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Concept: compact dual-hormone patch with stable glucagon

What it is

What we should build: a small, patch-sized dual-hormone system using a pump-stable glucagon analog, so a fully closed loop with an active brake against lows fits the same daily footprint as a single-hormone patch. The engineering bar real products should aim at is stable glucagon plus miniaturization.

Editorial review: .

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What we should buildconceptualdual-hormoneglucagonfully-closed-loopconceptstable-glucagonminiaturization

Evidence behind this assessment

Key evidence notes. Study results, product eligibility and access answer different questions.

Who was studied?
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Benefit or performance
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Important harms and treatment burden
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Approval and country access
Country-specific approval and access are not summarized in this record.Approval, trial recruitment, local supply and funding are separate. Check the cited label or access source.
Follow-up and remaining uncertainty
Read the full discussion and original sources for follow-up duration and study limitations.

Research status alone does not establish approval, clinical benefit or local availability.

Unranked design concept

This entry describes desired features and related research. It has no product-performance score or ranking. Named products and research programmes have their own evidence records.

The full picture

This is an advocacy target, not a product you can buy. It names the engineering bar a real device should clear: put a fully closed, two-hormone loop into roughly the footprint of a single-hormone patch.

Which hormones, and how the second one defends lows. The system delivers insulin to bring glucose down and glucagon — the hormone a healthy pancreas releases to raise glucose — to push it back up. That glucagon channel is what gives an automated loop an active brake against lows, rather than only the passive option of cutting insulin and waiting. In randomized trials, a bihormonal "bionic pancreas" delivering both insulin and glucagon reportedly lowered average glucose and cut time spent low versus insulin-pump therapy, with no carbohydrate counting required.12 (Amylin is a separate second-hormone path aimed mainly at smoothing post-meal spikes, not at defending lows — this concept is about the glucagon brake.)

Trial outcomes. A fully closed two-hormone loop reached a median 86.6% time in range over two weeks with no meal or exercise announcements at all.3 A one-year real-world study of a fully closed bihormonal system found mean time in range of 80.3%, with median time-below-range of just 1.36%, alongside gains in quality-of-life and diabetes-distress questionnaire scores reported in the study.4

The glucagon-stability problem. The reason this isn't already standard is chemistry: native human glucagon is unstable in water and tends to clump and form fibrils, so older bihormonal systems needed fresh glucagon fills.5 Dasiglucagon, an engineered analog, stays soluble and stable in a ready-to-use aqueous solution.56 It was FDA-approved for severe-hypoglycemia rescue,6 and a feasibility study has already run it through a dual-hormone pump — clearing the formulation hurdle that stalled the field.7

Device burden of two hormones. Two hormones means two reservoirs, two infusion sets, and two glucose sensors. Today's fully closed bihormonal system is worn as a separate body-mounted unit, with the maker offering a hip bag, belt bag, and special shirt to carry it8 — far from a discreet patch. That gap is the concept: the build worth funding is the one that makes the second hormone disappear into the daily footprint people already accept.

Maturity and approvals. No patch-sized bihormonal device is approved anywhere. The closest shipping reference points are insulin-only: the iLet Bionic Pancreas was FDA-cleared in 2023 as an insulin-only system that initializes on body weight and needs no carb counting.910 A fully closed two-hormone version using a stable glucagon is in active clinical development — Beta Bionics entered a Phase 2a feasibility trial of a bihormonal iLet in Q1 2026 — but nothing is on the market.711

Access. Speculative. A second hormone adds consumable cost and a second supply chain, and pricing for a future device is unknown.

What's coming. The dasiglucagon pivotal that was once planned reportedly never ran. Back on 6 May 2024 Beta Bionics signed an exclusive worldwide collaboration and license agreement with Xeris Biopharma for a pump-stable glucagon formulation,12 and the Zealand–Beta Bionics dasiglucagon partnership was reported terminated in October 2024.13 Those are settled history, not recent news; what is recent is the clinic. The live programme pairs the iLet with that Xeris glucagon, and Beta Bionics reported in April 2026 that it had started a Phase 2a feasibility trial of the bihormonal system in New Zealand in the first quarter of 2026.11 That is a feasibility study, not a registration trial — no filing follows directly from it. A separate fully closed bihormonal system already carries a European CE mark and is in real-world use,8 with newer, smaller hardware iterations reported in development. The remaining bar this concept names is the last one: miniaturization — folding that proven two-hormone control into a patch.

