#27 - 🌟 Tzield fast-tracked for stage 3 T1D

Hey readers! 🌟

This week brings a wave of new developments, from disease-modifying therapies gaining momentum to innovative research on everything from stomach cells to air pollution. We're seeing real progress in both preventing T1D and making daily management easier, plus some fascinating insights into how our bodies (and even our environment) interact with diabetes. Let's dive in!

Tzield (teplizumab) has been fast-tracked by the FDA for potential use in stage 3 type 1 diabetes under the Commissioner's National Priority Voucher program, which could slash review times from nearly a year to just 1-2 months. Already approved to delay progression from stage 2 T1D, Tzield showed in the PROTECT trial that it can preserve beta-cell function in newly diagnosed children and teens aged 8-17 by slowing C-peptide decline. If approved for stage 3, this would dramatically expand the eligible population and shift diabetes care toward earlier immune intervention, potentially reducing long-term complications. The move signals growing recognition that T1D treatment shouldn't wait until most beta cells are gone.

– T1D Strong

Two new phase 3 trials are launching to investigate baricitinib, a JAK inhibitor, in delaying T1D onset and preserving beta-cell function. The BARICADE-DELAY trial will enroll high-risk individuals to see if baricitinib can prevent progression to clinical stage 3 T1D, while BARICADE-PRESERVE will focus on newly diagnosed patients. These trials build on the promising BANDIT study, which demonstrated baricitinib's safety and effectiveness in preserving insulin production during the critical "honeymoon period." Breakthrough T1D has been a strong advocate for JAK inhibitors, recognizing their potential to fundamentally change how we approach T1D treatment by targeting the autoimmune attack itself rather than just managing its consequences.

– Breakthrough T1D

A kidney drug trial offers new hope for people with T1D and chronic kidney disease. The Phase 3 FINE-ONE trial showed that finerenone (Kerendia) reduced albuminuria by approximately 25% in 242 participants after six months, suggesting it could slow progression to kidney failure. This matters because 30-40% of people with T1D develop chronic kidney disease, yet treatment options have remained essentially unchanged for over three decades, typically limited to ACE inhibitors or ARBs. Kerendia is already used for kidney disease in type 2 diabetes, and these results could finally bring a new therapeutic option to the T1D community.

– UPI

Researchers have successfully reprogrammed human stomach organoids to secrete insulin, offering a potential new avenue for autologous cell therapy. By differentiating human embryonic stem cells into gastric organoids and then reprogramming them into pancreatic beta-like cells, the team transplanted these engineered organoids into diabetic mice, which maintained normal blood glucose levels for up to six weeks. While the treatment didn't provide long-term management, this proof-of-principle study demonstrates the feasibility of reprogramming a person's own stomach tissue to generate insulin-secreting cells, potentially avoiding immune rejection issues that plague other cell-based therapies.

– Sneha Khedkar

The top CGM stories of 2025 highlight rapid innovation in glucose monitoring. Glucotrack is developing a unique three-year continuous blood glucose monitor with no external on-body component, measuring glucose directly from the blood. Senseonics partnered with Sequel Med Tech to integrate its year-long Eversense 365 CGM with an automated insulin delivery system, marking the first such compatibility. Biolinq received FDA clearance for its needle-free Shine biosensor that provides real-time monitoring without subcutaneous needles. Meanwhile, Medtronic unveiled the Instinct sensor, built on Abbott's FreeStyle Libre platform and designed specifically for integration with its MiniMed 780G pump, demonstrating the power of industry partnerships.

– Sean Whooley

Hybrid closed-loop systems show promise in very young children but also reveal important challenges. A study of 72 children under six found that HCL improved time in range by 11% and reduced time above range by 13% within the first month, with benefits sustained over 12 months. The greatest improvements occurred overnight, but researchers identified a high-risk period for hypoglycemia in the late morning. This finding emphasizes the importance of optimizing HCL therapy settings and educating parents about specific times of day that carry higher risk of glycemic instability, particularly as insulin needs can change rapidly in young children.

– PubMed

Advanced hybrid closed-loop systems may protect against heatwaves, according to a study of 193 adults with T1D during Spain's August 2023 heatwaves. Glycemic control remained stable throughout the extreme heat period, with no significant changes in time in range, insulin dose, or time in automation. This suggests that AHCL systems' ability to automatically adjust insulin delivery may help buffer against environmental stressors that would otherwise disrupt glucose management, offering reassurance as climate change brings more frequent extreme weather events.

– PubMed

CGM use significantly improved glycemic control in Korean children and adolescents with T1D over 12 months. The CGM group saw HbA1c decline from 8.68% to 7.92%, while the self-monitoring group's HbA1c rose from 8.46% to 8.93%, a significant between-group difference. Interestingly, other metrics like time in range and hypoglycemia didn't show significant changes, and CGM activation time declined slightly, suggesting that even imperfect CGM use can drive meaningful improvements in overall glycemic control.

– PubMed

The timing of nocturnal hypoglycemia matters for sleep quality. A study of 27 adults with T1D found that hypoglycemia occurring during late sleep (3:00-6:00 AM) significantly reduced the odds of reporting better sleep quality, while early-night hypoglycemia (midnight-3:00 AM) showed no association. This finding suggests that our bodies may be more sensitive to glucose fluctuations during certain sleep stages, and that preventing late-night lows could be particularly important for overall well-being and daytime function.

– Suresh Rama Chandran et al.

Sleep patterns vary significantly in people with T1D and correlate with glucose control. Children with higher sleep variability had higher glucose levels, while those with suboptimal glucose control had shorter sleep duration. Adults with T1D reported poor sleep quality and insufficient sleep hours, both correlating with higher glycemic variability. Interestingly, first-generation automated insulin delivery systems didn't improve sleep patterns, though coaching and counseling showed promise, suggesting that technology alone may not address all sleep-related challenges.

– PubMed

Air pollution poses a significant risk for people with T1D. A study of 12,925 individuals in Utah found that increased one-year exposure to PM2.5 particulate matter raised the risk of diabetic ketoacidosis by 28.8%, ophthalmic complications by 33.5%, and neurological complications by 35.1%. The researchers hypothesize that PM2.5-induced oxidative stress and systemic inflammation exacerbate metabolic disruptions in hyperglycemic individuals, suggesting that environmental factors like air quality should be considered in T1D management and that clean air policies have direct health implications for our community.

– PubMed

HLA genetic markers differ significantly between Chinese and Caucasian populations with T1D. The study identified four haplotypes involving the DRB1*09:01 allele that are unique to East Asian populations and associated with T1D susceptibility but not in Caucasians. Patients with certain susceptible haplotypes showed distinct islet autoantibody positivity rates, indicating different immunological profiles. These findings underscore the importance of considering population-specific genetic markers in disease study and management, as risk factors and disease mechanisms may vary across ethnic groups.

– PubMed

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