Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients (COVIGLYSTRESS)
Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
Descripción general del estudio
Estado
Condiciones
Descripción detallada
The rapid spread of the COVID-19 pandemic and the isolation at home implemented in France, creates unprecedented challenges for diabetic patients.
Patients with diabetes have been considered to be at higher risk of infection by the virus, with a greater risk of mortality; this has been a great source of anxiety for them.
It is well known that stress has an impact on plasma glucose levels. The French situation where a general confinement has been decreed over the whole territory (which is not the case for all countries) and for a period of two months, makes it possible to study the impact of this unique situation on stress, sedentary lifestyle, changes in diet and decrease in physical activity. There are no similar experiences described in the literature.
The investigators hypothesize there will be an increase of HbA1c in the coming months.
The main objective is to assess changes in glycemic control in diabetic patients after the confinement period.
The secondary objectives are to:
- Evaluate the prevalence of a state of psychological distress (which could be described as post-traumatic) following this epidemic situation in a population of patients with diabetes and to determine the main characteristics of patients with such a state of psychological distress.
- Study the evolution of the psychological state at a distance from confinement (6 months later) with the same questionnaire.
- Analyze characteristics of lifestyle during confinement: food (snacking), frequency of leaving home, sleep disorders and assess a possible association with variations in HbA1c.
This is an observational, prospective, multicenter study. Participation in the study will be offered to all consecutive patients seen in Diabetes consultations, who meet the selection criteria.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Brest, Francia, 29000
- Brest University Hospital
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Dijon, Francia, 21000
- CHU de Dijon
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Grenoble, Francia
- CHU Grenoble
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Lyon, Francia
- Hospices Civils Lyon
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Mulhouse, Francia
- GHRMSA
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Rouen, Francia
- CHU Rouen Hôpital Boisguillaume
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Saint-Malo, Francia
- CH de Saint Malo
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Tours, Francia, 37170
- CHRU de Tours
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Vannes, Francia
- Bretagne Atlantique Hospital
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Bretagne
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Rennes, Bretagne, Francia, 35033
- Rennes University Hospital
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Centre-Val De Loire
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Montargis, Centre-Val De Loire, Francia, 45207
- Centre Hospitalier de l'Agglomération Montargoise
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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:
- Adult patient (≥ 18 years old)
- Diabetic patient (type 1 or type 2) regardless of their diabetes treatment who experienced complete confinement in their own home, in France.
- Patients who had a measured HbA1 or an estimated HbA1c with a glucose sensor Freestyle libre with a known result, between November 1, 2019 and February 29, 2020.
- Patients agreeing to have their HbA1c measured between May 15 and July 31, 2020.
- Having been informed of the study and not objecting to participating in it
Exclusion Criteria:
- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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HbA1c
Periodo de tiempo: Baseline
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The change in HbA1c over the first confinement period as compared to the value in early 2020.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Stress
Periodo de tiempo: Baseline
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The level of stress as assessed by the GHQ questionnaire and the prevalence of a state of psychological distress (defined by a Likert index in the GHQ test 12 ≥14) both evaluated after the first confinement period in France and then 6 months later, in this population of diabetic patients.
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Baseline
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Fabrice BONNET, Rennes University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 35RC20_9780_COVIGLYSTRESS
Información sobre medicamentos y dispositivos, documentos del estudio
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