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NCT03890432
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)
NA trial testing GLUCOSAFE 2 in Critical Illness in 213 participants. Completed in 26 January 2025.
26 January 2025
Quick facts
| Lead sponsor | HEIDEGGER CP |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 213 |
| Start date | 10 January 2023 |
| Primary completion | 26 January 2025 |
| Estimated completion | 26 January 2025 |
| Sites | 2 locations across Switzerland |
Drugs / interventions tested
- GLUCOSAFE 2
- Local protocol control group with routine care
- Historical control group with routine care
Conditions studied
- Critical Illness — all drugs for Critical Illness →
- Energy Supply; Deficiency, Severe — all drugs for Energy Supply; Deficiency, Severe →
- Protein Deficiency — all drugs for Protein Deficiency →
- Hypoglycemia — all drugs for Hypoglycemia →
Sponsor
HEIDEGGER CP
Who can join
18 and older, any sex, with Critical Illness or Energy Supply; Deficiency, Severe. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The survival and the outcomes of critically ill patients are strongly influenced by insulin-therapy and nutritional support. The GLUCOSAFE 2 pilot study, aims to test the performance and the security of the new GLUCOSAFE 2 software, developed by the model-based medical decision support of Aalborg University (Denmark) and adapted to the clinical needs in the intensive care unit (ICU) of the Geneva University Hospital (HUG). This new device is based on a mathematical model of the glucose-insulin metabolism and attempts to give advices for better glycaemia control and nutritional therapy. The GLUCOSAFE 2 study hypothesizes that the use of the Glucosafe 2 software will allow better glycaemia ("Time-in-target") control and better achievement of nutritional energy and protein targets in comparison to the local protocols.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol).
de Watteville A, Pielmeier U, Di Marco M, Gayet-Ageron A, et al · · 2025 · PMID 40036206 · DOI 10.1371/journal.pone.0316624
Verify or expand the search:
- PubMed search for NCT03890432
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other HEIDEGGER CP trials
Trials by the same sponsor.
- NCT07343440 — Trial on the Impact of Indirect Calorimetry-Guided Nutritional Support on Patient-Centered Outcomes in Critically Ill Pa · NA · not yet recruiting
- NCT05865314 — Optimised Nutritional Therapy and Early Physiotherapy in Long Term ICU Patients (NutriPhyT Trial) · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03890432 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by HEIDEGGER CP
- Last refreshed: 12 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03890432.
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