- βStable glucagon analogs like dasiglucagon have solved the key formulation barrier that blocked dual-hormone wearables for decades
- βBeta Bionics' bihormonal iLet showed meaningful hypoglycemia reduction over insulin-only closed-loop systems in early clinical studies
- βMultiple active trials in Europe and the US are generating the real-world evidence needed for regulatory approval within the next 2-4 years
The Problem with Insulin-Only Systems
Every closed-loop insulin pump on the market today β from Medtronic's MiniMed 780G to Tandem's Control-IQ β does something remarkable: it automatically adjusts insulin based on continuous glucose readings. But these systems share a fundamental limitation. They only use one hormone.
Your healthy pancreas uses two. When blood sugar drops, the pancreas releases glucagon, a hormone that signals the liver to release stored glucose. This push-pull system between insulin and glucagon is what keeps blood sugar remarkably stable in people without diabetes. Current devices have only half of that equation.
The result? Modern automated insulin delivery (AID) systems are excellent at preventing highs but still struggle with hypoglycemia β dangerous low blood sugar episodes that affect roughly 30% of people with Type 1 diabetes regularly. A dual-hormone approach could change that fundamentally.
What a Dual-Hormone Patch Actually Is
Rather than a traditional pump worn on a belt with tubing, next-generation dual-hormone devices aim to be fully wearable patch systems β adhesive, tubeless devices worn directly on the skin, similar in concept to existing patch pumps like Insulet's Omnipod.
The engineering challenge is significant. Insulin and glucagon cannot simply be mixed together in one reservoir β they chemically destabilize each other. Early dual-hormone research used two separate reservoirs and delivery mechanisms in a single wearable housing, which added bulk and complexity.
The bigger obstacle has historically been glucagon itself. Natural glucagon is unstable in liquid form and degrades within hours. This made any wearable glucagon delivery impractical β until recently.
Stable Glucagon: The Breakthrough That Changed Everything
The field shifted dramatically with the development of stable glucagon analogs β chemically modified versions of glucagon that remain active in liquid form for days rather than hours.
Two compounds moved this research forward meaningfully:
- Dasiglucagon (Zealand Pharma): A glucagon analog stable in aqueous solution. Zealand's HypoPal rescue pen received FDA approval in 2021, and the company has been developing dasiglucagon specifically for use in dual-hormone closed-loop systems.
- Mini-glucagon and soluble glucagon formulations: Academic groups including researchers at the Oregon Health & Science University (OHSU) have worked with soluble glucagon in bihormonal systems.
With stable glucagon available, device engineers could finally design practical wearable systems that deliver both hormones over multi-day wear periods.
Key Research and Trials Underway
The most advanced bihormonal closed-loop research has come from several fronts:
Beta Bionics and the iLet Bionic Pancreas reached a major milestone with the PROTECT trial β a pivotal clinical trial evaluating the iLet system in adults and children with Type 1 diabetes. The iLet received FDA approval in June 2023 as an insulin-only system (using Humalog or Novolog), but Beta Bionics has continued development of a bihormonal version using dasiglucagon, with clinical studies ongoing as of 2025. Early trials showed the bihormonal iLet reduced hypoglycemia more effectively than the insulin-only version.
Inreda Diabetic, a Dutch medical device company, has been running European clinical studies of their dual-hormone AP system, which uses both insulin and glucagon. Their system showed significant reductions in hypoglycemia time in trials published in peer-reviewed literature.
Academic research consortia, including groups funded through JDRF (now Breakthrough T1D) and NIH, continue to refine control algorithms that decide exactly when and how much glucagon to deliver β a surprisingly complex decision-making challenge.
Current Status
As of 2025, no dual-hormone patch system has received FDA approval for commercial use in the United States. The iLet insulin-only system is FDA-approved; its bihormonal version remains in clinical development. European studies are more advanced, with several bihormonal systems having completed or actively running trials.
The primary remaining hurdles are regulatory approval, miniaturization of dual-reservoir patch hardware, and long-term data on stable glucagon analog safety with continuous micro-dosing. Most analysts expect the first commercially available dual-hormone closed-loop device to reach patients between 2026 and 2029.
What This Means for Patients
If you currently live with Type 1 diabetes, dual-hormone systems represent the most significant potential improvement in automated insulin delivery since closed-loop systems launched. The specific benefits under investigation include:
- Fewer hypoglycemic episodes β glucagon micro-doses can prevent lows before they happen, not just suspend insulin
- Reduced hypoglycemia fear β a major quality-of-life burden for many patients
- Better overnight control β nighttime lows are where bihormonal systems show the most dramatic improvement in trials
- More dietary flexibility β the system can correct more aggressively after meals knowing it has a safety net
The technology is real, the trials are happening now, and the timelines β while not immediate β are realistic. For patients currently using AID systems, monitoring Beta Bionics' bihormonal development and European regulatory progress is worthwhile. The closed-loop system of the future delivers both sides of your body's original design.