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

Primary Purpose

Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
experimental: real-time continuous glucose monitoring
Active comparator: blinded continuous glucose monitoring
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring medical ICU patients, APACHE-II score ≥20

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Middelheim General Hospital
  • Antwerp University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

real-time continuous glucose monitoring

blinded continuous glucose monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
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

percentage of time that patients are in hypoglycaemic range
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

Full Information

First Posted
February 20, 2013
Last Updated
February 22, 2013
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT01799512
Brief Title
Glucose Control in the ICU Using Continuous Glucose Monitoring
Acronym
REGIMEN
Official Title
Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
medical ICU patients, APACHE-II score ≥20

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real-time continuous glucose monitoring
Arm Type
Experimental
Arm Description
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.
Arm Title
blinded continuous glucose monitoring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
experimental: real-time continuous glucose monitoring
Other Intervention Name(s)
RT-CGM using the GlucoDay device (A. Menarini, Italy)
Intervention Type
Device
Intervention Name(s)
Active comparator: blinded continuous glucose monitoring
Primary Outcome Measure Information:
Title
percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
Description
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
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Secondary Outcome Measure Information:
Title
percentage of time that patients are in hypoglycaemic range
Description
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
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Other Pre-specified Outcome Measures:
Title
accuracy of continuous glucose monitoring
Description
error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
glycaemic fluctuations
Description
standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
accuracy of continuous glucose monitoring
Description
Bland-Altman bias plot will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
accuracy of continuous glucose monitoring
Description
mean absolute error and mean relative error will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
glycaemic fluctuations
Description
MAGE (mean amplitude of glucose excursions), analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
glycaemic fluctuations
Description
CONGA (continuous overlapping net glycemic action), analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
glycaemic fluctuations
Description
area under curve (within target glycemia range, above target, below target) analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Title
glycaemic fluctuations
Description
MODD: mean of daily differences; analysing all data of the 4 days of continuous glucose monitoring period
Time Frame
participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe De Block, MD PhD
Organizational Affiliation
Antwerp University Hospital, Dept of Endocrinology, Diabetology & Metabolism
Official's Role
Principal Investigator
Facility Information:
Facility Name
Middelheim General Hospital
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
Antwerp University Hospital
City
Edegem
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
16873775
Citation
De Block C, Manuel-Y-Keenoy B, Van Gaal L, Rogiers P. Intensive insulin therapy in the intensive care unit: assessment by continuous glucose monitoring. Diabetes Care. 2006 Aug;29(8):1750-6. doi: 10.2337/dc05-2353.
Results Reference
background
PubMed Identifier
18690906
Citation
De Block C, Manuel-y-Keenoy B, Rogiers P, Jorens P, Van Gaal L. Glucose control and use of continuous glucose monitoring in the intensive care unit: a critical review. Curr Diabetes Rev. 2008 Aug;4(3):234-44. doi: 10.2174/157339908785294460.
Results Reference
background
PubMed Identifier
14747229
Citation
Goldberg PA, Siegel MD, Sherwin RS, Halickman JI, Lee M, Bailey VA, Lee SL, Dziura JD, Inzucchi SE. Implementation of a safe and effective insulin infusion protocol in a medical intensive care unit. Diabetes Care. 2004 Feb;27(2):461-7. doi: 10.2337/diacare.27.2.461.
Results Reference
background
PubMed Identifier
22138078
Citation
Shetty S, Inzucchi SE, Goldberg PA, Cooper D, Siegel MD, Honiden S. Adapting to the new consensus guidelines for managing hyperglycemia during critical illness: the updated Yale insulin infusion protocol. Endocr Pract. 2012 May-Jun;18(3):363-70. doi: 10.4158/EP11260.OR.
Results Reference
background
PubMed Identifier
20007948
Citation
Holzinger U, Warszawska J, Kitzberger R, Wewalka M, Miehsler W, Herkner H, Madl C. Real-time continuous glucose monitoring in critically ill patients: a prospective randomized trial. Diabetes Care. 2010 Mar;33(3):467-72. doi: 10.2337/dc09-1352. Epub 2009 Dec 10.
Results Reference
background
PubMed Identifier
26305390
Citation
De Block CE, Gios J, Verheyen N, Manuel-y-Keenoy B, Rogiers P, Jorens PG, Scuffi C, Van Gaal LF. Randomized Evaluation of Glycemic Control in the Medical Intensive Care Unit Using Real-Time Continuous Glucose Monitoring (REGIMEN Trial). Diabetes Technol Ther. 2015 Dec;17(12):889-98. doi: 10.1089/dia.2015.0151. Epub 2015 Aug 25.
Results Reference
derived

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Glucose Control in the ICU Using Continuous Glucose Monitoring

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