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Acute Metabolic Outcomes in Diabetic Patients Hospitalized for COVID-19 (DMD-COV) (DMD-COV)

26 de abril de 2026 actualizado por: Algerian Society of Diabetology

Acute Metabolic Outcomes of Diabetic Patients Hospitalized for COVID-19 in Algeria: A Prospective Cohort Study (DMD-COV)

Diabetes is a major risk factor for severe COVID-19 and poor clinical outcomes during hospitalization. However, little is known about the medium- and long-term metabolic consequences of COVID-19 in people with diabetes after hospital discharge.

The DMD-COV study is a prospective, multicenter observational cohort conducted in Algeria. Its aim is to evaluate the cardio-metabolic outcomes of adult patients with diabetes who were hospitalized for confirmed COVID-19 and survived the acute phase of the infection.

Adult patients with type 1 or type 2 diabetes will be included during hospitalization or within 30 days after hospital discharge. Participants will be followed for up to one year after discharge, with scheduled evaluations at baseline, 3 months, 6 months, and 12 months.

During follow-up, clinical, biological, and therapeutic data will be collected, including glycemic control (HbA1c), body weight, lipid profile, kidney function, and diabetes treatments. The main outcome is the proportion of patients achieving their individualized HbA1c target at 6 months and 12 months after hospitalization for COVID-19.

The results of this study will help to better understand the long-term metabolic impact of COVID-19 in people with diabetes and to improve post-COVID diabetes management.

Descripción general del estudio

Descripción detallada

The DMD-COV study is a prospective, non-interventional, multicenter cohort study conducted in Algeria. The study aims to describe the cardio-metabolic outcomes of adult patients with diabetes following hospitalization for COVID-19.

Patients with type 1 or type 2 diabetes who were hospitalized for laboratory-confirmed COVID-19 (PCR, serology, or antigen test) will be included during hospitalization or within 30 days after discharge. The study does not interfere with routine clinical care, and all therapeutic decisions are made according to usual medical practice.

Approximately 200 patients will be enrolled across multiple university hospital centers. Participants will be followed for one year, with four scheduled visits: at baseline (inclusion), 3 months, 6 months, and 12 months after hospital discharge.

Data collected during the study include demographic characteristics, diabetes history, comorbidities, COVID-19 severity markers, duration of hospitalization, and treatments received during the acute phase, including corticosteroids and anticoagulants. At each follow-up visit, clinical parameters (weight, body mass index, waist circumference), glycemic control (HbA1c, fasting plasma glucose), lipid profile, renal function, and diabetes treatments will be recorded.

The primary outcome is glycemic control, assessed by the proportion of patients achieving their individualized HbA1c target at 6 months and 12 months after hospitalization. Secondary outcomes include changes in HbA1c over time, evolution of diabetes treatments, weight changes, lipid profile, renal function, and identification of factors associated with good glycemic control after COVID-19.

This study will provide valuable real-world data on the metabolic evolution of patients with diabetes after COVID-19 and may contribute to optimizing long-term follow-up strategies in this population.

Tipo de estudio

De observación

Inscripción (Actual)

201

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • El Biar
      • Algiers, El Biar, Argelia
        • Djillali Belkhenchir Public Hospital (formerly Birtraria)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

Adult patients with type 1 or type 2 diabetes who were hospitalized for confirmed COVID-19 and followed after hospital discharge to assess cardio-metabolic outcomes.

Descripción

Inclusion Criteria:

  • Age 18 years or older
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Hospitalization for laboratory-confirmed COVID-19
  • Inclusion during hospitalization or within 30 days after hospital discharge
  • Signed informed consent

Exclusion Criteria:

  • Age under 18 years
  • Absence of diabetes mellitus
  • Refusal or inability to provide informed consent

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
Diabetic patients hospitalized for COVID-19
Adult patients with type 1 or type 2 diabetes who were hospitalized for confirmed COVID-19 and followed prospectively after hospital discharge to assess cardio-metabolic outcomes over a one-year period.
This is a non-interventional observational study. No experimental or therapeutic intervention is assigned as part of the study protocol. All medical care and treatments are provided according to routine clinical practice.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Glycemic control after hospitalization for COVID-19
Periodo de tiempo: 6 months and 12 months after hospital discharge
Proportion of patients achieving their individualized HbA1c target according to international diabetes guidelines.
6 months and 12 months after hospital discharge

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in HbA1c over follow-up
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
Mean change in HbA1c from baseline to 3 months, 6 months, and 12 months after hospital discharge.
Baseline, 3 months, 6 months, and 12 months
Change in body weight and body mass index
Periodo de tiempo: Baseline, 3 months, 6 months, and 12 months
Change in body weight and body mass index (BMI) during follow-up.
Baseline, 3 months, 6 months, and 12 months
Evolution of diabetes treatment
Periodo de tiempo: Up to 12 months after hospital discharge
Changes in diabetes treatment regimen during follow-up, including insulin initiation or intensification and modification of oral or injectable antidiabetic therapies.
Up to 12 months after hospital discharge
Changes in lipid profile and renal function
Periodo de tiempo: Baseline, 6 months, and 12 months
Changes in lipid profile parameters and renal function during follow-up after COVID-19 hospitalization.
Baseline, 6 months, and 12 months
Factors associated with poor glycemic control after COVID-19
Periodo de tiempo: Up to 12 months after hospital discharge
Identification of clinical and therapeutic factors associated with failure to achieve individualized HbA1c targets after hospitalization for COVID-19.
Up to 12 months after hospital discharge

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de enero de 2021

Finalización primaria (Actual)

24 de agosto de 2022

Finalización del estudio (Actual)

24 de agosto de 2022

Fechas de registro del estudio

Enviado por primera vez

26 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

26 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de abril de 2026

Última verificación

1 de abril de 2026

Más información

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. .

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