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Effect of Different Plasma Insulin Levels on the Accuracy of Continuous Subcutaneous Glucose Monitoring

24 octobre 2012 mis à jour par: Fundación para la Investigación del Hospital Clínico de Valencia

New Strategies for Automated Glycaemic Control: the Issue of Continuous Glucose Monitoring Accuracy Under Hypoglycaemic Conditions

Achieving near-normoglycaemia has been established as the main objective for most patients with diabetes. However, it is well known that intensification of treatment is associated with an increase in the frequency of hypoglycemia, especially in the context of insulin therapy. The burden of hypoglycemia in terms of psychological implications, morbidity and even mortality, explains why it has been defined as the main limiting factor to achievement of good metabolic control.

Continuous subcutaneous glucose monitoring (CGM) devices have been claimed to be useful in hypoglycemia detection/prevention, allowing theoretically for safer intensification of therapy in diabetic patients. However, accuracy of CGM devices, especially in the hypoglycemic range, raises some concerns. In fact, commercially available CGM devices estimate plasma glucose from measurements in the interstitial fluid and not in plasma. However, the relationship between plasma and interstitial glucose is not fully understood, especially under dynamic conditions, and this may explain the poor CGM performance during rapid changes in blood glucose and hypoglycemia.

In this project, the relationship between plasma and interstitial glucose will be evaluated under conditions of normal glucose concentrations and hypoglycemia. Experiments will be performed to assess the role, if any, of different plasma insulin concentrations on the accuracy of CGM.

All the information obtained may be relevant to the improvement of the ability of CGM devices to detect hypoglycemia and hypoglycemic risk.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

14

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

  • Espagne
      • Valencia, Espagne, 46010
        • Servicio de Endocrinología y Nutrición, Hospital Clínico Universitario de Valencia

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 à 60 ans (Adulte)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • Subjects with type 1 diabetes mellitus meeting all of the following criteria will be considered for admission to the study:

    • Aged between 18 and 60 years
    • Under CSII or MDI treatment for at least six months before Visit 1
    • Body mass index of between 18 and 30 kg/m2
    • HbA1c 6.0-8.5% at Visit 1
    • Normal laboratory values, ECG, and vital signs unless the investigator considered an abnormality to be clinically irrelevant
    • Women postmenopausal or using contraception judged by the investigator to be adequate (e.g., oral contraceptives, intra-uterine device or surgical treatment)

Exclusion Criteria:

  • Subjects meeting any of the following criteria will not be included in the study:

    • Pregnancy and lactation
    • History of hypersensitivity to the study medications or to drugs with similar chemical structures
    • Confirmed hypoglycaemia unawareness
    • Progressive fatal diseases
    • History of drug or alcohol abuse
    • History of positive HIV or hepatitis B or C test
    • Impaired hepatic function, as shown by, but not limited to, SGPT or SGOT of more than twice the upper limit of the normal range at visit 1
    • Impaired renal function, as shown by, but not limited to, serum creatinine > 1.5 mg/dL at visit 1
    • Clinically relevant microvascular, cardiovascular, hepatic, neurologic, endocrine or other major systemic diseases other than T1DM which could hinder implementation of the clinical study protocol or interpretation of the study results
    • Pre-planned surgery during the study
    • Blood donation of more than 500 ml during the past three months for men, or during the past six months for women
    • Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
    • Subject unlikely to comply with clinical study protocol, e.g., uncooperative attitude, inability to return for follow-up visits, or poor likelihood of completing the study
    • Receipt of an experimental drug or use of an experimental device during the past 30 days.

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: Science basique
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation croisée
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: High plasma insulin-Low plasma insulin
Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a High insulin glucose clamp and on the second day a Low insulin glucose clamp (sequence 'AB')
Autre: High insulin eu-hypoglycemic clamp
Primed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
Autre: Low insulin eu-hypoglycemic clamp
Primed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
Autre: Low plasma insulin-High plasma insulin
Seven out of the 14 subjects recruited in the study have been randomized to receive on the first study day a Low insulin glucose clamp and on the second day a High insulin glucose clamp (sequence 'BA')
Autre: High insulin eu-hypoglycemic clamp
Primed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
Autre: Low insulin eu-hypoglycemic clamp
Primed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Normalized current signal from the CGM devices
Délai: 330 minutes

CGM devices are electrochemical sensors. Currently available sensors are placed in the subcutaneous tissue where they react with the glucose of the interstitial fluid giving a current signal (in nano Amperes), which is proportional to glucose concentrations. The current signal is then filtered and transformed into plasma glucose estimations through a calibration algorithm built into the CGM device.

In this study we will analyze the current signal from CGM obtained under two different experimental conditions:

  1. Eu-hypoglycemic clamp with High plasma insulin concentrations
  2. Eu-hypoglycemic clamp with relatively Low plasma insulin concentrations

This will allow for establishing the role, if any, of different plasma insulin concentrations on the accuracy of CGM to identify plasma glucose falls resulting in hypoglycaemia.

Since CGM sensors can exhibit different sensitivities to glucose concentrations, the current signal will be normalized before statistical analysis
330 minutes

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Fundación para la Investigación del Hospital Clínico de Valencia

Collaborateurs

Universitat Politècnica de València

Les enquêteurs

  • Chercheur principal: Francisco Javier Ampudia-Blasco, MD, PhD, Hospital Clínico Universitario de Valencia - Fundación INCLIVA

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

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 octobre 2011

Achèvement primaire (Réel)

1 septembre 2012

Achèvement de l'étude (Réel)

1 octobre 2012

Dates d'inscription aux études

Première soumission

24 octobre 2012

Première soumission répondant aux critères de contrôle qualité

24 octobre 2012

Première publication (Estimation)

26 octobre 2012

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

26 octobre 2012

Dernière mise à jour soumise répondant aux critères de contrôle qualité

24 octobre 2012

Dernière vérification

1 octobre 2012

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • FP7-PEOPLE-2009-IEF #252085-2
  • Spanish Ministry of Science (Autre subvention/numéro de financement: spanish Ministry of Science, DPI2010-20764-C02-01)

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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