Disorder of Glucose RegulationGluCipNCT02594865
The Glycaemic Effects of Glucerna® in Critically Ill Patients.
A study testing Glucerna and Fresubin in people with Disorder of Glucose Regulation, run by PHJ van der Voort at 1 site in Netherlands.
Trial summary
To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disorder of Glucose Regulation
- What is being tested?
- Glucerna and Fresubin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2015to Jun 2016
- 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
- Age ≥ 18 years;
- Patients with an anticipated stay of at least 48 hours of admission to the intensive care
- Expected to receive enteral feeding for at least 48 hrs
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Patient or surrogate understands and signs informed consent document.
Who cannot join
- Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system
- Patients previously randomised into the GluCip trial
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Onze Lieve Vrouwe Gasthuis
Amsterdam, North Holland, 1091 AC
About this study
Official title: Glucerna in Critically Ill Patients (GluCip Trial): Investigating the Glycaemic Effects of a Reduced-carbohydrate, Modified-fat, Fiber-containing Enteral Formula (Glucerna®) in Critically Ill Patients.
To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.
- Conditions
- Disorder of Glucose Regulation
- Being tested
- Glucerna, Fresubin
- Keywords
- Enteral Nutrition, Continuous Glucose Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucernaDietary supplement
Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
FresubinDietary supplement
Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
| Study group | Role | What they receive |
|---|---|---|
| Glucerna | Active comparator | Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. Receives: Dietary Supplement: Glucerna |
| Fresubin | Active comparator | Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. Receives: Dietary Supplement: Fresubin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability
The primary outcome is the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr.
Measured: 72 hours
Secondary outcomes (9)
Amount of insulin use
In units/day.
Measured: 72 hours
Time in target range
Defined as a glucose between 6-9 mmol/l in minutes/day.
Measured: 72 hours
Mean glucose and standarddeviation
Defined as the mean sensor glucose and standarddeviation in mmol/l.
Measured: 72 hours
Number of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l.
Measured: 72 hours
Duration of severe hypoglycemic events
Hypoglycemic event is defined as a sensor glucose below 2.2 mmol/l. Duration is measured in minutes/day.
Measured: 72 hours
Number of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l.
Measured: 72 hours
Duration of severe hyperglycemic events
Hyperglycemic event is defined as a sensor glucose above 15.0 mmol/l. Duration is measured in minutes/day.
Measured: 72 hours
Daily calorie administration
Defined as amount of calories received per patient/day.
Measured: 72 hours
Daily nutrient administration
Defined as amount of nutrients (carbohydrates, fat, proteins) received per patient/day.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorder of Glucose RegulationStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- PHJ van der Voort
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PHJ van der Voort, Onze Lieve Vrouwe Gasthuis
- Investigators
- Peter HJ van der Voort, Prof. dr., Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02594865
- Sponsor's protocol ID
- NL51918.100.14
- Acronym
- GluCip
- Status last verified
- Jun 2016
- First submitted
- 16 Sep 2015
- Last updated
- 27 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucerna in Critically Ill Patients (GluCip Trial): Investigating the Glycaemic Effects of a Reduced-carbohydrate, Modified-fat, Fiber-containing Enteral Formula (Glucerna®) in Critically Ill Patients.
- ClinicalTrials.gov ID
- NCT02594865
- Acronym / sponsor ID
- GluCip / NL51918.100.14
- Conditions
- Disorder of Glucose Regulation
- Keywords
- Enteral Nutrition, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- PHJ van der VoortUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Study start
- Sep 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Nov 2015 (estimated)
- 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.
To investigate whether the administration of Glucerna achieves less glycaemic variability, defined as the mean absolute glucose (MAG) change, and better glycaemic control compared to a standard high-carbohydrate enteral formula. Continuous glucose monitoring technology will be used to evaluate glycaemic variability and glycaemic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucerna | Active comparator | Dietary Supplement: GlucernaGlucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. |
| Fresubin | Active comparator | Dietary Supplement: FresubinFresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Patients with an anticipated stay of at least 48 hours of admission to the intensive care
- Expected to receive enteral feeding for at least 48 hrs
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Patient or surrogate understands and signs informed consent document.
Key exclusion criteria (3 listed)
- Patients with pre-existing contraindications to enteral feeding or to placement of a continuous glucose monitoring system
- Patients previously randomised into the GluCip trial
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient.
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 |
|---|---|---|
| GlucernaGlucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding. | Dietary supplement | Glucerna |
| FresubinFresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding. | Dietary supplement | Fresubin |
Primary outcome
Glucose variability
Time frame: 72 hours
The primary outcome is the extent of glucose variability, defined as the mean absolute glucose (MAG) change (delta glucose/delta time) in mmol/l/hr.
9 secondary outcomes
Amount of insulin use
Time frame: 72 hours
Time in target range
Time frame: 72 hours
Mean glucose and standarddeviation
Time frame: 72 hours
Number of severe hypoglycemic events
Time frame: 72 hours
Duration of severe hypoglycemic events
Time frame: 72 hours
Number of severe hyperglycemic events
Time frame: 72 hours
Duration of severe hyperglycemic events
Time frame: 72 hours
Daily calorie administration
Time frame: 72 hours
Daily nutrient administration
Time frame: 72 hours
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 27 Jun 2016.
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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.
Peter HJ van der Voort, Prof. dr. principal investigator
Onze Lieve Vrouwe Gasthuis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucerna and Fresubin in people with Disorder of Glucose Regulation, run by PHJ van der Voort at 1 site in Netherlands.
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 5 inclusion and 3 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 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
Glucose variability (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jun 2016.