Use of an Insulin Infusion Conversion Equation (IICE) to Control Blood Glucose in Hospitalized Patients (IICE)
12 septembre 2014 mis à jour par: G. Randy Smith, Jr., M.D., Emory University
Use of an Insulin Infusion Conversion Equation (IICE) to Improve Inpatient Glycemic Control: A Randomized Controlled Trial
Insulin infusions are commonly used in hospitalized diabetics to control blood sugar, and they are effective.
However, insulin infusions require the use of limited resources.
Insulin infusions are therefore changed to insulin shots as a patient recovers.
Once an insulin infusion is stopped and shots are started, blood sugar control is harder to maintain.
This is, in part, because physicians have different ideas on how to dose insulin shots in hospitalized patients.
A math equation has been developed by the research staff that attempts to predict the effective doses of insulin shots in patients whose insulin infusion have just been stopped.
The math equation was developed for patients with type 2 diabetes mellitus.
In this study, all patients will be treated with the same type of insulin shots, with doses of the insulin shots chosen either by the math equation or by the judgment of the patient's physician.
The study will then follow blood sugar values for 24 hours to see if the math equation is effective.
If the equation is proven to be effective, a new tool will exist for physicians to determine the best dose of insulin shots for type 2 diabetics.
Such a tool would, in turn, allow for widespread use of insulin infusions to determine a patient's insulin needs before discharge from the hospital.
Blood sugar control for type 2 diabetics that are inpatient or outpatient would improve as a result, with potentially far reaching public health benefits.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
78
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Emory Crawford Long Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Inpatients at an urban, mixed academic and community tertiary care hospital who were on IV insulin were enrolled.
- Patients were taken from medical, general surgical, and cardiothoracic services, and were located both inside and outside the intensive care unit (ICU).
Exclusion Criteria:
- At time of enrollment, patients with type I diabetes mellitus,
- active acute or chronic pancreatitis,
- history of pancreatic surgery,
- use of a self-titratable insulin pump, or
- history of β-islet cell transplantation were excluded.
- At time of randomization, patients with insulin drip rates ≤ 2 units/hr, ∆ in serum creatinine of > 20% in previous 24 hours, or
- those without caloric intake while on IV insulin were excluded.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Insulin infusion conversion equation
Insulin infusion conversion equation is used to determine subcutaneous insulin dosing for first 24 hours after cessation of an IV insulin infusion.
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Subcutaneous insulin was dosed according to an equation (too long for publication here) which gives the patient's 24 hour SC insulin requirement.
If patient was eating, 65% of equation result was given as insulin glargine SC qHS and 35% of equation result was divided evenly between three qAC doses of insulin aspart.
If patient was not eating, 100% of ISC was given as insulin glargine.
If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation.
Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]).
For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
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Comparateur actif: Control
Judgment of patient's healthcare provider is used to determine subcutaneous insulin dosing for first 24 hours after cessation of IV insulin infusion.
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Twenty-four hour subcutaneous insulin dosing requirement was determined according to the judgment of the patient's healthcare provider.
If patient was eating, insulin glargine SC qHS and three qAC doses of insulin aspart was given according to the judgment of the patients's healthcare provider.
If patient was not eating, 100% of insulin was given as insulin glargine.
If IV insulin was stopped between 7 AM and 3 PM, 1/2 to 1/3 of scheduled insulin glargine dose was given as a one time insulin NPH SC dose at time of IV insulin cessation.
Correctional insulin was given as follows: For BG ≥ 150 mg/dL, (BG-100)/X units insulin aspart SC, X = 1500 / (scheduled glargine dose + [3 x scheduled aspart dose]).
For BG < 70 mg/dL, ½ ampule D50W IV x1 was given.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Percentage of Blood Glucose Values Within 80-140 mg/dL
Délai: Within 24 hours after cessation of IV insulin
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Fingerstick glucose measurements were obtained up to six times for each participant.
Percentage of blood glucose values within the target range of 80-140 mg/dL
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Within 24 hours after cessation of IV insulin
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Hypoglycemia (Serum Blood Glucose < 70 mg/dL)
Délai: Within 24 hours after cessation of IV insulin
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Within 24 hours after cessation of IV insulin
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Gregory R Smith, Jr., MD, Emory University
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 janvier 2008
Achèvement primaire (Réel)
1 mars 2009
Achèvement de l'étude (Réel)
1 mars 2009
Dates d'inscription aux études
Première soumission
25 mars 2008
Première soumission répondant aux critères de contrôle qualité
27 mars 2008
Première publication (Estimation)
28 mars 2008
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
15 septembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
12 septembre 2014
Dernière vérification
1 septembre 2014
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- IRB00006564
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