Glucose Control in the ICU Using Continuous Glucose Monitoring

Study Overview
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Brief Summary
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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.

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

Conditions
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Critical Illness

Intervention / Treatment
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* Device: experimental: real-time continuous glucose monitoring
* Device: Active comparator: blinded continuous glucose monitoring


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: real-time continuous glucose monitoring<br>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<br> <br> * Other names: RT-CGM using the GlucoDay device (A. Menarini, Italy);|
| Active Comparator: blinded continuous glucose monitoring<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medical ICU patients, APACHE-II score ≥20