Critical IllnessNCT03890432
GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU)
A study testing GLUCOSAFE 2 in people with Critical Illness and Energy Supply; Deficiency, Severe, run by HEIDEGGER CP at 2 sites in Switzerland.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Energy Supply; Deficiency, Severe, Protein Deficiency
- What is being tested?
- GLUCOSAFE 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 10 Jan 2023to 26 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lack of legal consent or consent withdrawn, except for patients in the historical control group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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Hôpitaux Universitaire de Genève
Geneva, Canton of Geneva, 1205
Service of Intensive Care, Geneva University Hospital,
Geneva, Canton of Geneva, 1211
About this study
Official title: GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study
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.
- Conditions
- Critical Illness, Energy Supply; Deficiency, Severe, Protein Deficiency, Hypoglycemia, Hyperglycemia
- Being tested
- GLUCOSAFE 2, Local protocol control group with routine care, Historical control group with routine care
- Keywords
- Nutrition management, Glycaemia control, ICU, Software, Critical illness, Insulin-therapy, Critically ill patients, Blood glucose control
- Medical subject headings
- Critical Illness, Protein Deficiency, Hypoglycemia, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLUCOSAFE 2Device
Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy
Local protocol control group with routine careDevice
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
Historical control group with routine careDevice
Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
| Study group | Role | What they receive |
|---|---|---|
| GLUCOSAFE 2 | Experimental | Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software. Receives: Device: GLUCOSAFE 2 |
| Local protocol control group | Active comparator | Insulin-therapy and nutrition support guided by the local protocols (electronic or paper version) of the ICU/HUG. Receives: Device: Local protocol control group with routine care |
| Historical control group | Other | Retrospective data with standard care before the beginning of the pilot study in order to minimize the "cross-over" effect due to the fact that caregivers are going to have in charge patients in both groups (intervention and control group) at the same time. Receives: Device: Historical control group with routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time-in-target (range: 5.0 - 8.5 mmol/l)
Time spent in the glycaemia range of 5.0 - 8.5 mmol/l per day, per patient and in the cohort
Measured: During ICU stay, up to 15 days post-randomization.
Secondary outcomes (20)
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events (per patient and in the cohort)
Measured: During ICU stay, up to 15 days post-randomization.
Overall percentage 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 (per patient and in the cohort)
Measured: During ICU stay, up to 15 days post-randomization.
Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance (only in intervention arm)
Measured: During ICU stay, up to 15 days post-randomization.
Percentage 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 (only in intervention arm)
Measured: During ICU stay, up to 15 days post-randomization.
Time to normalize blood glucose (5.0-8.5 mmol/l)
Three values < 8.5 mmol/l as indicator for normalization
Measured: During ICU stay, up to 15 days post-randomization.
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)
Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort.
Measured: During ICU stay, up to 15 days post-randomization.
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance
Percentage of time with BG > 8.5 mmol/l before and after normalization per patient and in the cohort due to non compliance (only in the intervention arm).
Measured: During ICU stay, up to 15 days post-randomization.
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)
Three values < 8.5 mmol/h as indicator for normalization
Measured: From normalization time during ICU stay, up to 15 days post-randomization.
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance
Three values < 8.5 mmol/h as indicator for normalization
Measured: From normalization time during ICU stay, up to 15 days post-randomization.
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 a BG measurements is not followed up within 30 minutes by a request for Glucosafe 2 advice
Measured: During ICU stay, up to 15 days post-randomization.
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 episodes (per patient and in the cohort) when pumps were not set within 30 min according to Glucosafe2 advice accepted by the nurse.
Measured: During ICU stay, up to 15 days post-randomization.
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Measured: During ICU stay, up to 15 days post-randomization.
Frequency of daily and cumulated BG measurements per patient and in the cohort
Frequency of BG measurements (per patient and in the cohort)
Measured: During ICU stay, up to 15 days post-randomization.
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Measured: During ICU stay, up to 15 days post-randomization.
Glycaemic variability
Mean and standard deviation (SD) of blood glucose measurements. Daily maximum blood glucose difference.
Measured: During ICU stay, up to 15 days post-randomization.
Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.
Percentage of proteins received per day and at the end of the ICU stay with a target of 1.3 g/kg of body weight per day.
Measured: During ICU stay, up to 15 days post-randomization.
Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.
Percentage of nutritional and non-nutritional calories received per day and at the end of the ICU stay with a target defined by IC or predictive formula if IC not feasible.
Measured: During ICU stay, up to 15 days post-randomization.
Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)
Per day and at the end of the ICU stay.
Measured: During ICU stay, up to 15 days post-randomization.
Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received
Per day and at the end of the ICU stay.
Measured: During ICU stay, up to 15 days post-randomization.
Prediction of BG
Prediction error as a function of time elapsed since last BG measurement, per patient, per cohort.measurement (per patient and per cohort).
Measured: During ICU stay, up to 15 days post-randomization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start10 Jan 2023
- Primary completion26 Jan 2025
- Study completion26 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- HEIDEGGER CP
- Sponsor type
- University, hospital or other
- Collaborators
- Aalborg University
- Responsible party
- Sponsor-investigator, HEIDEGGER CP, University Hospital, Geneva
- Investigators
- Claudia P. Heidegger, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890432
- Sponsor's protocol ID
- G2-0219
- Status last verified
- Aug 2025
- First submitted
- 14 Feb 2019
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
de Watteville A, Pielmeier U, Di Marco M, Gayet-Ageron A, Siegenthaler N, Parel N, Wozniak H, Primmaz S, Pugin J, Andreassen S, Heidegger CP. Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PLoS One. 2025 Mar 4;20(3):e0316624. doi: 10.1371/journal.pone.0316624. eCollection 2025.
