Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

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

26 de abril de 2026 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

201

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Glycemic control after hospitalization for COVID-19
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in HbA1c over follow-up
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

28 de janeiro de 2021

Conclusão Primária (Real)

24 de agosto de 2022

Conclusão do estudo (Real)

24 de agosto de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

26 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de abril de 2026

Primeira postagem (Real)

30 de abril de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de abril de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever