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Glucose Clamp Study to Prove Hypo- and Hyperglycemic Episodes Using a Non-invasive Glucose Monitoring Device Fase I, Fase II 21 No invasivo

Completado
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT01060917 tuvo como objetivo estudiar el tratamiento de Diabetes mellitus. Este fue un estudio intervencionista de Fase I Fase II. Su estado actual es: completado. El estudio se inició el 1 de enero de 2003, con el objetivo de reclutar a 21 participantes. Dirigido por Profil Institut für Stoffwechselforschung GmbH, la fecha de finalización prevista fue el 1 de mayo de 2003. Los datos se actualizaron por última vez en ClinicalTrials.gov el 2 de febrero de 2010.
Resumen
Continuous monitoring of the skin tissue glucose concentration on two different study days using glucose sensors that work on the principle of impedance spectroscopy, with systematic alteration of the blood glucose concentration using the glucose clamp technique in healthy subjects and subjects with type 1 diabetes. Simultaneous determination of electrolyte concentrations in the blood by taking frequent blood samples...Mostrar más
Descripción detallada
A completely non-invasive continuous glucose monitoring device is considered as a major target of glucose sensor development. The aim of this study is to evaluate the performance of a non-invasive glucose sensor (wristwatch) under controlled conditions (glucose clamp) at hyperglycemia (study day 1) and at hypoglycemia (study day 2). Measurements of the non-invasive glucose monitoring device are compared to those obta...Mostrar más
Título oficial

A Single Center, Open Study in Order to Prove Hypo- and Hyperglycaemic Episodes Using a Non-invasive Glucose Measuring Method in Healthy Volunteers and in Type 1 Diabetic Patients

Condiciones médicas
Diabetes mellitus
Publicaciones
Artículos científicos y trabajos de investigación publicados sobre este estudio clínico:
Otros ID del estudio
  • 06/0097-Study 4
Número del NCT
NCT01060917
Inicio del estudio (real)
2003-01
Última actualización
2010-02-02
Fecha de finalización (estimada)
2003-05
Inscripción (prevista)
21
Tipo de estudio
Intervencionista
FASE
Fase I
Fase II
Estado general
Completado
Palabras clave
diabetes
Objetivo principal
Tratamiento
Método de asignación
No aleatorizado
Modelo de intervención
Grupo único
Enmascaramiento
Ninguno (Abierto)
Brazos / Intervenciones
Grupo de participantesIntervención/Tratamiento
N/A
Non-invasive CGMS (continuous glucose monitoring system)
A non-invasive continuous glucose monitoring device measure was applied at the wrist and measure skin glucose as an indirect measure of blood glucose every 10 min.
Hyperglycemic and hypoglycemic glucose clamp
The automated glucose clamp technique was used to control glucose levels at baseline glycemia for 1h, hyperglycemia (300 mg/dL) for 1.5 h, and euglycemia (100 mg/dL) for another 1.5 h. A continuous somatostatin infusion was initiated after the 2 h run-in period to suppress endogenous insulin secretion. A glucose solution was infused to increase blood glucose towards the hyperglycemic target level. At the end of the h...Mostrar más
Non-invasive CGMS (GlucoDay)
The minimally-invasive glucose sensor GlucoDay, was used as a control measure
Resultado primario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
skin tissue glucose concentration
continuously during the glucose clamp
Resultado secundario
Medida de resultadoDescripción de la medidaPeriodo de tiempo
serum and urine electrolyte concentrations (sodium, potassium, chloride, calcium, magnesium, urea, osmolarity, pH, lactate, p(O2), standard bicarbonate, p(CO2), blood glucose concentration
at 5 min intervals between the individual plateau phases, at 10 min intervals during the plateau phases (of the blood glucose concentration)
Criterios de elegibilidad

Criterios de edad
Adulto
Edad mínima
18 Years
Criterios de sexo
Todos
Admisión de voluntarios sanos
Sí

Healthy male and female volunteers:

  • Written informed consent
  • Aged between 18 and 40 years
  • Body mass index between 18 and 28 kg/m²
  • Haemoglobin > 13 g%

Male and female patients with type 1 diabetes:

  • Known type 1 diabetes, first manifestation 6 months to 15 years before the start of the study
  • HbA1c <= 9%
  • Written informed consent
  • Aged between 18 and 40 years
  • Body mass index between 18 and 28 kg/m²
  • Haemoglobin > 13 g%

  • Uncontrolled arterial hypertension (diastolic blood pressure >100 mmHg and/or systolic blood pressure > 180 mmHg)
  • For women, pregnancy or breast-feeding or, for sexually active women of child-bearing age, the use of contraceptive methods considered to be safe (oral contraceptives, IUD, implanted or injected contraceptives, diaphragms, or surgical sterilisation of the patient or her partner)
  • Deviations in the lab values (excluding HbA1c), as judged by the investigator to be clinically significant, in particular an increase in transaminases to a level that is two and a half times higher than the upper normal value and a creatinine value that is above the normal range
  • Severe acute diseases, as judged by the investigator
  • Severe chronic disease, as judged by the investigator
  • History of macrovascular illnesses such as pAVK, myocardial infarction
  • Known microvascular (diabetic) complications (other than diabetic background retinopathy)
  • Positive serology for hepatitis B, hepatitis C or HIV
  • Blood donation within 3 months prior to the start of the study and intention of donating blood within 3 months after the end of the study
Profil Institut für Stoffwechselforschung GmbH logoProfil Institut für Stoffwechselforschung GmbH
Pendragon Medical AG Switzerland logoPendragon Medical AG Switzerland
No hay datos de contacto.
1 Centros del estudio en 1 países
Profil Institut für Stoffwechselforschung GmbH, Neuss, 41460, Germany