Inreda Diabetic and the EIC Accelerator: A Pump Not Yet for Sale

Hybrid closed-loop insulin pumps still leave people with type 1 diabetes managing insulin for meals and exercise, a task the authors of a 2024 trial in The Lancet Digital Health say can be burdensome. Inreda Diabetic, a company in Goor in the Dutch region of Twente, built a device meant to take that task away: two sensors read glucose, and the device doses insulin when the level climbs and glucagon when it drops, with no carbohydrate counting at all. The company calls it a bi-hormonal fully closed loop, and a 2023 trial protocol describes the same set-up: two pumps, an algorithm, two sensors and two infusion sets.

The EIC Accelerator selected Inreda's DIABEACON project at the 1 October 2025 cut-off, where the EIC's list of selected companies names it among the blended finance awards. CORDIS records a signed grant agreement with an EU contribution of €2,499,414.12, running from 1 July 2026 to 30 June 2028. Inreda Diabetic now holds a €2.5M EIC Accelerator grant for a device that has carried a CE mark since 2020 and that, by the company's own account, nobody can yet buy.

A pump with a second hormone

Insulin lowers blood glucose and glucagon raises it. Inreda carries both in one device, and the company says it uses insulin and glucagon to prevent or treat high and low glucose respectively. The company's FAQ says the device uses two Guardian sensors, one for dosing and one to check the first, and measures 11.9 by 7.7 by 3.7 centimetres. It is worn on the front of the body, day and night, and is not waterproof.

The DARE trial protocol adds two practical details: wearers replace the glucagon in the pump every day, and the device had only been tested with one insulin, Humalog. The company describes its algorithm as self-learning, adjusting insulin settings to each user, and says that meal and exercise announcements are not required.

The work goes back further than the EIC award. In the EU's FP7 programme, CORDIS records Inreda as a partner in PCDIAB, a portable bihormonal closed loop project coordinated by the Academic Medical Center in Amsterdam from September 2012 to May 2016, with €908,400 of EU funding allocated to Inreda (North Data lists €896,711). From 2018 the European Regional Development Fund put €782,545 into a microneedle version of the pump with U-Needle and the University of Twente, according to the European Commission.

What the trial data show

The main published evidence is a one-year, single-arm trial in The Lancet Digital Health from March 2024, run in eight Dutch outpatient clinics. According to the abstract, 82 adults were enrolled, 79 started treatment and 71 were included in the 12-month analysis. Their mean time in the target glucose range was 55.5% before the trial and 80.3% after a year, and median time below range was 1.36%. Five serious adverse events were reported: one cerebellar stroke, two severe hypoglycaemic events and two hyperglycaemic events.

Two points matter when reading those numbers. The trial had no control group, and the 80.3% figure covers the people who completed the year, not everyone who started. The paper was also funded by Inreda Diabetic, and its declaration of interests lists four of the authors as company employees. The company's own summary says "79 individuals" took part and that time in range rose from 55.5% to 80.3%, without saying that the end figure covers 71 people.

The test that is meant to settle reimbursement is a separate randomised trial. DARE, led by UMC Utrecht and funded by the Promising Care programme of the Dutch National Health Care Institute and ZonMw, compares the Inreda AP with hybrid closed loops and with injection therapy across 14 centres, according to the published protocol. The ClinicalTrials.gov record lists 243 participants and an actual completion date of 15 October 2025, and shows no posted results. A search of PubMed-indexed literature and the company's news page on 4 November 2026 found no published DARE outcome.

What DIABEACON promises

The CORDIS objective is not about the device that is already certified. It describes refining the algorithms, hardware and sensors of an "AP6" device, obtaining "broad regulatory approvals in Europe under MDR Class III", running "large-scale clinical reimbursement trials" on effectiveness and cost savings, expanding the manufacturing site, setting up distribution in key European regions and then moving towards FDA clearance in the United States, with remote monitoring added along the way. The project started on 1 July 2026, CORDIS lists no results yet, and the record gives no total project cost.

1. Refine the AP6 deviceToo earlyNo AP6 specification or result is published; the FAQ says a smaller next model is in development.
2. MDR approval for the new deviceToo earlyThe current AP holds an MDR certificate received on 16 December 2023; no AP6 certificate is announced.
3. Reimbursement trialsUnder wayDARE completed in October 2025 per ClinicalTrials.gov; results not posted.
4. Manufacturing and European distributionNot shownThe device is available only through projects, per the company FAQ.
5. FDA clearanceNot shownNo US filing is announced.

Equity below minus €13 million

The balance sheets show liabilities growing every year since 2022. Liza, which summarises the accounts filed with the Dutch Chamber of Commerce, shows equity of €373,883 at the end of 2022, falling to minus €3.3 million in 2023, minus €7.8 million in 2024 and minus €13.3 million in 2025. Debts grew from €5.7 million to €16.2 million over the same years, while total assets stayed at about €3 million. No revenue or result figure is shown. North Data confirms the filing of balance sheets for 2023, 2024 and 2025, the last on 28 May 2026, and lists no insolvency event.

Who holds the debt is not public. The aggregator Caplight lists a July 2022 venture round led by Wadinko, without an amount; no second source for that round could be found. The EIC selection was for blended finance, which can combine the grant with an EIC Fund investment, but no EIC Fund investment in Inreda has been announced, and CORDIS records only the grant. The company's homepage says "More than 60 people" work at Inreda; the filed accounts give 48 FTE for 2023 and 2024 and 52 for 2025, per Liza.

Where it fits in EU policy

Diabetes is one of the strands of the Commission's Healthier Together initiative on non-communicable diseases, which the Commission launched with €156 million under EU4Health in June 2022. DIABEACON's own case, in its CORDIS objective, is that the device "bolsters Europe's MedTech leadership" and could reduce hospital visits; those are the applicant's claims. One dependency is on the record: the Inreda AP runs on Guardian sensors made by another manufacturer, according to the company FAQ.

Inreda Diabetic has not been asked for comment for this article. The reporting is based on publicly available sources, listed below.