NCT01799512

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2013

Completed
Last Updated

February 26, 2013

Status Verified

February 1, 2013

Enrollment Period

3.2 years

First QC Date

February 20, 2013

Last Update Submit

February 22, 2013

Conditions

Critical Illness

Keywords

medical ICU patientsAPACHE-II score ≥20

Outcome Measures

Primary Outcomes (1)

  • 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

    participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

Secondary Outcomes (1)

  • percentage of time that patients are in hypoglycaemic range

    participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

Other Outcomes (8)

  • accuracy of continuous glucose monitoring

    participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

  • glycaemic fluctuations

    participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

  • accuracy of continuous glucose monitoring

    participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU

  • +5 more other outcomes

Study Arms (2)

real-time continuous glucose monitoring

EXPERIMENTAL

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

blinded continuous glucose monitoring

ACTIVE COMPARATOR

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

Interventions

experimental: real-time continuous glucose monitoringDEVICE
Also known as: RT-CGM using the GlucoDay device (A. Menarini, Italy)
real-time continuous glucose monitoring
Active comparator: blinded continuous glucose monitoringDEVICE
blinded continuous glucose monitoring

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Middelheim General Hospital

Antwerp, 2020, Belgium

Location

Antwerp University Hospital

Edegem, 2650, Belgium

Location

Related Publications (6)

  • 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.

    PMID: 16873775BACKGROUND

  • 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.

    PMID: 18690906BACKGROUND

  • 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.

    PMID: 14747229BACKGROUND

  • 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.

    PMID: 22138078BACKGROUND

  • 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.

    PMID: 20007948BACKGROUND

  • 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.

    PMID: 26305390DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe De Block, MD PhD

    Antwerp University Hospital, Dept of Endocrinology, Diabetology & Metabolism

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

February 20, 2013

First Posted

February 26, 2013

Study Start

July 1, 2007

Primary Completion

September 1, 2010

Study Completion

February 1, 2013

Last Updated

February 26, 2013

Record last verified: 2013-02

Locations

BE(2)