#48 - 🔬 Teplizumab's big trial is here

Hey readers! 👋

Welcome back to another week of T1D news. This week's lineup is packed: we've got new data on teplizumab from a major phase 3 trial, stem cell research inching closer to the clinic, implantable CGMs pushing the boundaries of what "long-term" means, an oral vaccine trial out of Australia, and a timely warning about trusting AI with your carb counts. Let's dig in.

Teplizumab and Beta-Cell Function in Newly Diagnosed Type 1 Diabetes - The PROTECT trial results are now published in the New England Journal of Medicine, and they paint a nuanced picture. In children and adolescents with newly diagnosed T1D, two 12-day courses of teplizumab significantly preserved beta-cell function at 78 weeks compared to placebo. That's the good news. The more sobering part: the drug did not produce statistically significant improvements in the clinical endpoints most of us care about day-to-day, including insulin dose, HbA1c, time in range, or rates of significant hypoglycemia. - the FDA

Preserving C-peptide matters, even residual beta-cell function is associated with smoother glucose management and fewer severe lows over time. But the gap between a lab marker and real-world clinical benefit is worth watching closely as longer-term follow-up data come in. Side effects were mostly manageable: headache, GI symptoms, rash, and transient lymphopenia.

UCSF Scientists Advancing T1D Care from Management Toward Prevention - A detailed look at how UCSF researchers are pursuing regulatory T cells (Tregs) to achieve what they call "antigen-specific tolerance," essentially training the immune system to stop attacking beta cells without broadly suppressing immunity. This is a critical piece of the puzzle for making cell therapies practical for more people. - UC San Francisco

Oral Vaccine Clinical Trials for Type 1 Diabetes - Researchers at the University of Queensland are trialing an oral vaccine designed to "re-educate" the immune system's T-cells, stopping the autoimmune process that destroys beta cells. The work is supported by the Diabetes Australia Research Program and aims to both treat existing T1D and potentially prevent it in at-risk individuals. Still early days, but the oral delivery approach is interesting. - Diabetes Australia

Improved Method to Generate Insulin-Producing Cells from Stem Cell Lines - Researchers at Karolinska Institutet and KTH have developed a protocol that reliably produces more mature, purer insulin-producing cells from multiple human stem cell lines. When transplanted into diabetic mice, these cells gradually restored blood sugar regulation and kept working for several months. The key innovation is optimizing culture steps and encouraging 3D cluster formation, which reduces unwanted cell types and improves glucose responsiveness. - the Swedish Research Council

This is a meaningful step toward making stem cell-derived therapies more consistent and clinically viable. The fact that it works across multiple cell lines is particularly encouraging for eventual patient-specific treatments.

Senseonics' Eversense 365: The First Year-Long CGM Implant - A closer look at how Senseonics' fully implanted CGM works and where it's headed. Unlike transcutaneous sensors that need replacing every couple of weeks, Eversense 365 sits under the skin for up to a year after a single procedure. The company is also positioning it for integration with automated insulin delivery systems like the twiist pump. - Sean Whooley

Glucotrack Study Supports Feasibility of a Three-Year Implantable CGM - Glucotrack published peer-reviewed data in the IEEE Sensors Journal demonstrating long-term stability of its electrochemical glucose sensors over one year, with devices reflecting roughly two years of age. Their system measures glucose directly from blood rather than interstitial fluid, which could eliminate the lag issue. An FDA IDE submission is planned for Q2 2026. - Sean Whooley

Savvy Updates: AI Reliability Warnings and Pivot Pump Clearance - Two things worth flagging from this week's roundup. First, Modular Medical received FDA 510(k) clearance for its tubeless insulin patch pump called Pivot, designed to appeal to people who've been hesitant about traditional pumps. Second, and this is important: studies are showing that AI chatbots give wildly inconsistent carb estimates for the same food image, and many medical responses from these tools are inaccurate yet delivered with high confidence. Please don't rely on AI alone for dosing decisions. - Joanne Milo

That's all for this week. As always, science moves forward one careful step at a time, and we'll be here to keep you informed. Take care of yourselves out there. 💙

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