#23 - 💊 A daily pill that slows T1D

Hey readers! 🎉

This week brings some genuinely exciting developments, from a daily pill that could slow T1D progression to a long-awaited FDA approval that expands your CGM options. We're also diving into what's happening with access to automated insulin delivery and celebrating a Nobel Prize win that has deep roots in T1D research.

Daily Pill Shows Promise in Slowing Type 1 Diabetes – The BANDIT trial shows that baricitinib, an oral medication already used for other autoimmune conditions, can preserve beta cell function and reduce insulin needs when started soon after T1D diagnosis. – European Association for the Study of Diabetes

This is genuinely exciting news. Over 48 weeks, people taking baricitinib maintained better insulin production, had more stable blood glucose, and needed less insulin compared to placebo. The catch? When treatment stopped, those benefits faded, with insulin production declining back to placebo levels. This tells us two important things: the drug works while you're taking it, and we need longer trials to understand if extended treatment can provide lasting benefits.

What makes baricitinib particularly promising is that it's already FDA-approved for other conditions, it's taken as a pill (not an injection), and it's well-tolerated even in young children. About two-thirds of participants responded positively to treatment. The next step is determining whether treating even earlier, perhaps before clinical diagnosis, could prevent or delay T1D onset altogether.

Nobel Prize Awarded to Immunologists Connected to Breakthrough T1D – The 2023 Nobel Prize in Physiology or Medicine went to scientists whose work on immune tolerance is directly relevant to understanding and treating type 1 diabetes. – Joshua Vieth

The prize recognized discoveries about how regulatory T cells (Tregs) help the immune system distinguish between "self" and "non-self," preventing it from attacking the body's own tissues. In T1D, defective Tregs fail to stop the immune system from destroying insulin-producing beta cells. Fred Ramsdell, one of the laureates, is now a scientific advisor to Sonoma Biotherapeutics, which is developing engineered Treg therapies specifically for T1D.

Breakthrough T1D currently funds nearly 40 projects focused on immune tolerance and Treg-based therapies. This Nobel recognition validates decades of research into rebalancing the immune system rather than simply suppressing it, opening pathways to treatments that could provide lasting beta cell protection.

Vertex's quest for a breakthrough in Type 1 diabetes – Vertex is pursuing zimislecel, an off-the-shelf stem cell therapy that helped 10 of 12 trial participants eliminate their need for insulin after a single infusion. – PharmaVoice

In a small Phase 1/2 trial, patients maintained blood sugar targets for a full year after receiving stem cell-derived islet cells infused into the liver. The cells establish insulin production, essentially replacing the function of destroyed beta cells. Currently, recipients need immunosuppressive drugs to prevent rejection, but Vertex is developing a hypoimmune, genetically edited version that would eliminate that requirement.

The company has transitioned to a Phase 1/2/3 study and is working with manufacturing partners Lonza and TreeFrog Therapeutics to scale production. While initially targeting a specific patient population, Vertex's broader vision is to make cell therapy an option for everyone with T1D.

Simplera Sync sensor now FDA approved for use with Minimed 780G – The FDA approved Medtronic's Simplera Sync disposable sensor for use with the MiniMed 780G pump, giving users a choice between Guardian 4 and Simplera Sync. – Diabetes Strong

This approval matters because choice matters. The Simplera Sync offers no-fingerstick calibration, a simple two-step insertion, and five-minute glucose readings. When paired with the 780G's SmartGuard and Meal Detection technologies, it enables continuous prediction and automated correction of glucose levels. Real-world data shows 780G users average 75% time in range with optimal settings.

Medtronic plans a U.S. soft launch later this year. The 780G is also the only automated insulin system with an extended infusion set option lasting up to seven days, reducing injection frequency by 96% compared to daily injection therapies.

Medicaid Opportunities to Improve Access to Automated Insulin Delivery Devices – A new report examines barriers Medicaid beneficiaries face in accessing automated insulin delivery systems, which are now considered standard of care for insulin-requiring diabetes. – Center for Health Care Strategies

The report, supported by the Helmsley Charitable Trust, identifies inconsistent coverage policies across states, burdensome prior authorization requirements, and limited education for providers and patients as key obstacles. This matters because Medicaid members are disproportionately affected by diabetes yet face the most barriers to accessing technology that improves glycemic control, reduces complications, and lowers healthcare costs.

NHS rolls out a world-first initiative providing Hybrid Closed Loop System to Thousands with Type 1 diabetes – England's NHS is implementing a nationwide rollout of hybrid closed loop systems (artificial pancreas technology) following a successful pilot with 835 participants. – The Pharmaceutical and Med Tech Industries

NHS England allocated £2.5 million to identify eligible patients and begin broad access, with NICE approving a five-year implementation plan starting April 1, 2024. Officials caution it may take up to five years to reach everyone due to sourcing, training, and workforce constraints, but this represents the first nationwide rollout of its kind globally.

Managing Cold and Flu with Type 1 Diabetes – Breakthrough T1D provides essential guidance for managing T1D during illness, when stress hormones raise blood glucose and disrupt insulin action. – Breakthrough T1D

The article emphasizes developing a sick-day plan with your healthcare provider before you need it. Key points: monitor glucose and ketones more frequently, stay hydrated to help flush ketones, maintain nutrition even if you don't feel like eating, and be aware that over-the-counter medications can affect blood sugar. Very high ketones can lead to diabetic ketoacidosis (DKA), requiring immediate medical attention.

Prevention remains crucial: get your annual flu shot, prioritize sleep and hydration, and practice good hand hygiene during cold and flu season.

There are currently 67 active Type 1 Diabetes clinical trials recruiting participants across the U.S. and internationally, spanning pharmacologic therapies (including tirzepatide for T1D with obesity), diabetes technology studies (automated insulin delivery, iLet dosing), psychosocial interventions, and pregnancy-related research. California, Texas, Florida, and Colorado host the highest number of trials.

Inhaled Insulin Shows Promise – A study found inhaled insulin demonstrates comparable safety, lung function, and efficacy to injectable insulin in T1D, offering a potential noninvasive alternative. – Pharmacy Times

Non-Invasive Glucose Monitoring – DiaMonTech developed a device using infrared laser technology to measure glucose in 15 seconds without finger-pricking, with plans for desktop, pocket, and wristband versions. – @hpcimedia

CGM Market Growth – The global insulin delivery devices market is projected to grow from USD 35.6 billion in 2024 to USD 53.0 billion by 2032, driven by smart pumps, CGM integration, and mobile connectivity. – DelveInsight

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