PubMed 40036206
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLUCOSAFE 2 - A New Tool for Nutritional Management and Insulin-therapy in the Intensive Care Unit (ICU): Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03890432
- Acronym / sponsor ID
- G2-0219
- Conditions
- Critical Illness, Energy Supply; Deficiency, Severe, Protein Deficiency, Hypoglycemia, Hyperglycemia
- Keywords
- Nutrition management, Glycaemia control, ICU, Software, Critical illness, Insulin-therapy, Critically ill patients, Blood glucose control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- HEIDEGGER CPUniversity, hospital or other
- Collaborators
- Aalborg University
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 26 Jan 2025 (actual)
- Study completion
- 26 Jan 2025 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GLUCOSAFE 2 | Experimental | Device: GLUCOSAFE 2Insulin-therapy and nutrition support guided by the GLUCOSAFE 2 software. |
| Local protocol control group | Active comparator | Device: Local protocol control group with routine careInsulin-therapy and nutrition support guided by the local protocols (electronic or paper version) of the ICU/HUG. |
| Historical control group | Other | Device: Historical control group with routine careRetrospective data with standard care before the beginning of the pilot study in order to minimize the "cross-over" effect due to the fact that caregivers are going to have in charge patients in both groups (intervention and control group) at the same time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLUCOSAFE 2Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy | Device | GLUCOSAFE 2 |
| Local protocol control group with routine careUse of the local protocols (electronic or paper version) for nutrition management and blood glucose control. | Device | Local protocol control group |
| Historical control group with routine careUse of the local protocols (electronic or paper version) for nutrition management and blood glucose control. | Device | Historical control group |
Primary outcome
Time-in-target (range: 5.0 - 8.5 mmol/l)
Time frame: During ICU stay, up to 15 days post-randomization.
Time spent in the glycaemia range of 5.0 - 8.5 mmol/l per day, per patient and in the cohort
20 secondary outcomes
Overall number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Time frame: During ICU stay, up to 15 days post-randomization.
Overall percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events
Time frame: During ICU stay, up to 15 days post-randomization.
Number of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Time frame: During ICU stay, up to 15 days post-randomization.
Percentage of mild (<3.3 mmol/l) and severe (<2.2 mmol/l) hypoglycemia events due to non-compliance
Time frame: During ICU stay, up to 15 days post-randomization.
Time to normalize blood glucose (5.0-8.5 mmol/l)
Time frame: During ICU stay, up to 15 days post-randomization.
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l)
Time frame: During ICU stay, up to 15 days post-randomization.
Percentage of time in the ICU (per patient and in the cohort) with hyperglycaemia (BG > 8.5 mmol/l) due to non compliance
Time frame: During ICU stay, up to 15 days post-randomization.
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l)
Time frame: From normalization time during ICU stay, up to 15 days post-randomization.
Number of hyperglycemic episodes after normalization (> 8.5 mmol/l) due to non compliance
Time frame: From normalization time during ICU stay, up to 15 days post-randomization.
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
Time frame: During ICU stay, up to 15 days post-randomization.
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.
Time frame: During ICU stay, up to 15 days post-randomization.
Number of advices given by GS2 which were accepted, accepted with modification, or rejected.
Time frame: During ICU stay, up to 15 days post-randomization.
Frequency of daily and cumulated BG measurements per patient and in the cohort
Time frame: During ICU stay, up to 15 days post-randomization.
Frequency of daily and cumulated adjustments of insulin and nutrition pump settings (per patient and in the cohort)
Time frame: During ICU stay, up to 15 days post-randomization.
Glycaemic variability
Time frame: During ICU stay, up to 15 days post-randomization.
Protein goal achievements (80-100% of accumulated target) with a target of 1.3 g/kg of body weight per day.
Time frame: During ICU stay, up to 15 days post-randomization.
Caloric goal achievements (80-100% of the accumulated target) by indirect calorimetry (IC) or predictive formula if IC not feasible.
Time frame: During ICU stay, up to 15 days post-randomization.
Energy debt: difference between the defined energy target (80-100%, defined by IC or predictive formula) and the energy received (nutritional and non-nutritional)
Time frame: During ICU stay, up to 15 days post-randomization.
Protein debt: difference between the defined protein target (1.3 g/kg of body weight/day) and the proteins received
Time frame: During ICU stay, up to 15 days post-randomization.
Prediction of BG
Time frame: During ICU stay, up to 15 days post-randomization.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Derived from this study: PubMed 40036206de Watteville A, Pielmeier U, Di Marco M, Gayet-Ageron A, Siegenthaler N, Parel N, Wozniak H, Primmaz S, Pugin J, Andreassen S, Heidegger CP. Glucosafe 2-A new tool for nutritional management and insulin-therapy in the intensive care unit: Randomized controlled study (the Glucosafe 2 protocol). PLoS One. 2025 Mar 4;20(3):e0316624. doi: 10.1371/journal.pone.0316624. eCollection 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia P. Heidegger, MD principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLUCOSAFE 2 in people with Critical Illness and Energy Supply; Deficiency, Severe, run by HEIDEGGER CP at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time-in-target (range: 5.0 - 8.5 mmol/l) (time frame: During ICU stay, up to 15 days post-randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03890432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025.