#53 - 🧪 Two big NEJM trials + needle-free CGM

Hey readers! 👋 What a week for T1D news. We've got two major clinical trials published in the NEJM, a needle-free CGM that actually works, inhaled insulin for kids, and a sensor that tracks both glucose AND ketones. Grab your coffee (or juice box), and let's dig in. 🧃

Teplizumab and β-Cell Function in Newly Diagnosed Type 1 Diabetes - The PROTECT phase 3 trial results are in, and they tell a nuanced story. Two 12-day courses of teplizumab preserved beta-cell function in newly diagnosed kids and teens (ages 8-17) at week 78, with 94.9% of treated patients maintaining clinically meaningful C-peptide levels versus 79.2% on placebo. That's a real, measurable difference in how much insulin these kids' bodies are still making. – New England Journal of Medicine

Here's the honest takeaway, though: while the primary endpoint was met, teplizumab didn't move the needle on the clinical outcomes most of us care about day-to-day, including insulin dose, HbA1c, time-in-range, or hypoglycemia rates. Preserving beta-cell function matters, but the gap between "your pancreas is still producing some insulin" and "your daily management is meaningfully easier" remains real. This is progress, not a finish line.

Automated Insulin Delivery in Pregnancy with Type 1 Diabetes - The AiDAPT trial from the UK provides strong evidence for hybrid closed-loop therapy during pregnancy. Pregnant women using closed-loop systems spent 68.2% of time in the pregnancy-specific target range (63-140 mg/dL), compared to 55.6% with standard care, a 10.5 percentage-point improvement. Overnight control improved even more, and HbA1c dropped by 0.31%, all without increasing hypoglycemia. – New England Journal of Medicine

For anyone who's navigated T1D pregnancy, you know how relentless the glucose management demands are. This trial adds solid data supporting what many have already experienced: closed-loop systems can meaningfully help during one of the most glucose-sensitive periods of life.

Oral Insulin in Children with Stage 1 Type 1 Diabetes - The Fr1da trial tested whether high-dose oral insulin could slow progression in children with early-stage T1D. After 12 months, it didn't. Progression rates were essentially identical between groups (HR 1.07, P=0.74), and immune responses to insulin were unchanged. The treatment was well-tolerated, but this particular approach doesn't appear to alter the disease trajectory. – Diabetes Care

MIT and Apollon's Needle-Free CGM Matches Leading CGM Accuracy - This is genuinely exciting. Apollon and MIT's laser research center published peer-reviewed results showing their non-invasive CGM, which uses Raman spectroscopy to read glucose through the skin, achieved a MARD of 11.3 and 100% of readings in clinically acceptable zones. No needles, no adhesive patches, no consumables. It's still a shoebox-sized device, not a wearable yet, but the accuracy data is real. A feasibility study at Boston Medical Center is planned for later this year. – Sean Whooley

Abbott Secures CE Mark for Libre Duo: Dual Glucose-Ketone Sensing - Abbott's Libre Duo will continuously measure both glucose and ketones every minute, no separate blood or urine tests needed. For anyone who's worried about DKA, especially parents of young kids, having continuous ketone monitoring on the same sensor could be a meaningful safety layer. CE Mark is approved; European launch is expected later in 2026. – Abbott

Afrezza Inhaled Insulin Approved for Children with T1D - The FDA approved Afrezza for kids ages 6 and up, making it the first and only inhaled mealtime insulin for pediatric T1D. This won't replace basal insulin or work for everyone, but for children who struggle with injection burden, especially at school or in social settings, having an inhaled option adds real flexibility. – Breakthrough T1D

Global Inequalities in Type 1 Diabetes Are Widening - A sobering analysis: T1D incidence among children nearly tripled between 1990 and 2021, and the gap between wealthy and lower-income countries is getting worse, not better. In 2021, countries in the lower half of global income accounted for roughly 80% of T1D deaths and 86% of years of life lost. The disparity comes down to insulin access, monitoring technology, and healthcare infrastructure. These are solvable problems, but they require coordinated global action. – EurekAlert!

That's your week in T1D. Between the pregnancy closed-loop data, needle-free CGM progress, and inhaled insulin for kids, there's a lot moving forward on multiple fronts. See you next week! 💙

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