Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Effects of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients (GlucoClearIT)

9 marzo 2017 aggiornato da: Erasme University Hospital

A Study on the Effects of the Use of GlucoClear CGM System on the Performance of Insulin Therapy in Critically Ill Patients

After providing written informed consent, the first 20 Subjects meeting Inclusion/Exclusion Criteria will be consecutively enrolled in the Standard of Care cohort. The moderate treatment cohort will then be consecutively enrolled, followed by the tight glycemic control cohort.

After sensor insertion, baseline evaluations including APACHE II, SOFA, and laboratory evaluations will be determined.

Subjects enrolled in the standard of care cohort will be treated according to the institution's protocol for measuring glucose and managing insulin. These subjects will be monitored on a GlucoClear System but they will not be managed based on the values or trends of the GlucoClear system.

Subjects enrolled in the treatment cohorts will be monitored and managed with a special version of the GlucoClear continuous monitoring system. This system contains the GlucoClear Insulin Dosing Algorithm providing insulin dosing recommendations to enable the clinician to manage patient glucose within pre-specified target levels. These recommendations are presented on screen for a clinical professional to approve or override.

Subjects in the moderate treatment cohort will have their glucose managed in the range of 120 - 180 mg/dl. Subjects in the tight glycemic control treatment cohort will be managed in the range of 80 - 120 mg/dl.

After discharge from the ICU, subjects will followed for adverse events and mortality at 30 days, either by telephone contact or office visit.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Hyperglycemia, hypoglycemia and glycemic variability, the three components of dysglycemia are independently associated with morbidity and mortality of critically ill patients. Blood glucose (BG) control with insulin has the potential to decrease morbidity and mortality of intensive care unit (ICU) patients. Blood glucose control with insulin, however, is associated with an increased risk of hypoglycemia and its effect on glycemic variability is uncertain. BG control with insulin utilizing manual systems for glucose measurement is blood-consuming and time-consuming, since frequent blood draws for glucose measurements are necessary in order to achieve blood glucose control.

Severe hypoglycemia (blood glucose level < 40 mg/dl) is a feared complication of blood glucose control with insulin. Undoubtedly, with implementation of blood glucose with insulin the incidence of hypoglycemia increases. Reported incidences of severe hypoglycemia rise by 5 to 10-fold as compared to conventional glucose control strategies in randomized controlled trials. Several reports showed a significant association between hypoglycemia and patient outcomes. Recently, an association has even been suggested between moderate and mild hypoglycemia (blood glucose level between 40-69 mg/dL) and patient outcomes. Incidences of moderate hypoglycemia are more prevalent than severe hypoglycemia. The risk of developing (severe or moderate) hypoglycemia hampers, at least in part, broad implementation of blood glucose control with insulin, in particular when aiming at normal blood glucose levels [17,18].

Recent studies showed also significant associations between glycemic variability and patient outcomes. BG control algorithms, if properly applied, could decrease glycemic variability. Experimentally, rodent experiment showed that brain damage was not associated with the duration of severe hypoglycemia, but instead with its correction (mainly overcorrection) with intravenous dextrose causing formation of radicals. Hence, a close glucose monitoring to prevent overcorrection is mandatory.

These different arguments strongly support the need for reliable and accurate CGM. The GlucoClearTM Continuous Glucose Monitoring system from Edwards Lifesciences measures blood sugar by Glucose Oxidase Sensing Technology through in-blood measurement. Blood is automatically drawn and analyzed every 5 minutes from a peripheral venous catheter, with real time graphical display. Blood is then returned to the patient and the system automatically self-calibrates. The GlucoClear CGM is designed to be highly accurate. In a recent study performed in critically ill patients, it was shown to comply with the required standards of quality.

The main research question addressed by the present study is: "To which extent a CGM-guided strategy improve the quality of BG control performance"?

Tipo di studio

Interventistico

Iscrizione (Effettivo)

100

Fase

  • Non applicabile

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Have an anticipated ICU stay of at least 48 hours;
  • Participate or have authorized representative participate in the Informed Consent process and sign/date the approved informed consent form.
  • Have an expected ICU stay of ≥ 24 hours up to 72 hours
  • Have an APACHE II score of ≥ 10, within the first 24 hours of ICU admission.
  • Not be participating in any other investigational interventional study.
  • Have hyperglycemia (BG > 150 mg/dl) up to 6 hours after admission and / or ongoing insulin therapy.
  • Access to a large peripheral vein

Exclusion Criteria:

  • End stage pre-existing medical conditions that would preclude the subject from being able to complete up to 72 hours of glucose monitoring and follow up (14 ± 3 days after Sensor removal); Restricted peripheral venous access, inadequate access for reference sampling or any contraindication to the placement of peripheral IV catheters.
  • Skin conditions or existing (or planned) medical instrumentation and/or dressings that preclude placing the peripheral IV catheters or dressings (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis, or surgical dressings).
  • A known history of heparin-induced thrombocytopenia or any contraindication for anti-coagulation therapy.
  • Intolerance to Lactated Ringer's solution ((mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 110; Lactate 28).
  • A positive pregnancy test 72 hours prior to Sensor insertion (for subjects of child bearing potential).
  • Any condition that, in the opinion of the Investigator, would interfere with their participation in the Study.
  • Participated in any other drug, device, or biologic Study within the last 30 days (prior to Sensor insertion) which may clinically interfere with this Study or have not completed the required Protocol follow-up period.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Continuous monitoring-guided therapy
Healthcare providers were allowed to use the blood glucose values displayed on the intravascular continuous monitoring to adapt insulin therapy
Dispositivo: Intravascular continuous monitoring
Bedside usual insulin therapy guided by continuous glucose monitoring
Altro: Standard of care
Healthcare providers used the usual intermittent method to adapt insulin therapy; the blood glucose values measured by the intravascular continuous monitoring were not displayed but recorded. Usual care involves the adjustment of insulin infusion based on BG values measured with a blood gas analyser 4-6 times per day.
Altro: Standard of care
Bedside usual insulin therapy guided by intemittent glucose monitoring

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time in target
Lasso di tempo: 72 hours
Cumulative time in target band (expressed in percentage) will be calculated from the set of BG values recorded by the CGM in both groups.
72 hours

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Punteggio SOFA
Lasso di tempo: 72 ore
72 ore
Hypoglycaemic index
Lasso di tempo: 72 hours
Area under the low limit of the target range
72 hours
Glycemic variability
Lasso di tempo: 72 hours
Coefficient of variation
72 hours
Mortality
Lasso di tempo: 28 days
ICU, hospital and 28-day mortality
28 days
Length of stay
Lasso di tempo: 28 days
28 days
Time to target
Lasso di tempo: 72 hours
Time to achieve the upper limit of target range (hours)
72 hours

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Erasme University Hospital

Collaboratori

Edwards Lifesciences

Investigatori

  • Direttore dello studio: Jean-Louis Vincent, MD PhD, Erasme University Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 maggio 2014

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

1 giugno 2015

Date di iscrizione allo studio

Primo inviato

3 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

8 febbraio 2017

Primo Inserito (Stima)

9 febbraio 2017

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 marzo 2017

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 marzo 2017

Ultimo verificato

1 febbraio 2017

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • P2014/162 / B406201420742

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Iperglicemia da stress metabolico

Prove cliniche su Intravascular continuous monitoring

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in United Kingdom

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi