Hey readers! 👋
What a week. Teplizumab is making headlines on both sides of the Atlantic, GLP-1s are quietly building a case for a bigger role in T1D, and there's a new CGM promising a full month of wear. Oh, and Omnipod just dropped some juicy details about what's coming in 2027. Let's dig in.
💊 Teplizumab: A Big Week for Tzield
This was easily the biggest story of the week, so let's unpack it properly. Teplizumab (brand name Tzield) received two major regulatory milestones in quick succession, one in the US and one in the UK, each for a different stage of T1D.
FDA Approves Teplizumab-mzwv for Children With Newly Diagnosed Stage 3 Type 1 Diabetes - The FDA granted accelerated approval for Tzield in children ages 8-17 recently diagnosed with stage 3 T1D, making it the first therapy aimed at slowing beta-cell loss after diagnosis. – Pharmacy Times
Why Sanofi's Tzield Expansion Changes the Treatment Window - This thoughtful analysis explains what the expanded approval actually means in practice. The shift from presymptomatic screening (stage 2) into routine post-diagnosis care is significant because it makes eligible patients easier to identify, but it also introduces real logistical challenges. Two 12-day IV infusion courses are no small ask, and the PROTECT trial's eligibility window was just six weeks post-diagnosis. – PharmaDeviceNews
"The clinical value will depend on whether preserving more endogenous insulin reduces insulin requirements, improves glucose stability, lowers hypoglycemia risk or delays complications over a meaningful period."
That quote captures the honest tension here. The PROTECT trial data published in NEJM showed teplizumab significantly preserved C-peptide (a marker of beta-cell function) at 78 weeks, but key secondary clinical endpoints like insulin dose, HbA1c, and time in range did not reach statistical significance. The confirmatory BETA-PRESERVE trial will be critical. – NEJM
Meanwhile, across the pond: NHS Approves Teplizumab for Stage 2 T1D - NICE approved Tzield for children aged 8+ and adults with early-stage (pre-symptomatic) T1D, where it can delay onset of symptomatic disease by an average of nearly three years. About 1,100 people are expected to be eligible in the first year, with UK screening programs like Elsa and T1DRA helping identify candidates. – The Independent
Diabetes UK called it a "landmark moment." For families navigating a stage 2 diagnosis, the idea of buying nearly three additional years before insulin dependence is genuinely meaningful.
💉 GLP-1s and Type 1: Building the Evidence
First Expert Consensus Guidelines for GLP-1 Use in T1D - With off-label GLP-1 use in T1D outpacing formal evidence, an expert consensus statement now provides practical safety guidance. The core message: never stop insulin, use CGM, monitor ketones, start low and go slow. – Beyond Type 1
"People with type 1 diabetes are already using these therapies, but without safe use guidelines," said Dr. Garg.
This is exactly the kind of interim guidance the community needs while we wait for formal trials.
GLP-1 RAs Show No Increased Risk of DKA or Pancreatitis in T1D - Real-world data from AACE 2026 analyzed over 7,000 adults with T1D and found zero DKA or pancreatitis admissions among 255 GLP-1 RA users over one year. Small cohort, single center, but reassuring. – Justin Do
GLP-1 Drugs May Cut Heart and Kidney Risks in T1D - A Nature Medicine observational study of 174,000+ people with T1D found GLP-1 RA use was associated with a 15% reduction in cardiovascular risk and 19% reduction in kidney disease risk. Observational data can't prove causation, but these numbers are worth watching closely. – ProEventMed
⚙️ Tech Updates
FiberSense CGM Receives CE Mark for European Market - A new CGM using optical sensing technology just earned European approval, and its standout feature is a 28-day sensor wear time, roughly double what most current sensors offer. More competition in the CGM space is always welcome. – MassDevice
Omnipod COO Talks Omnipod 5 Updates and Omnipod 6 at ADA - Insulet's Eric Benjamin shared that Omnipod 5 now supports a 100 mg/dL lowest glucose target, a new algorithm update keeps users in automated mode longer, and FreeStyle Libre 3+ compatibility is here. Looking ahead, Omnipod 6 (expected 2027) will feature a new algorithm, improved wearability, and updatable pods. Perhaps most interesting: Insulet is developing a fully closed-loop system for type 2 diabetes that requires zero user inputs. – Scott Benner, Juicebox Podcast
"It's as easy for them to write as CGM. Customers pick it up from a local pharmacy, bring it home, and they can start it without any required inputs."
🧬 Research Worth Watching
New Machine-Learning Genetic Risk Score Improves T1D Prediction - UC San Diego researchers developed T1GRS, which identifies four genetic sub-types of T1D with distinct clinical profiles and achieved 87% accuracy in external validation. This could help identify high-risk individuals earlier, especially those missed by traditional screening. – UC San Diego
Mitraa-T1D: AI Conversational Tool Reduces Diabetes Distress - A 12-week randomized trial of 180 adults showed this generative AI tool significantly lowered diabetes distress and improved self-care behaviors versus standard care, with built-in safety guardrails for emergencies. – Archynewsy
📋 Quick Hits
New-Onset T1D Clinical Trials Directory - If you or someone you know was recently diagnosed, T1DTrials.org maintains an updated list of immunotherapy trials with eligibility details and locations. – T1DTrials.org
UF Diabetes Institute News Hub - A solid resource for following ongoing T1D research at one of the leading diabetes research centers. – UF Health
That's a wrap for this week. Between teplizumab's dual approvals, emerging GLP-1 safety data, and new tech on the horizon, there's a lot to process. As always, talk to your care team before making any changes based on what you read here.
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