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ObservationalCompletedNCT05669547

Inreda AP fully closed-loop dual-hormone artificial pancreas (DARE trial)

A 243-person, 12-month randomized Dutch trial (DARE, NCT05669547) testing the Inreda AP — a fully automated, dual-hormone (insulin + glucagon) artificial pancreas that runs without meal or exercise announcements — against current best diabetes care. Completed October 2025; primary results not yet published. Prior real-world data on the same device showed time-in-range rising from about 56% to 80% over a year.

Primary endpoints

  • Time in range (glucose 3.9-10.0 mmol/L) at 12 months, measured with an independent blinded FreeStyle Libre Pro IQ sensor

Results so far

No primary results published yet. The DARE trial completed in October 2025, but as of mid-2026 no results are posted on ClinicalTrials.gov and no results paper has appeared in PubMed. For context, an earlier real-world 1-year study of the same Inreda AP device (a separate trial) reported mean time-in-range improving from 55.5% before treatment to 80.3% after one year, with low time spent in hypoglycemia and improved quality-of-life scores.

The full picture

What is being tested, and why it matters

Most automated insulin systems available today are hybrid closed loops: the algorithm handles background insulin, but the person still has to tell it about meals (counting carbohydrates) and often about exercise. The Inreda AP aims to remove that work entirely. It is a fully closed-loop, dual-hormone artificial pancreas that delivers both insulin (to lower glucose) and glucagon (to raise it), runs on its own glucose sensors, and adjusts automatically with no meal or exercise announcements.1 Adding glucagon is meant to let the system push insulin more aggressively while catching the resulting lows, making it one of the most autonomous artificial-pancreas designs tested in people.

The DARE trial (NCT05669547) is the largest and longest test of this device to date. It asks whether such a fully automated system can deliver better long-term glucose control — and a lighter daily burden — than the best care available now.12

Who it is for

Adults aged 18–75 with type 1 diabetes for at least a year, who were already using injections plus glucose monitoring or a hybrid closed loop, but whose control still fell short (time-in-range below 80%, or too much time low).1

How the trial was designed

DARE was a 12-month, open-label, randomized, two-arm trial run across 14 Dutch hospitals, led by UMC Utrecht with the Dutch National Health Care Institute and the device maker, Inreda Diabetic.12 It enrolled 243 participants, randomly assigned 1:1 to either the Inreda AP or to continuing their current care — either a hybrid closed loop or injections plus glucose monitoring.1 The main outcome was time-in-range (glucose 3.9–10.0 mmol/L) at 12 months, measured with an independent blinded sensor so the comparison would be fair.1 The trial also tracked hypoglycemia, HbA1c, quality of life, sleep, and cost-effectiveness.12

Key results

The trial completed in October 2025, but its primary results have not yet been published — no results are posted on the registry, and no results paper has appeared in the medical literature as of mid-2026.1 So the head-to-head answer is still pending.

What we do know comes from an earlier, separate 1-year real-world study of the same Inreda AP device: mean time-in-range improved from 55.5% before treatment to 80.3% after a year, time spent low stayed low (median 1.4%), and quality-of-life and diabetes-distress scores improved.3 An earlier 2-week crossover study likewise found the dual-hormone system reached ~87% time-in-range versus ~54% on pump therapy, without meal or exercise announcements.4

What it means and what is next

If DARE confirms these gains in a large randomized comparison, it would be strong evidence that a fully hands-off, dual-hormone system can match or beat today's hybrid loops while removing carb counting. The publication of DARE's 12-month results — including the cost-effectiveness analysis that informs Dutch reimbursement — is the next milestone to watch.12

References

  1. UMC Utrecht. Dual Hormone Closed Loop in Type 1 Diabetes: a Randomized Trial (DARE). ClinicalTrials.gov (NCT05669547; status verified Jan 2026). https://clinicaltrials.gov/study/NCT05669547 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9

  2. Jancev M, Snoek FJ, Frederix GWJ, et al. Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands — study protocol. BMJ Open (2023). https://doi.org/10.1136/bmjopen-2023-074984 ↩ ↩2 ↩3 ↩4

  3. 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 Digital Health (2024). https://doi.org/10.1016/S2589-7500%2824%2900002-5 ↩

  4. 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 ↩