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Closing the Loop In Critical Care

Objectif

Dysglycaemia affects 75% of critical care patients and increases 30-day mortality up to fivefold. Glucose clamping at normoglycaemia reduces mortality by 29%, serious infections by 53%, and major cardiovascular events by 43%, but has never entered clinical practice because no reliable real-time intravascular glucose sensor has existed. GlucoClamp is the first automated closed-loop glucose control system designed for critical care: an intravascular optical sensor placed through an existing arterial catheter feeds real-time glucose values into a software controller that adjusts IV glucose infusion automatically, while insulin remains under nurse control.

CLICC is a 22-month project advancing GlucoClamp from TRL 6 to TRL 8 with five objectives: (1) transfer sensor manufacturing to a qualified contract manufacturer and validate a scalable production process; (2) finalise and freeze IEC 62304-compliant GlucoClamp software; (3) complete MDR-compliant validation including a first-in-human closed-loop clinical investigation in 30 cardiac and abdominal surgery patients; (4) compile the full MDR Annex II/III technical file for CE-mark submission; and (5) protect foreground IP via 3 PCT applications, confirm FDA 510(k) and PMDA regulatory pathways, and secure a signed commercial agreement with the identified pilot customer.

An EIC grant of EUR 2.5M de-risks the EUR 19M private investment needed for subsequent market entry across EU, US and Japan, directly serving the EIC Work Programme priority for breakthrough medical technologies with proven clinical benefit and scalable commercial impact.

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Mots‑clés

Programme(s)

Thème(s)

Régime de financement

HORIZON-EIC-ACC - HORIZON EIC Accelerator

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Appel à propositions

(s’ouvre dans une nouvelle fenêtre) HORIZON-EIC-2026-ACCELERATOR-02

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Coordinateur

GLUCOSET AS
Contribution nette de l'UE
€ 2 499 998,07
Adresse
SLUPPENVEGEN 6
7037 Oslo
Norvège
PME
Oui
Région
Norge Trøndelag Trøndelag
Type d’activité
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Liens
Coût total
Aucune donnée