Completed

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

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What is being tested

experimental: real-time continuous glucose monitoring

+ Active comparator: blinded continuous glucose monitoring

Device
Who is being recruted

Pathologic Processes+1

+ Pathological Conditions, Signs and Symptoms

+ Disease Attributes

From 18 to 75 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2007
See protocol details

Summary

Principal SponsorUniversity Hospital, Antwerp
Last updated: February 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2007

Actual date on which the first participant was enrolled.

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.

NCT01799512
Principal SponsorUniversity Hospital, Antwerp
Last updated: February 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease AttributesCritical Illness

Criteria

4 inclusion criteria required to participate
APACHE II (Acute Physiology and Chronic Health Evaluation II) score >= 20
Patients admitted to a medical intensive care unit
age: >= 18 y , < 75 y
expected length of stay in ICU > 3 days
4 exclusion criteria prevent from participating
no informed consent
patient with a DNR (do not reanimate) code
pregnancy
surgical patient

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Group II

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Middelheim General Hospital

Antwerp, BelgiumOpen Middelheim General Hospital in Google Maps

Antwerp University Hospital

Edegem, Belgium
Completed2 Study Centers