At a Glance
- T2D was addressed in 77% of presentations. 21% solely focused on T1D.
- The major theme in line with previous years was Obesity and GLP-1 inhibitors, which are primarily for T2D but increasingly tested for T1D.
- Autoantibody testing for T1D remains a key topic. Breakthrough T1D, ADA, and others publish a definitive guide to set the standard for monitoring people with autoantibodies who have not developed full T1D.
- Vertex (in human trials); SymbioCellTech (approaching human trials); iTolerance & Kadimastem (pre-clinical but generating a lot of buzz).
June 25, 2024
Yesterday marked the end of the American Diabetes Association’s (ADA’s) 84th Scientific Sessions. The annual conference, which took place June 21st-24th in Orlando, Florida, is one of the largest and most significant diabetes research conferences in the world. The Sessions gather thousands of experts, investigators, physicians, and researchers to discuss, debate, and present the latest developments in all aspects of the diabetes arena. The conference is one of the most impactful ventures of the ADA.
This year, there were over 2,000 research projects presented. The main highlights and themes of the convention are summarized below, both in a general context and for T1D specifically.
By the Numbers: T2D Takes Center Stage
T2D was by far the primary topic covered, with 77% of the topics related to T2D. This is consistent with prior years.
By the numbers:
- 57% (1,182) solely concerned T2D.
- 20% (414) dealt with diabetes in general (these most often concerned complications research, diabetes distress, and diabetes management technology seen in Both T1D and T2D).
- 21% (439) solely concerned T1D.
- 2% (51) covered Other conditions (e.g., measuring glucose levels and utilizing CGMs for other conditions, such as insulinoma, acute lymphatic leukemia, polycystic ovarian syndrome, etc.).
Most Discussed Topics: Obesity, Autoantibodies, and Daily Management
1. Obesity and the Continued Rise of GLP-1 Inhibitors
With 42% of US adults being categorized as ‘obese,’ a major cause of T2D, it comes as no surprise that the paramount issue surrounding the Sessions was obesity. This has been the primary focus for several years, but the emphasis on prevention, associated costs, and correlation to T1D has never been higher.
- The ‘Obesity Association’ was announced as a new division of the ADA. The ADA states that this division was formed to reduce the prevalence of obesity and improve resources.
- GLP-1 inhibitors, namely Tirzepatide and Semaglutide, received substantial coverage. These drugs have garnered enormous popularity for general weight management and those with insulin-independent T2D. For those with T1D, there is an increased focus on evaluating the safety and efficacy of these drugs despite historical resistance to GLP-1s as they increase the risk of hypoglycemia.
2. Autoantibody Testing and Early Detection
Many presentations focused on autoantibody testing and the early detection of T1D. Tzield, FDA approved in 2023 as the first drug to delay the onset of stage 3 T1D for upwards of two years, attributed to this greatly. Once an individual tests positive for two or more autoantibodies, their lifetime risk of developing T1D is almost 100%. The importance of screening at-risk individuals and identifying additional autoantibody markers is a rising trend.
One notable topic was the “Consensus Guidance for Monitoring Persons with Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes.” Published jointly by Breakthrough T1D, ADA, the Advanced Technologies & Treatments for Diabetes, and other organizations and clinical experts around the globe, this document provides guidance and direction for healthcare providers to manage and monitor those who have tested positive for islet autoantibodies but have not yet developed stage 3 T1D.
3. Technology, Distress, and Complications
Compared to prior years, there was a definite increase in topics relating to Diabetes Management. A few notable highlights:
- Diabetes technology (insulin pumps, implantable glucose monitors, etc.) for T1D and T2D were widely discussed, as in prior years. However, there was a newfound emphasis on CGMs for regular use—for those without any form of diabetes.
- Presentations surrounding diabetes and its effect on mental health have seen an uptake since last year. Distress managing the disease, social stigma, food insecurity, cost of care, hypoglycemia, and others were addressed repeatedly.
- Long-term complications of diabetes such as neuropathy, cardiovascular health, kidney disease, and others, continue to be a secondary focus in the Sessions throughout the years.
T1D Highlights: 3 Projects to Note
Among the many presentations presented at the conference, three stand out as clearly and specifically on the pathway to a Practical/Functional Cure for T1D, including a solution for cell supply and cell protection.
1. Vertex: T1D Trial Sees Ongoing Positive Results
Vertex Pharmaceuticals announced an update on its phase I/II clinical trial VX-880, testing the effectiveness of Vertex’s embryonic stem cell line with immunosuppressants. After full dosing, twelve patients demonstrated successful islet engraftment and could produce some level of insulin by day 90. All patients experienced improved glycemic control with over 70% time in range. Three patients at their one-year follow-up have reached the secondary endpoint of HbA1c below 7.0% and are insulin independent. In response to ongoing positive data shown in the trial, Vertex has received permission to expand enrollment to thirty-seven total participants.
VX-264, Vertex’s other clinical trial utilizing this same proprietary cell line alongside an encapsulation device, is a complete Practical Cure project. The success of VX-880 cells is a key component impacting the success of VX-264.
2. SymbioCellTech Begins Proof of Concept Study for Future Practical Cure Project
SymbioCellTech announced that it is now seeking IND approval from the FDA to begin a phase I/II clinical trial study. The goal of SymbioCellTech is to deliver a T1D Functional Cure without immunosuppression. The company has created engineered, immune-evasive “Neo-islets” that will be transplanted into patients’ omentum (the fatty layer of tissue covering the stomach). Neo-islets can be made by using islets otherwise discarded.
SymbioCellTech was one of three winners of this year’s Innovation Challenge at the Sessions.
3. iTolerance and Kadimastem Aim to Reverse T1D—Although Still Far from Human Trials
iTolerance generated a lot of buzz during the Sessions after announcing animal-model results of an islet transplantation therapy that aims to be a Functional Cure for T1D without requiring immunosuppressants. The study, taking place at the Diabetes Research Institute (DRI), is a collaborative effort using iTolerance’s iTOL-100 immunomodulary gel to protect Kadimastem’s line of stem cell-derived islets (IsletRx). When assessed in a diabetic immunodeficient mouse model, islets showed successful engraftment, and at the highest IsletRx dose, glucose control improved over three months until normal glucose levels were reached.
A timetable for human trials has not been provided.