Hey readers! This week has an unusually device-heavy lineup: the FDA cleared enhancements for a tubeless patch pump, authorized the first wearable that watches ketones and glucose together, and a familiar mealtime insulin cleared a big trial in China. Here's what actually matters for the people wearing these things every day.
💉 Insulin delivery gets more customizable
Modular Medical Announces FDA Clearance of Pivot Tubeless Insulin Patch Pump Enhancements - The FDA cleared a set of software enhancements for the Pivot tubeless insulin patch pump, adding bolus dosing adjustments, an improved user interface, and other upgrades ahead of a planned fourth-quarter launch. - XPR Newsroom
Modular Medical frames Pivot as an on-ramp: a wearable system delivering both basal and bolus insulin over a three-day wear period, aimed at people moving from multiple daily injections to pump therapy. That positioning matters, because the jump to a pump is where a lot of people stall out, and a simpler tubeless option with more dosing flexibility could lower the barrier.
The cleared improvements represent the first in a series of enhancements and upgrades to the Pivot platform and were designed to expand the functionality and flexibility of Pivot for users, including the ability to customize the amount of insulin delivered with each button push.
The company says this is the first of several planned updates, so treat it as an early build rather than a finished product. Worth watching how the customizable per-push bolus works in real hands once it ships.
🩸 A wearable that finally tracks ketones
FDA Authorizes First Dual Ketone Monitor via De Novo Pathway - The FDA authorized Abbott's Libre Duo 10 Day, described as the first wearable to continuously monitor both ketones and glucose in a single device, for people aged 2 and older. - Quality Smart Solutions
This is a genuinely useful gap-filler for T1D. Until now, ketone checks were single-point-in-time tests that couldn't tell you whether levels were rising or falling. The Libre Duo reads both ketones and glucose in interstitial fluid once every minute over a 10-day wear, sends data to a phone app, and can fire automated alerts when ketones cross a concerning threshold.
The Libre Duo 10 Day is also the first wearable device in the United States to continuously track ketone levels at all.
The authorization was supported by six studies enrolling more than 600 participants, including elevated ketone readings that occurred before the onset of DKA. As the FDA puts it, catching that early can "be the difference between early intervention and a life-threatening emergency." For anyone who has ever squinted at a ketone strip during a sick day, continuous trend data is a meaningful upgrade.
⚡ Ultra-rapid insulin clears a Phase 3 hurdle
Adocia Announces Positive Results from Phase 3 Trial in China - In a 550-patient Phase 3 trial in Chinese adults with Type 1 diabetes, the ultra-rapid insulin BioChaperone Lispro (THDB0206) matched Humalog on HbA1c reduction at 26 weeks and beat it on the post-meal glucose spike. - Ideal Investisseur
The headline finding for mealtime dosing: THDB0206 significantly reduced the postprandial glucose rise versus Humalog, with self-monitored readings confirming better control one hour after eating. That's the whole point of a faster insulin, and it hit its key secondary endpoint. Safety and hypoglycemia rates looked comparable to Humalog.
A caveat on scope: this trial ran in China through Adocia's partner Tonghua Dongbao, which holds authorization responsibilities there. So this is regional progress on a faster mealtime insulin, not yet a broad global filing.
On the basal side, Gan & Lee reported that its once-weekly insulin Ludefen completed the full 52-week SUPER-1 trial in China, showing greater HbA1c reduction than daily insulin glargine U100 (a change from baseline of −1.30% vs −1.00%) in 588 adults with type 2 diabetes, with no severe hypoglycemia in either arm. It's a T2D study, but a stable once-weekly basal is the kind of thing that could eventually reshape dosing routines more broadly.
🧬 On the research bench
A busy stretch for the science that sits behind the devices. A few worth your attention:
Scientists found a 'switch' that can make the pancreas produce insulin again - Harvard researchers used CRISPR screening of more than 19,000 genes to identify ALDH3B2 as a "brake" on pancreatic duct cells; disabling it pushed the share of insulin-like cells from under 1% to 8.5%, and reprogrammed human cells lowered blood sugar in diabetic mice for six weeks. - BB.LV
Converted Human Pancreatic Duct Cells Show Diabetes Therapy Potential - The same ALDH3B2 work, with the important footnote that glucose-stimulated insulin output was still lower than in natural human beta cells. - GEN
Vitamin D supplements lower insulin needs in youth with type 1 diabetes - A meta-analysis of nine trials (370 participants) found vitamin D cut total daily insulin by a mean of 0.13 units/kg/day, though it did not improve HbA1c or preserve beta-cell function. A modest, insulin-sparing signal, not a treatment on its own. - Scienmag
Type 1 Diabetes May Hide Two Distinct Diseases, Large GWAS Suggests - Stratifying by HLA-DR3 vs HLA-DR4, researchers found evidence for two genetically distinct routes to what we call T1D, which could eventually sharpen risk prediction and trial design. - CRBC News
🔬 Toward the root cause
Several groups are still going after the immune attack itself rather than just replacing insulin.
Eledon Pharmaceuticals submitted an IND to the FDA for a registrational islet cell transplantation trial testing tegoprubart to prevent graft rejection in T1D. The company points to earlier results in which all 12 patients achieved insulin independence with an A1c below 7.0% following transplant and treatment.
This enrollment expansion builds on previously reported results in which all 12 patients with T1D achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their disease.
Meanwhile, GentiBio landed a USD 1.07 million NIH grant to advance an off-the-shelf engineered regulatory T cell therapy for newly diagnosed T1D, aiming to fix the cost and persistence problems that dogged earlier Treg approaches. And on the prevention front, teplizumab (an immunotherapy that targets the immune attack on beta cells) is being made available through the NHS in England and Wales to delay onset for those at high risk, with NICE estimating about 1,100 people could benefit in the first year. The catch, as the article notes, is that it depends on identifying immune attack via blood testing before symptoms appear, and routine UK screening is still being built out.
That's the theme tying this issue together: better tools for living with T1D today, and slower, harder work aimed at not needing them tomorrow. Take care of yourselves out there.