Critical IllnessDELIOS 02NCT01233271
Feasibility of Blood Glucose Control With the Space TGC System in Postoperative Cardiac Surgery Patients in the ICU
A study testing Space TGC in people with Critical Illness, run by B. Braun Melsungen AG at 1 site in United Kingdom.
Trial summary
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Space TGC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Apr 2011
- 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 of age
- admitted following cardiac surgery
- stay in the ICU expected to be > 20 h
- blood glucose > 6.7 mmol/l within 4 hours of ICU admission or patient already on insulin treatment
Who cannot join
- patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- known or suspected allergy to insulin
- any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- patients participating in another study
- moribund patients likely to die within 24 hours
- patients after organ transplantation within the last three months
- patients under high dose cortisol treatment (cortisol > 1000 mg/day or equivalent doses of hydrocortisol)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Brompton Hospital, Intensive Care Medicine
London, SW3 6NP
About this study
Official title: Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the ICU
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.
- Conditions
- Critical Illness
- Being tested
- Space TGC
- Keywords
- algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
- Medical subject headings
- Critical Illness, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Space TGCDevice
Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Space TGC system with incorporated eMPC advised insulin titration to establish glycaemic control Receives: Device: Space TGC |
What is being measured
The primary outcome is the main question the study is designed to answer.
(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL
Measured: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Secondary outcomes (3)
Hypoglycaemia ≤ 40 md/dL (2.2mM)
Measured: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Measured: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Measured: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2011
- Study completionApr 2011
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jeremy Cordingley, Dr., Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01233271
- Sponsor's protocol ID
- HC-G-H-0907
- Acronym
- DELIOS 02
- Status last verified
- Jun 2011
- First submitted
- 2 Nov 2010
- Last updated
- 9 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.
PubMed 18661120
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre, Open Study to Investigate the Feasibility of Blood Glucose Control With the Space TGC System (With Incorporated Software-algorithm eMPC) Over an Extended Glucose Control Range (4.4 to 8.3 mmol/L) for a Maximum of 48 Hours in Postoperative Cardiac Surgery Patients in the ICU
- ClinicalTrials.gov ID
- NCT01233271
- Acronym / sponsor ID
- DELIOS 02 / HC-G-H-0907
- Conditions
- Critical Illness
- Keywords
- algorithm, tight glycemic control, glucose control, intensive care, insulin, ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Nov 2010 (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.
Hyperglycemia is common in critically ill patients and associated with an adverse outcome. Thus, glycaemic control is an important issue in critical care. Despite extensive efforts of the intensive care unit staff difficulties were experienced in achieving efficient and safe glucose control. A fully automated algorithm may help to overcome some of these limitations by excluding intuitive interventions and integrating relevant clinical data in the decision-making process. Space GlucoseControl (TGC system) is a decision support system which helps to achieve safe and reliable blood glucose control in the desired ranges. Information on parenteral and enteral nutrition is automatically integrated into the calculations. The primary objective of the current study is to investigate the performance and usability of the Space TGC system for glucose control over an extended glucose control range (4.4 to 8.3 mmol/L) in postoperative cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Space TGCSpace TGC system with incorporated eMPC advised insulin titration to establish glycaemic control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age: > 18 years of age
- admitted following cardiac surgery
- stay in the ICU expected to be > 20 h
- blood glucose > 6.7 mmol/l within 4 hours of ICU admission or patient already on insulin treatment
Key exclusion criteria (7 listed)
- patients with hyperglycaemic crisis/ketoacidosis due to insulin deficiency.
- known or suspected allergy to insulin
- any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient (i.e., liver failure, other fatal organ failures)
- patients participating in another study
- moribund patients likely to die within 24 hours
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 |
|---|---|---|
| Space TGCSpace TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM) | Device | 1 |
Primary outcome
(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL
Time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
3 secondary outcomes
Hypoglycaemia ≤ 40 md/dL (2.2mM)
Time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Usability parameters like convenience of alarming function; workload; blood sampling frequency
Time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
Concomitant medication including insulin infusion rate, parenteral/enteral nutrition
Time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h
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 9 Jun 2011.
- Background: PubMed 18661120Cordingley JJ, Vlasselaers D, Dormand NC, Wouters PJ, Squire SD, Chassin LJ, Wilinska ME, Morgan CJ, Hovorka R, Van den Berghe G. Intensive insulin therapy: enhanced Model Predictive Control algorithm versus standard care. Intensive Care Med. 2009 Jan;35(1):123-8. doi: 10.1007/s00134-008-1236-z. Epub 2008 Jul 26.
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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.
Jeremy Cordingley, Dr. principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Space TGC in people with Critical Illness, run by B. Braun Melsungen AG at 1 site in United Kingdom.
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 7 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 9 Jun 2011. 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 United Kingdom. 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?
(arterial) blood glucose values -> percentage of time within predefined glucose target range 4.4-8.3 mmol/dL (time frame: all blood glucose measurements from start of treatment until last glucose measurement under treatment (i.e. stop of intravenous insulin treatment) up to a maximum of 48h). 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 NCT01233271, 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 9 Jun 2011.