Concept: compact dual-hormone patch with stable glucagon

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 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 rose to 80.3%, with median time-below-range of just 1.36%, alongside meaningful gains in quality-of-life and diabetes-distress scores.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 a fresh glucagon fill every day.⁵ Dasiglucagon, an engineered analog with seven amino-acid substitutions, stays soluble and stable in a ready-to-use aqueous solution.⁵⁶ It was FDA-approved in 2021 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 for a decade.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 and its pivotal pediatric trial showed about 10 percentage points more time in range versus standard care.¹¹ A fully closed two-hormone version using a stable glucagon analog is in active clinical development but not yet on the market.⁷

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

What's coming. A large bihormonal pivotal program is underway to test an insulin-plus-dasiglucagon closed loop and support the regulatory filings needed to bring it to market.¹² A separate fully closed bihormonal system already carries a European CE mark and is in real-world use,⁸ with newer, smaller hardware iterations in development. The remaining bar this concept names is the last one: miniaturization — folding that proven two-hormone control into a patch.

References

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. 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. 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. 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. 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 ↩ ↩²

6. Blair HA. Dasiglucagon: first approval. Drugs (2021). https://doi.org/10.1007/s40265-021-01531-z ↩ ↩²

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 ↩ ↩²

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/ ↩ ↩²

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. 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. Messer LH, Buckingham BA, Cogen F, et al. Positive impact of the bionic pancreas on diabetes control in youth 6-17 years old with type 1 diabetes: a multicenter randomized trial. Diabetes Technol Ther (2022). https://doi.org/10.1089/dia.2022.0201.pub ↩

12. BioSpace / Beta Bionics. Beta Bionics announces enrollment into the bihormonal Bionic Pancreas pivotal trial (insulin plus dasiglucagon). Industry release (accessed 2026). https://www.biospace.com/beta-bionics-announces-data-lock-of-the-insulin-only-bionic-pancreas-pivotal-trial-and-enrollment-into-the-screening-protocol-of-the-bihormonal-bionic-pancreas-pivotal-trial ↩