HyperglycaemiaRESCUEIINCT01526044
Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients
A study testing Freestyle Navigator in people with Hyperglycaemia and Hypoglycaemia, run by Onze Lieve Vrouwe Gasthuis at 1 site in Netherlands.
Trial summary
The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperglycaemia, Hypoglycaemia
- What is being tested?
- Freestyle Navigator
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2010to Jun 2012
- 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
- ICU-patients > 18 years
- Expected length of stay on the ICU > 24 hours
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Availability of the Freestyle Navigator
Who cannot join
- Participation in another trial subject to the WMO
- Lack of informed consent
- Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
- Contraindication for placement of the subcutaneous glucose sensor
- Participation in this trial during previous ICU admittance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)
The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.
Read the detailed description
Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:
- Better insight in the alterations of the blood glucose levels
- Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
- Fewer blood samples
- Decreased workload for the nursing staff
In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.
Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.
The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.
In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.
Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.
- Conditions
- Hyperglycaemia, Hypoglycaemia
- Being tested
- Freestyle Navigator
- Keywords
- hyperglycemia, hypoglycemia, insulin, critical illness, intensive insulin therapy, continuous glucose monitoring, CGM, interstitial fluid glucose, intensive care unit, Blood glucose
- Medical subject headings
- Hyperglycemia, Hypoglycemia, Insulin Resistance, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle NavigatorDevice
Also called Freestyle Navigator, Abbott Diabetes Care
Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
| Study group | Role | What they receive |
|---|---|---|
| Freestyle group | Experimental | Glucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU Receives: Device: Freestyle Navigator |
| AccuChek group | Active comparator | Glucose levels are being measured by the AccuChek. Patients also get a Freestyle Navigator, which will be blinded. The device will stay on the patient up to 5 days, or until discharge from the ICU. Receives: Device: Freestyle Navigator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
Secondary outcomes (9)
Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
The target range in the ICU of the OLVG is set between 5 and 9 mmol/l according to the local treatment protocol
- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
Mean Absolute Glucose change per hour:
ΔBGA / Δtime The MAG is calculated by taking the sum of all absolute glucose changes during admission (measured by BGA) and dividing this by the total time spent in the ICU in hours.
Length of stay in the ICU
Mortality
False positive frequency of alarms of the Freestyle Navigator®
Verified by the glucose level measurements by blood gas analyzer
Number of undesirable low glucose levels per 24 hours
blood glucose levels between 2,5 and 5 mmol/l
Measured: 24 hours
Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
Number of blood samples per day
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completionJun 2012
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 HyperglycaemiaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onze Lieve Vrouwe Gasthuis
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PHJ van der Voort, Onze Lieve Vrouwe Gasthuis
- Investigators
- P HJ van der Voort, MD, PhD, Principal investigator, Onze Lieve Vrouwe Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526044
- Sponsor's protocol ID
- NL33495.100.10
- Acronym
- RESCUEII
- Status last verified
- Jun 2012
- First submitted
- 1 Feb 2012
- Last updated
- 27 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.
PubMed 25139609
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring by Subcutaneous Measurement Compared to Frequent Point of Care Measurement by Accu Chek in Critically Ill Patients; a Randomized Controlled Trial (RESCUEII)
- ClinicalTrials.gov ID
- NCT01526044
- Acronym / sponsor ID
- RESCUEII / NL33495.100.10
- Conditions
- Hyperglycaemia, Hypoglycaemia
- Keywords
- hyperglycemia, hypoglycemia, insulin, critical illness, intensive insulin therapy, continuous glucose monitoring, CGM, interstitial fluid glucose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Onze Lieve Vrouwe GasthuisUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 3 Feb 2012 (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.
The purpose of this study is to evaluate the accuracy and reliability of the continuous glucose monitoring system the FreeStyle Navigator® (Abbott, Diabetes Care) in critically ill patients by comparing subcutaneous measuring with the current standard of arterial measuring by a point of care glucometer.
