Clinical trial NCT01799512: Glucose Control in the ICU Using Continuous Glucose Monitoring
Official title: Randomized Evaluation of Glycaemic Control in the Medical Intensive Care Unit Using Continuous Glucose Monitoring (REGIMEN Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Keywords: medical ICU patients
APACHE-II score ≥20
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: percentage of time that patients are in target range of glycaemia (80-110 mg/dl)
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Secondary outcomes:
measure: percentage of time that patients are in hypoglycaemic range
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Other outcomes:
measure: accuracy of continuous glucose monitoring
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: glycaemic fluctuations
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: accuracy of continuous glucose monitoring
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: accuracy of continuous glucose monitoring
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: glycaemic fluctuations
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: glycaemic fluctuations
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: glycaemic fluctuations
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
measure: glycaemic fluctuations
timeFrame: participants will be followed for 96 hours (4 days), during the first week after admission to the medical ICU
Locations:
city: Antwerp
country: Belgium
facility: Middelheim General Hospital
city: Edegem
country: Belgium
facility: Antwerp University Hospital
Study officials:
affiliation: Antwerp University Hospital, Dept of Endocrinology, Diabetology & Metabolism
name: Christophe De Block, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.