#56 - 🔬 65 T1D trials at Mayo Clinic alone

Hey readers! 👋

This week we're zooming in on clinical trials - and Mayo Clinic is running a remarkable 65 of them for T1D right now. From hunting for early biomarkers in tiny blood samples to testing closed-loop systems during pregnancy, there's a lot happening in the trial pipeline. We've also got teplizumab updates, a new Phase 2 drug targeting insulin resistance, and some important research on the emotional side of living with this condition. Let's dig in.

Type 1 Diabetes Clinical Trials - Mayo Clinic Research - Mayo Clinic currently lists 65 active clinical studies for T1D, spanning prevention, immune mechanisms, technology, and complications research. – Mayo Clinic Research

The breadth here is worth noting. Studies range from testing "bedside" closed-loop systems that automate overnight insulin delivery to investigating how exercise and emotional stress affect glycemic control on sensor-augmented pumps. There's also work on weekly insulin icodec versus daily glargine, screening feasibility in general clinics, and the effects of glycemic variability on cognition. If you've ever wondered whether research is keeping pace with the complexity of living with T1D, this list is reassuring.

Extracellular Vesicle Cargo During Type 1 Diabetes Progression - This Mayo Clinic study is developing methods to detect the chemokine CXCL10 in beta-cell-derived extracellular vesicles as a potential early biomarker for T1D. – Mayo Clinic

The practical angle here matters: the team is working with small blood volumes, which could eventually make screening more accessible, especially for children. A related Mayo study, Assessment of CXCL10 in Plasma-derived Small Extracellular Vesicles in Children with New Onset Diabetes, is enrolling newly diagnosed kids to validate these same biomarker methods. If CXCL10 pans out, it could help identify T1D earlier in its progression, which connects directly to the next big story.

Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes - The PROTECT Phase 3 trial showed two courses of teplizumab significantly preserved beta-cell function at 78 weeks in children and adolescents with new-onset T1D, though key clinical secondary outcomes like HbA1c and time-in-range did not reach statistical significance. – NEJM

This is a nuanced result. The C-peptide preservation was real and statistically significant, with 94.9% of treated patients maintaining clinically meaningful levels versus 79.2% on placebo. But the lack of clear differences in day-to-day metrics like insulin dose and time-in-range means the clinical impact patients actually feel remains uncertain. Safety was manageable, mostly transient headaches, GI symptoms, and temporary lymphopenia.

'Paradigm-shifting' treatment for pediatric diabetes cleared by FDA - The FDA has now approved teplizumab for children ages 8-17 with recently diagnosed Stage 3 T1D based on these PROTECT results. – FDA/Yale

The approval is significant because it shifts the conversation from purely replacing insulin to preserving the body's remaining ability to produce it. As the NEJM editorial Immune Interventions at Onset of Type 1 Diabetes notes, T1D hasn't seen the same dramatic clinical transformation as many other pediatric diseases over the past half century. Teplizumab is a step, not a destination.

CIR-0602K Begins Dosing in Phase 2 in Type 1 Diabetes - Cirius Therapeutics has started dosing in a Phase 2 trial testing CIR-0602K, a drug targeting mitochondrial metabolism to improve insulin sensitivity in adults with T1D on automated insulin delivery. – Cirius Therapeutics

This one is interesting because it tackles insulin resistance in T1D, something that doesn't get enough attention. Prior T2D data showed roughly 50% reduction in insulin resistance. The trial is small (about 34 participants) with results expected in late 2027, but the approach of improving how the body uses insulin, rather than just delivering more of it, could meaningfully complement existing technology.

SHIELD-T1D Trial Aims to Save Natural Insulin Production - This new trial tests an unusual combination of Shingrix and semaglutide to preserve beta-cell function in the critical window right after T1D diagnosis. – Nataliia Vietchinkina

Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes - The AiDAPT trial found hybrid closed-loop therapy increased time in the pregnancy-specific glucose range by 10.5 percentage points compared to standard intensive care, without unexpected safety concerns. – NEJM

This is meaningful. Pregnancy glucose targets are tighter, and every percentage point of time-in-range matters. Tandem's Control-IQ+ has also received FDA clearance for pregnancy use based on the separate CIRCUIT trial, giving expecting parents with T1D more validated options.

Rural realities: Suicidal ideation and coping in diabetes - A qualitative study found significant emotional distress among people with diabetes in underserved areas, with T1D participants emphasizing lifelong management burden and feeling misunderstood. – PubMed

This research reinforces what many in the community already know: the psychological weight of T1D is real and under-addressed, particularly in communities with limited healthcare access. Social support and spirituality emerged as key coping resources, a reminder that care extends well beyond glucose numbers.

That's your week. With 65 trials running at Mayo Clinic alone and teplizumab now approved for kids, the research pipeline for T1D is active and expanding. The challenge, as always, is translating trial results into real improvements in daily life.

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