Detailed description
Most patients admitted to the ICU are treated with intensive insulin therapy, according to a locally developed glucose treatment protocol. The use of a continuous glucose monitoring in critically ill patients could have the following advantages:
- Better insight in the alterations of the blood glucose levels
- Early detection of hypoglycemia's or hyperglycaemia's, and subsequently more stable glycemic levels.
- Fewer blood samples
- Decreased workload for the nursing staff
In this study, patients will be randomized in: 1. The Freestyle group or 2. The AccuChek Group.
Patients in both groups will receive a Freestyle Navigator device, which will stay on the patient up to 5 days, or until discharge from the ICU.
The medical treatment of both study groups will be equal, except for the frequency of the glucose level measurements and the resulting adjustments according to the treatment protocol. In the Freestyle group extra glucose level measurements will be made in response to alarms from the device.
In both groups, every 4 hours blood glucose values will be obtained using a blood gas analyzer (BGA). When a control measurement by BGA results in a glucose level of <2.2 or >25 mmol/l, the value will be transmitted to the Patient Data Management System (PDMS) and gives an alarm. Otherwise, the value will be blinded in the PDMS.
Freestyle Navigator data will be downloaded from the device. Blood glucose values obtained in the course of usual care will be compared with time-matched Freestyle Navigator values to assess device accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freestyle group | Experimental | Device: Freestyle NavigatorGlucose levels are being monitored with the Freestyle Navigator up to 5 days, or until discharge from the ICU |
| AccuChek group | Active comparator | Device: Freestyle NavigatorGlucose levels are being measured by the AccuChek. Patients also get a Freestyle Navigator, which will be blinded. The device will stay on the patient up to 5 days, or until discharge from the ICU. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ICU-patients > 18 years
- Expected length of stay on the ICU > 24 hours
- Indication for glucose regulation with insulin (according to the current glucose treatment protocol)
- Availability of the Freestyle Navigator
Key exclusion criteria (5 listed)
- Participation in another trial subject to the WMO
- Lack of informed consent
- Contraindication for the use of the Accu Chek (for example peritoneal dialysis, Ht <0,20 of > 0,65; paracetamol intoxication)
- Contraindication for placement of the subcutaneous glucose sensor
- Participation in this trial during previous ICU admittance
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 |
|---|---|---|
| Freestyle NavigatorAlso: Freestyle Navigator, Abbott Diabetes CareContinuous glucose monitoring by subcutaneous measurement in the interstitial fluid | Device | AccuChek group, Freestyle group |
Primary outcome
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l
9 secondary outcomes
Time duration that the blood glucose levels of a patient are within the 'target range' (measured with the freestyle Navigator®)
Time duration that the blood glucose levels of a patient are under and above the 'target range' (measured with the freestyle Navigator®)
- Variability of the glycemic levels by arterial measuring with the blood gas analyzer (BGA), determined by the Mean Absolute Glucose change per hour (MAG)
Length of stay in the ICU
Mortality
False positive frequency of alarms of the Freestyle Navigator®
Number of undesirable low glucose levels per 24 hours
Time frame: 24 hours
Number of missed hypoglycemia's with the AccuChek (measured with the Freestyle Navigator®)
Number of blood samples per day
Time frame: 24 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 2012.
- Derived from this study: PubMed 25139609Boom DT, Sechterberger MK, Rijkenberg S, Kreder S, Bosman RJ, Wester JP, van Stijn I, DeVries JH, van der Voort PH. Insulin treatment guided by subcutaneous continuous glucose monitoring compared to frequent point-of-care measurement in critically ill patients: a randomized controlled trial. Crit Care. 2014 Aug 20;18(4):453. doi: 10.1186/s13054-014-0453-9.
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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.
P HJ van der Voort, MD, PhD 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 Freestyle Navigator in people with Hyperglycaemia and Hypoglycaemia, run by Onze Lieve Vrouwe Gasthuis 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 4 inclusion and 5 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 2012. 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?
Number of severe hyperglycaemias and hypoglycaemias with blood glucose levels >25 mmol/l and <2.2 mmol/l. 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 NCT01526044, 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 27 Jun 2012.