Glucosafe 2 - A new tool for nutritional monitoring and insulin therapy in adult intensive care: a randomized controlled study
Descrizione riassuntiva dello studio
The aim of this study is to evaluate the safety and performance of a new software, Glucosafe 2, developed by Aalborg University (Denmark) and to compare its use with the standard protocols of adult intensive care at HUG. The study is conducted in the adult intensive care unit at HUG as the sole center and will include 71 patients per group (intervention/control and historical control). The duration of the study corresponds to the length of stay of the patient in intensive care with a maximum duration of 15 days. Patients agreeing to participate will be randomly assigned (50 %-50 %) to the intervention group (use of the Glucosafe 2 software) or to the control group (use of the standard service protocols). Data from 71 patients who were hospitalized in intensive care 2 years prior to the start of the study will also be collected (historical control group) to minimize bias due to possible interactions between the intervention group and the control group.
(BASEC)
Intervento studiato
The Glucosafe 2 software is designed to guide caregivers (nurses and physicians) in managing insulin therapy as well as nutrition. It is based on the mathematical algorithm of glucose-insulin metabolism. This model integrates the following data: body weight, age, gender, type of diabetes, dialysis, blood glucose measurements, insulin therapy, and nutritional support (including non-nutritive calories). Based on this data, the software can calculate the patient's insulin sensitivity, predict the patient's future blood glucose over a period of 4 hours, and make suggestions for adjusting insulin and nutritional doses. The caregivers in charge of the patient can then decide whether or not to follow the adaptations proposed by the software.
(BASEC)
Malattie studiate
The survival and clinical outcome of severely injured patients hospitalized in adult intensive care are influenced by nutritional management and blood glucose monitoring. Medical and care advances have led to a decrease in complications as well as mortality in these patients. However, physical and physiological impairments in severely injured patients may persist long-term after the stay in intensive care. In this context, experts recommend an individualized management plan that includes nutritional therapy, blood glucose control, and early mobilization.
(BASEC)
All patients aged ≥ 18 years admitted to the adult intensive care unit of the University Hospitals of Geneva (HUG) with: - A planned length of stay ≥ 72h - At least 1 blood glucose measurement (BG) ≥10 mmol/l or 2 BG measurements ≥ 8.5 mmol/l. - Informed consent signed by the subject/legal representative, except for patients in the historical control group. (BASEC)
Criteri di esclusione
- Absence of legal consent or withdrawal of consent, except for patients in the historical control group. - Pregnancy or breastfeeding - Diabetic ketoacidosis or hyperosmolar state - Oral feeding - Fulminant liver disease - Medical contraindication to receive rapid-acting insulin by intravenous infusion (iv) or iv injection (BASEC)
Luogo dello studio
Ginevra
(BASEC)
Sponsor
Geneva University Hospitals
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Heidegger Claudia-Paula
+41 22 37 27 440
claudia.heidegger@clutterhcuge.chGeneva University Hospitals
(BASEC)
Informazioni generali
University Hospital, Geneva,
+ 41 22 37 27 440;
claudia.heidegger@clutterhcuge.ch(ICTRP)
Informazioni generali
University Hospital, Geneva
(ICTRP)
Informazioni scientifiche
University Hospital, Geneva,
+ 41 22 37 27 440;
claudia.heidegger@clutterhcuge.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Ginevra
(BASEC)
Data di approvazione del comitato etico
21.12.2021
(BASEC)
ID di studio ICTRP
NCT03890432 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Glucosafe 2 - A new tool for nutritional management and insulin-therapy in the intensive care unit: randomized controlled study (BASEC)
Titolo accademico
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study (ICTRP)
Titolo pubblico
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU) (ICTRP)
Malattie studiate
Critical IllnessEnergy Supply Deficiency, SevereProtein DeficiencyHypoglycemiaHyperglycemia (ICTRP)
Intervento studiato
Device: GLUCOSAFE 2Device: Local protocol control group with routine careDevice: Historical control group with routine care (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
Inclusion Criteria:
All patients = 18 years admitted to the ICU with
- An expected length of stay = 72h
- At least 1 blood glucose (BG) measurement =10 mmol/l or 2 BG measurement = 8.5
mmol/l
- Informed Consent signed by the subject/ legal representative, except for patients in
the historical control group
Exclusion Criteria:
- Lack of legal consent or consent withdrawn, except for patients in the historical
control group
- Pregnant or breast feeding
- Diabetic ketoacidosis or hyperosmolar state
- Oral feeding
- Fulminant hepatic failure
- Medically contraindicated to receive rapidly acting insulin by intravenous (iv)
infusion or iv injection (ICTRP)
non disponibile
Endpoint primari e secondari
Time-in-target (range: 5.0 - 8.5 mmol/l) (ICTRP)
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events;Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events;Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance;Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance;Time to normalize blood glucose (5.0-8.5 mmol/l);Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l);Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance;Number of hyperglycemic episodes after normalization (> 8.5 mmol/l);Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance;Number of episodes (per patient and in the cohort) where a BG measurements is not followed up within 30 minutes by a request for Glucosafe 2 advice;Number of episodes (per patient and in the cohort) where pumps were not set within 30 min according to Glucosafe2 advice accepted by the nurse.;Number of advices given by GS2 which were accepted, accepted with modification, or rejected.;Frequency of daily and cumulated BG measurements per patient and in the cohort;Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort);Glycaemic variability;Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.;Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.;Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional);Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received;Prediction of BG (ICTRP)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Aalborg University (ICTRP)
Contatti aggiuntivi
Claudia P. Heidegger, MD;Claudia P. Heidegger, MD;Claudia Heidegger, MD, claudia.heidegger@hcuge.ch, + 41 22 37 27 440;, University Hospital, Geneva, (ICTRP)
ID secondari
G2-0219 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/study/NCT03890432 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
lay-summary-of-the-study-results-v1-23-01-2026.pdfLink ai risultati nel registro primario
non disponibile