Impact of Functional Insulinotherapy on Blood Glucose Variability Indicators in Patients With Type 1 Diabetes (VARIAFIT)
The primary objective of this trial is to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.
So, this study measures the impact of functional insulinotherapy on several blood glucose variability indicators in patients with type 1 diabetes.
This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress and inflammation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a prospective, open, non-controlled study with an individual benefit for the participant. This study is designed to assess whether functional insulinotherapy decreases blood glucose variability at 3 months and 6 months, compared to initial values in type 1 diabetes patients.
All 30 patients with type 1 diabetes attended a 4-day functional insulinotherapy class, taught by 2 nurses, 2 dieticians and 2 physicians. The participants were recruited among metabolically stable patients who had already been prescribed functional insulinotherapy.
To assess the impact of functional insulinotherapy on blood glucose variability, HbA1c will be measured at 0, 3 months and 6 months along with 4 blood glucose variability indicators: MAGE, ADRR, LI and LBGI.
This trial also has a secondary objective: to measure the effect of functional insulinotherapy on oxidative stress. Therefore, a measure of insulin antibodies by ELISA at baseline. At baseline and 6 months, LTE4, TXB2, 8-iso-PGF2alpha, anti-transglutaminase and anti-endomysium antibodies will also be assessed.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Grenoble Cedex 9, Francia, 38043
- Service de Diabétologie du Pr Halimi, CHU
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Patients with type 1 diabetes with pump or multi-injection treatment and attending a functional insulinotherapy class
- Social Security membership or benefit from Social Security
- Informed consent, with a signed and approved form
Exclusion Criteria:
- Underage patient, major patient under guardianship or protected by the Law
- Pregnant, parturient or breastfeeding woman
- Person with no freedom (prisoner), person in an emergency situation, person hospitalized without consent and not protected by the Law
- Antecedents of pathologies causing diabetes instability (coeliac disease, gastroparesis, non-balanced psychiatric pathology) and not optimally treated, acute pathology less than 3 months ago (infectious, cardio-vascular, metabolic), pregnancy
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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patients with functional insulinotherapy
There is only one group in this study.
The participants will attend a functional insulinotherapy class.
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The functional insulinotherapy class lasts for 4 days. It is taught by 2 nurses, 2 dieticians and 2 physicians to 6 to 10 patients. On day 1, patients describe their difficulties with diabetes. Fast-acting insulin scales are elaborated from preprandial and postprandial blood glucose levels. At dinner, patients start a 24-hour glucose-fasting period to evaluate their need for basal insulin. Meals contain virtually no carbohydrates. Correcting doses of insulin are administered if preprandial glycemia is over 1.50 g/l or postprandial glycemia is over 2 g/l. Blood glucose levels must stay within normal values during the whole 24-hour period. Carbohydrate management is taught during meals and every afternoon through workshops about dietetics. Patients also learn how to deal with hypoglycaemia, hyperglycaemia and physical activity. A one-day follow-up takes place 3 months later. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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MAGE, ADRR, Lability Index and LBGI computed with the blood glucose measurement or CGMS
Periodo de tiempo: 0, 3 months, 6 months
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0, 3 months, 6 months
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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anti-transglutaminase and anti-endomysium antibodies
Periodo de tiempo: 0 months, 6 months
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0 months, 6 months
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dosage of urinary leucotriene E4 and 11-dehydro-thromboxane B2, 8-iso-PGF2alpha
Periodo de tiempo: 0 months, 6 months
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0 months, 6 months
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anti-insulin antibodies by ELISA
Periodo de tiempo: 0 months
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0 months
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Colaboradores e Investigadores
Investigadores
- Investigador principal: Pierre-Yves Benhamou, PhD, University Hospital, Grenoble
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Otros números de identificación del estudio
- 2007-A00903-50
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