#41 - 🫀 An implantable pump inches closer

Hey readers! 👋 Welcome back to another packed week in the T1D world. This week we've got implantable pumps inching closer to reality, a meal-free AID system getting FDA clearance, fascinating mouse studies that have us cautiously optimistic, and a major teplizumab trial that delivered some mixed but important results. Grab your coffee (bolus accordingly) and let's dig in.

FDA grants breakthrough device designation for implantable insulin pump - Portal Diabetes's implantable Portal Pump, which delivers insulin directly into the peritoneal space using a proprietary temperature-stable insulin formulation, has received FDA breakthrough device designation. – Healio

This is one of the most intriguing developments we've seen in a while. Intraperitoneal insulin delivery more closely mimics how the body naturally processes insulin through the liver, which could mean tighter control with less effort. Two patients in San Diego have already received Portal Insulin injections, and full clinical trials are planned for late 2027. The surgical implantation aspect will raise eyebrows for some, but the potential reduction in daily management burden is significant.

Diabeloop's DBLG2 clears FDA without requiring meal announcements - The DBLG2 has become the first automated insulin delivery system cleared by the FDA that doesn't require users to announce meals, a meaningful step toward truly autonomous insulin delivery. – Joanne Milo, The Savvy Diabetic

For anyone who's ever forgotten a meal bolus (so, all of us), this is genuinely exciting. The same roundup notes that Medtronic has expanded the MiniMed 780G's FDA label to include ultra-rapid insulins Fiasp and Lyumjev, which also opens the door to Medicare coverage for more users. Two wins in one week for pump users.

Sequel and Senseonics announce full U.S. launch of twiist AID paired with Eversense 365 CGM - The twiist system becomes the first automated insulin delivery platform compatible with a year-long implantable CGM, and it also supports the Abbott FreeStyle Libre 3 Plus sensor. – Drug Delivery Business

One sensor for an entire year, paired with an automated pump. The twiist system uses the Tidepool Loop algorithm and sound-wave technology for precise dosing. For people tired of swapping sensors every week or two, this combination could meaningfully reduce device fatigue. Choice in CGM pairing is a welcome addition too.

Teplizumab and beta-cell function in newly diagnosed Type 1 diabetes - In a phase 3 trial of 328 newly diagnosed children and adolescents, teplizumab preserved beta-cell function (measured by C-peptide) at 78 weeks, but did not translate into differences in insulin dose, A1C, or time in range compared to placebo. – New England Journal of Medicine

This is one of those results that requires nuance. Preserving C-peptide production is biochemically meaningful, as it suggests the immune attack on beta cells is being slowed. But the lack of clinical differences in day-to-day outcomes like insulin needs and glucose control is a reality check. It doesn't mean teplizumab is without value; it may mean we need longer follow-up or combination approaches to see tangible benefits for patients.

Stanford scientists reverse T1D in mice without insulin or immune suppression - A dual transplant of mismatched blood stem cells and pancreatic islets created a hybrid immune system that both accepted the new islets and halted the autoimmune attack, all without immunosuppressive drugs. – SciTechDaily

The conditioning regimen uses clinically approved drugs and low-dose radiation, which makes a human translation pathway more plausible than many preclinical studies. Still early days, but the dual approach of replacing islets while resetting immunity tackles both sides of the T1D equation.

Cornell's nanofiber device keeps insulin-producing cells alive for 200 days in mice - The NICE device protects transplanted insulin-secreting cells from immune attack while allowing nutrients through, maintaining normal blood glucose for roughly six months without immunosuppression. – Cornell Chronicle

Join a trial testing automated insulin delivery for cystic fibrosis-related diabetes - A 150-person crossover trial is recruiting teens and adults with CFRD to evaluate the iLet Bionic Pancreas, which could lighten the management load for a population already dealing with enormous health complexity. – Diatribe

TrialNet's 2025 year in review - TrialNet completed enrollment for two immune-therapy trials (T1D RELAY and JAKPOT T1D), screened over 10,000 individuals for early-stage T1D, and is gearing up for the RESET T1D Study testing rezpegaldesleukin. – TrialNet

The screening numbers alone are impressive. Early detection remains one of the most powerful tools we have, and TrialNet's expanding network of clinical centers means more families can access screening. If you have relatives with T1D who haven't been screened, this is worth flagging.

That's a wrap for this week. The pace of innovation across devices, immunology, and cell therapy continues to accelerate, and we'll keep sorting through it all so you don't have to. Until next time, take care of yourselves. 💙

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