The InsuPad in Daily Life Study - Effect of Local Heating on Postprandial Glucose Excursions Using the InsuPad Device
A Randomised, Controlled, Cross-over Study With Inpatient and Outpatient Phases
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
A randomised, controlled, cross-over study with inpatient and outpatient phases. The inpatient phase length will be two days, which include a "Control" day without activating the InSuPad and a "Test" day where the InsuPad is activated. The outpatient phase length is 8 weeks: 4 weeks without the device-"Control", and 4 weeks with the device-"Test". Each subject will be randomly selected into one of two groups, group "A" and group "B". Forty (40) type I subjects who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
During the inpatient phase subjects will have standardized breakfast and dinner and venous blood samples will be taken for insulin and blood glucose measurements. Comparison of the two days ("control" and "test") will enable us to evaluate the effect of the device on post prandial glucose levels and insulin levels.
During the outpatient (daily life) phase subjects will be required to perform at least 5 self blood glucose measurements (SMBG), three before each meal and two at 90 minutes post breakfast and dinner. Comparing the SMBG measurement from the two periods will enable us to evaluate the effect of the device on post prandial glucose levels. The subjects will be contacted over the phone by the study staff to verify compliance with the protocol.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Bad Mergentheim, Alemania
- Bad Mergentheim
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Male or female patients aged 18 to 70 years (values included)
- Type 1 diabetes mellitus or insulin treated type 2 diabetes with daily insulin demand ≥ 0.7 units per kg bodyweight.
- 6% ≤ HbA1c ≤ 9.5%
- Use of short-acting prandial insulin analogues with injections
- Study subject is willing to perform at least 5 blood glucose measurements per day for at least 56 days, willing to comply with study procedures and to keep a detailed patient log book.
- Willing to sign informed consent
Exclusion Criteria:
- Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
- Known gastro- or enteroparesis.
- Unstable chronic disease other than type 1 diabetes (e.g. Unstable angina factoris, , renal disease) for the last six months before study start.
- Severe hypoglycemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
- Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire, see appendix)
- Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
- Any known life-threatening disease
- Pregnant women, lactating women or women who intend to become pregnant during the observation period
- Any other condition or compliance issues that might interfere with study participation or results
- Subjects with heat sensitivity
- Subjects involved in or planed to participate in other studies
- Subjects who are incapable of contracting or under guardianship
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: InsuPad Device
Use of the InsuPad which heats the injection site.
|
Heating pad
|
|
Sin intervención: CONTROL
no treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
efficacy
Periodo de tiempo: 2 hours
|
AUC120 BG (area under the curve of postprandial glucose change 2 hours after meal) after breakfast and dinner under standardized conditions during the inpatient phase.
|
2 hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Efficacy
Periodo de tiempo: 8 weeks
|
Mean change in post prandial glucose level at 90 minutes during the outpatient phase.
|
8 weeks
|
|
Efficacy
Periodo de tiempo: 8 weeks
|
AUC60 Ins (area under the curve of insulin concentration change 1 hour after meal) after breakfast and dinner under standardized conditions during the inpatient phase.
|
8 weeks
|
|
Safety
Periodo de tiempo: 14 weeks
|
• Number and severity of hypoglycaemias and hyperglycaemias and assessment of relationship to the use of the InsuPad device during the whole study.
|
14 weeks
|
|
Satisfaction
Periodo de tiempo: 14 weeks
|
• Patient satisfaction (subjective clinical performance) at the end of the study
|
14 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Trastornos del metabolismo de la glucosa
- Enfermedades metabólicas
- Enfermedades del Sistema Nervioso
- Enfermedades del sistema inmunológico
- Enfermedades autoinmunes
- Dolor
- Manifestaciones neurológicas
- Enfermedades del sistema endocrino
- Complicaciones de la diabetes
- Diabetes mellitus
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Diabetes Mellitus, Tipo 1
- Neuralgia
- Neuropatías diabéticas
Otros números de identificación del estudio
- CP-PP-002
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .