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

2026年4月26日 更新者: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.

研究概览

详细说明

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.

研究类型

观察性的

注册 (实际的)

201

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • El Biar
      • Algiers、El Biar、阿尔及利亚
        • Djillali Belkhenchir Public Hospital (formerly Birtraria)

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

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.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Glycemic control after hospitalization for COVID-19
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Change in HbA1c over follow-up
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年1月28日

初级完成 (实际的)

2022年8月24日

研究完成 (实际的)

2022年8月24日

研究注册日期

首次提交

2026年4月26日

首先提交符合 QC 标准的

2026年4月26日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月26日

最后验证

2026年4月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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