Glucose Control in the ICU Using Continuous Glucose Monitoring

Critical Illness Clinical Trial

— REGIMEN  

Official title:

Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799512
• Other study ID #: REGIMEN
• Status: Completed
• Phase: N/A
• First received: February 20, 2013
• Last updated: February 22, 2013
• Start date: July 2007
• Est. completion date: February 2013

Study information

• Verified date: February 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: February 2013
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness

Intervention

Device:
• experimental: real-time continuous glucose monitoring

• Active comparator: blinded continuous glucose monitoring

Locations

Country	Name	City	State
Belgium	Middelheim General Hospital	Antwerp
Belgium	Antwerp University Hospital	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	accuracy of continuous glucose monitoring	error grid analysis, analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	glycaemic fluctuations	standard deviation of mean glucose value over 4 days, analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	accuracy of continuous glucose monitoring	Bland-Altman bias plot will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	accuracy of continuous glucose monitoring	mean absolute error and mean relative error will be evaluated, analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	glycaemic fluctuations	MAGE (mean amplitude of glucose excursions), analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	glycaemic fluctuations	CONGA (continuous overlapping net glycemic action), analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	glycaemic fluctuations	area under curve (within target glycemia range, above target, below target) analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Other	glycaemic fluctuations	MODD: mean of daily differences; analysing all data of the 4 days of continuous glucose monitoring period	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	No
Primary	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	No
Secondary	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	participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU	Yes