Coming soon

ETA · Concept / advocacy target — no patch-sized bihormonal device approved anywhere; aspirational

  • →Beta Bionics began a Phase 2a bihormonal feasibility trial in New Zealand in Q1 2026, using a pump-stable Xeris glucagon — a feasibility study, not a registration trial · Q1 2026
  • →A separate fully closed bihormonal system (CE-marked, in EU real-world use) has newer, smaller hardware iterations reported in development

Sources

  1. [1]

    Russell SJ, El-Khatib FH, Sinha M, et al. Outpatient glycemic control with a bionic pancreas in type 1 diabetes. N Engl J Med (2014). https://doi.org/10.1056/NEJMoa1314474

  2. [2]

    El-Khatib FH, Balliro C, Hillard MA, et al. Home use of a bihormonal bionic pancreas versus insulin pump therapy in adults with type 1 diabetes: a multicentre randomised crossover trial. Lancet (2016). https://doi.org/10.1016/S0140-6736%2816%2932567-3

  3. [3]

    Blauw H, Onvlee AJ, Klaassen M, van Bon AC, DeVries JH. Fully closed loop glucose control with a bihormonal artificial pancreas in adults with type 1 diabetes: an outpatient, randomized, crossover trial. Diabetes Care (2021). https://doi.org/10.2337/dc20-2106

  4. [4]

    van Bon AC, Blauw H, Jansen TJP, et al. Bihormonal fully closed-loop system for the treatment of type 1 diabetes: a real-world multicentre, prospective, single-arm trial in the Netherlands. Lancet Digit Health (2024). https://doi.org/10.1016/S2589-7500%2824%2900002-5

  5. [5]

    Xu B, Tang G, Chen Z. Dasiglucagon: an effective medicine for severe hypoglycemia. Eur J Clin Pharmacol (2021). https://doi.org/10.1007/s00228-021-03183-0

  6. [6]

    Blair HA. Dasiglucagon: first approval. Drugs (2021). https://doi.org/10.1007/s40265-021-01531-z

  7. [7]

    Castellanos LE, Balliro CA, Sherwood JS, et al. Performance of the insulin-only iLet bionic pancreas and the bihormonal iLet using dasiglucagon in adults with type 1 diabetes in a home-use setting. Diabetes Care (2021). https://doi.org/10.2337/dc20-1086

  8. [8]

    Inreda Diabetic. Discover the AP — a bihormonal fully closed-loop system delivering insulin and glucagon. Manufacturer site (accessed 2026). https://www.inredadiabetic.nl/en/discover-the-ap/

  9. [9]

    U.S. Food and Drug Administration. FDA clears new insulin pump and algorithm-based software to support enhanced automatic insulin delivery. FDA News (2023). https://www.fda.gov/news-events/press-announcements/fda-clears-new-insulin-pump-and-algorithm-based-software-support-enhanced-automatic-insulin-delivery

  10. [10]

    Beta Bionics. Beta Bionics announces FDA clearance and commercialization of the iLet Bionic Pancreas. Press release (2023). https://investors.betabionics.com/news-releases/news-release-details/beta-bionics-announces-fda-clearance-and-commercialization-ilet

  11. [11]

    Beta Bionics. Beta Bionics Announces First Quarter 2026 Financial Results and Raises Full Year 2026 Guidance (initiated a Phase 2a bihormonal feasibility trial in New Zealand in Q1 2026). GlobeNewswire (21 April 2026). https://www.globenewswire.com/news-release/2026/04/21/3278400/0/en/Beta-Bionics-Announces-First-Quarter-2026-Financial-Results-and-Raises-Full-Year-2026-Guidance.html

  12. [12]

    Xeris Biopharma. Xeris Enters Into an Exclusive Worldwide Collaboration and License Agreement with Beta Bionics (pump-stable glucagon for the bihormonal iLet). Xeris Biopharma press release (6 May 2024). https://xerispharma.com/news-releases/news-release-details/xeris-enters-exclusive-worldwide-collaboration-and-license

  13. [13]

    Fierce Pharma. Zealand's hypoglycemia drug suffers another FDA rejection tied to CDMO inspection (noting the October 2024 termination of the Zealand–Beta Bionics dasiglucagon partnership). Fierce Pharma (2024). https://www.fiercepharma.com/pharma/zealand-suffers-2nd-fda-rejection-hypoglycemia-drug-tied-cdmo-inspection