Diabetes In Relation to Hospitalized COVID-19 Patents At Assiut University Hospital

Study Overview
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Brief Summary
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Coronavirus disease (COVID-19), a global pandemic affecting the whole world and taking the lives of millions. The majority of fatalities occur in the elderly specially in the presence of chronic diseases such as diabetes mellitus (DM), hypertension, obesity, cardiovascular disease, chronic kidney disease and cancer.

Detailed Description
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Knowing about the family of coronaviruses is that they are the cause of a variety of well-known diseases affecting humans, ranging from common cold to the Middle East Respiratory Syndrome (MERS) and Acute Severe Respiratory Syndrome (SARS), and now the COVID-19 as a new problematic family member. Regarding DM as a knowing old health problem, it has been found that we can use it in predicting the prognosis of the COVID-19 as admission to intensive care unit, invasive ventilation or even death. Previous studies confirmed that uncontrolled DM can badly affects innate immunity which considered as the first line of defence mechanism against COVID-19 infection. In addition, DM has a pro-inflammatory effect through exaggeration of cytokine response which appears clearly through higher results of serum levels of interleukin-6 (IL-6), C-reactive protein and ferritin, this suggests that people with DM are more venerable to cytokine storm which leads to Acute Respiratory Distress Syndrome (ARDS), shock and rapid deterioration of the case. On the other hand, on looking to previous studies and data collected about the prior SARS outbreak in 2003, which suggested that COVID-19 can lead to worsening of glycemic control in known diabetic patients and above that caused by the stressful nature of a critical illness. In addition, COVID-19 can lead to increasing insulin resistance specially in patients with type II DM. Also, the medications used in the management of COVID-19 having an indirect role on worsening of blood sugar levels also should be taken in our consideration, Corticosteroids as an example, used in the management of patients having ARDS or sepsis can lead to changes in their glycemic profile.

Official Title
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Outcomes of Diabetes In Hospitalized COVID-19 Patients At Assiut University Hospital

Conditions
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Diabetes Mellitus, COVID-19

Intervention / Treatment
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* Diagnostic Test: Reverse transcription polymerase chain reaction (RT-PCR)
* Diagnostic Test: Glycated haemoglobin (HbA1C)
* Radiation: High Resolution Computed Tomography (HRCT)
* Diagnostic Test: Routine Laboratory investigations
* Diagnostic Test: Random Blood Sugar (RBS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cases aged 18 years and over. Cases diagnosed as COVID-19 positive. Cases admitted to Assiut University Hospitals. Exclusion Criteria: Age less than 18 years. Outpatient management (even in confirmed cases of COVID-19).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19 with DM<br>All patients will be screened for diabetes according to history and blood glucose measurements as well as HbA1C. Accordingly, the patients will be divided into two groups, diabetic and non-diabetic group. | Diagnostic Test: Reverse transcription polymerase chain reaction (RT-PCR)<br>* For SARS Corona Virus 2 (COV2) confirmation<br>* Other names: Reverse transcription polymerase chain reaction;Diagnostic Test: Glycated haemoglobin (HbA1C)<br>* Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control<br>* Other names: Glycated haemoglobin;Radiation: High Resolution Computed Tomography (HRCT)<br>* with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation<br>* Other names: High Resolution Computed Tomography;Diagnostic Test: Routine Laboratory investigations<br>* Arterial blood gases (ABGs) Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)<br>Diagnostic Test: Random Blood Sugar (RBS)<br>* Blood Sugar will be measured before each meal and before bed time during hospitalization.<br>|
| COVID-19 without DM<br>All patients will be screened for diabetes according to history and blood glucose measurements as well as HbA1C. Accordingly, the patients will be divided into two groups, diabetic and non-diabetic group. | Diagnostic Test: Reverse transcription polymerase chain reaction (RT-PCR)<br>* For SARS Corona Virus 2 (COV2) confirmation<br>* Other names: Reverse transcription polymerase chain reaction;Diagnostic Test: Glycated haemoglobin (HbA1C)<br>* Diabetic patients' group will be categorized according to their glycemic control by using their glycated haemoglobin (HBA1C) into good control, fair control and poor control<br>* Other names: Glycated haemoglobin;Radiation: High Resolution Computed Tomography (HRCT)<br>* with the coronavirus disease 2019 Reporting and Data System (CO-RADS) classification grade 5 for SARS COV2 confirmation<br>* Other names: High Resolution Computed Tomography;Diagnostic Test: Routine Laboratory investigations<br>* Arterial blood gases (ABGs) Routine Laboratory investigations (Urea, Creatinine, Liver function tests, Serum Electrolytes, Prothrombin Concentration)<br>Diagnostic Test: Random Blood Sugar (RBS)<br>* Blood Sugar will be measured before each meal and before bed time during hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rates | mortality rate among diabetic and non diabetic COVID-19 patients | up to 1 year | 
| Hospital stays | for how long patients admitted to hospital | up to 1 year | 
| Need for ICU admission | who will need ICU admission during patient hospitalization | up to 1 year | 
| Need for ventilatory support | who will need for ventilatory support (Non-Invasive ventilation (NIV), High Flow Nasal Cannula (HFNC) and Invasive Mechanical Ventilation (IMV). | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | monitoring of glycemic control among patient groups | up to 1 year | 
| Newly onset DM will appear among non-diabetic patients | who will develop DM among non-diabetic group | up to 1 year | 
| Acute complications of diabetes | as hypoglycaemia, diabetic ketoacidosis and hyperosmolar nonketotic coma | up to 1 year | 
| Exacerbation of chronic complications of diabetes | as diabetic retinopathy, nephropathy and neuropathy | up to 1 year | 
| Changes of diabetes management plan | who will be shifted from oral to insulin therapy and who will be changed of their insulin regimen or introduction form from subcutaneous to intravenous infusion | up to 1 year | 
| Incidence of other complications | as hypertension renal and liver diseases | up to 1 year |