a clinical trial in children ages 2-6 years old. The Omnipod 5 is the only tubeless artificial pancreas approved for use in the US.
- Abbott announced it received FDA approval for its Freestyle Libre 3 continuous glucose monitor (CGM) – which is the size of two pennies stacked on top of each other – just days before the ADA Sessions began.
- In an exclusive interview with Medtech Dive, Dexcom’s CEO said that he “does not have a date yet” when its next-generation CGM (the Dexcom G7) would be approved.
Other Notable Highlights
- The Faustman Lab at Massachusetts General Hospital shared a poster detailing how they think the Bacillus Calmette–Guerin (“BCG”) vaccine might work to reverse T1D. The lab is currently enrolling juvenile patients with T1D to test the vaccine’s ability to reverse T1D and restore beta-cell mass.
- Sernova, which recently announced a partnership with Evotec to develop an unlimited supply of insulin-producing cells from stem cells, shared data from its ongoing trial of cadaverous islets implanted into immunosuppressed patients. Three patients have been completely insulin-independent for two years, six months, and three months.