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Glucose Control in the ICU Using Continuous Glucose Monitoring (REGIMEN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799512
Recruitment Status : Completed
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Christophe De Block, University Hospital, Antwerp

Brief Summary:

Stress hyperglycemia occurs in 50-85% of patients admitted to a medical intensive care unit (MICU) and is associated with increased morbidity and mortality. However, randomized controlled trials examining the effects of strict glycemic control demonstrated conflicting results. A common finding in these trials was the high risk of hypoglycaemia.

This randomized controlled trial evaluates the impact of real-time continuous glucose monitoring (RT-CGM) on glycemic control and risk of hypoglycemia in severely ill MICU patients with an APACHE-II (Acute Physiology and Chronic Health Evaluation II) score ≥20.


Condition or disease Intervention/treatment Phase
Critical Illness Device: experimental: real-time continuous glucose monitoring Device: Active comparator: blinded continuous glucose monitoring Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)
Study Start Date : July 2007
Actual Primary Completion Date : September 2010
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: real-time continuous glucose monitoring

real-time continuous glucose monitoring: Use will be made of the online real-time (RT) monitoring facility of the GlucoDay® (a continuous glucose monitoring (CGM)system). This will allow immediate adaptation of the insulin dose in order to maintain values within an optimal range.

The same IV insulin infusion protocol will be used in the experimental and the active comparator group (adapted Yale protocol).

When glycaemic changes of >25 mg/dl per 30 minutes are observed from the RT-CGM - GlucoDay data, this will be checked by measuring arterial blood glucose and the insulin infusion rate will be adapted according to the adapted Yale protocol.

Device: experimental: real-time continuous glucose monitoring
Other Name: RT-CGM using the GlucoDay device (A. Menarini, Italy)

Active Comparator: blinded continuous glucose monitoring

In the active comparator group the same continuous glucose monitoring device (GlucoDay) will be used in a blinded fashion. Glucose data will be analysed retrospectively.

IV insulin infusion will be adapted according to arterial blood glucose values, using the adapted Yale protocol.

Device: Active comparator: blinded continuous glucose monitoring



Primary Outcome Measures :
  1. percentage of time that patients are in target range of glycaemia (80-110 mg/dl) [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU


Secondary Outcome Measures :
  1. percentage of time that patients are in hypoglycaemic range [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    after admission to the ICU, patients will be screened to check inclusion criteria, and CGM monitoring will commence within the first 48hrs after admission. CGM monitoring will be performed during 96 hours (4 days), during the first week after admission to the medical ICU


Other Outcome Measures:
  1. accuracy of continuous glucose monitoring [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period

  2. glycaemic fluctuations [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period

  3. accuracy of continuous glucose monitoring [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    Bland-Altman bias plot will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period

  4. accuracy of continuous glucose monitoring [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    mean absolute error and mean relative error will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period

  5. glycaemic fluctuations [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    MAGE (mean amplitude of glucose excursions), analysing all data of the 4 days of continuous glucose monitoring period

  6. glycaemic fluctuations [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    CONGA (continuous overlapping net glycemic action), analysing all data of the 4 days of continuous glucose monitoring period

  7. glycaemic fluctuations [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    area under curve (within target glycemia range, above target, below target) analysing all data of the 4 days of continuous glucose monitoring period

  8. glycaemic fluctuations [ Time Frame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU ]
    MODD: mean of daily differences; analysing all data of the 4 days of continuous glucose monitoring period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted to a medical intensive care unit
  • age: ≥ 18 y , < 75 y
  • APACHE II (Acute Physiology and Chronic Health Evaluation II) score ≥ 20
  • expected length of stay in ICU > 3 days

Exclusion Criteria:

  • pregnancy
  • patient with a DNR (do not reanimate) code
  • surgical patient
  • no informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799512


Locations
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Belgium
Middelheim General Hospital
Antwerp, Belgium, 2020
Antwerp University Hospital
Edegem, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Christophe De Block, MD PhD Antwerp University Hospital, Dept of Endocrinology, Diabetology & Metabolism
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christophe De Block, MD PhD, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01799512    
Other Study ID Numbers: REGIMEN
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Christophe De Block, University Hospital, Antwerp:
medical ICU patients
APACHE-II score ≥20
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes