Inreda AP fully closed-loop dual-hormone artificial pancreas (DARE trial)
What this study tests
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.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2026-01-21.
Source dates appear in the references where available; this record has no dated citation metadata.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults with type 1 diabetes for at least 1 year, HbA1c at or below 91 mmol/mol, already using either multiple daily injections plus flash/continuous glucose monitoring or a hybrid closed-loop system for at least 3 months, with imperfect control (time-in-range under 80% or time-below-range over 4%), and willing to use Humalog insulin. Key exclusions: BMI over 35, kidney impairment (eGFR under 30), daily acetaminophen use, active retinopathy, pregnancy, or use of oral glucose-lowering drugs. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- 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.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
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
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, reflecting a design intended to operate with high autonomy.
The DARE trial (NCT05669547) is a large 12-month randomized test of this device. 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 suggest that a fully hands-off, dual-hormone system can improve glucose control 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
Sources
- [1]NCT05669547: study record · Trial registry — Current status, study design and eligibility checked 16 September 2026; this does not imply posted outcomes.
UMC Utrecht. Dual Hormone Closed Loop in Type 1 Diabetes: a Randomized Trial (DARE). ClinicalTrials.gov (NCT05669547; status verified Jan 2026).
- [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
- [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