Glycaemia and Cardiac Function in Patients With COVID-19 (GLYCOVID-19)

Steno Diabetes Centers

Status: Completed

Conditions: Diabetes Mellitus, Type 1; COVID; Diabetes Mellitus; Diabetes Mellitus, Type 2

Treatments: Other: Glycaemic levels

Study type: Observational

Funder types: Other

Identifiers

NCT04410718

H-20024279

Details and patient eligibility

About

The study design is observational, exploratory study consisting of two cohorts of COVID-19 patients admitted to the ICU and the medical ward, respectively. The primary outcome focusing on the effect of plasma glucose levels on cardiac function will be evaluated by repeated assessment of cardiac function by echocardiography and measurement of plasma glucose. Furthermore, blood coagulability will be evaluated to determine the importance of diabetes status and plasma glucose changes for whole blood coagulability at time of admission to the ICU and progression in coagulability abnormalities. In the medical ward cohort, two assessments will be performed separated by no more than 12 hours. In the ICU cohort, three assessments will be performed separated by no more than 6 hours. Ideally, 60 patients with COVID-19 will be included in the ICU cohort with a 1:1 distribution between patient with and without diabetes. Ideally, 40 patients with diabetes will be included in the cohort of patients admitted to medical ward (hospitalisation cohort).

The primary hypothesis is that levels of plasma glucose have clinically significant impact on left ventricular systolic function in patients with COVID-19 admitted to the ICU. The secondary hypothesis is that the impact of plasma glucose on left ventricular systolic function is associated with glycaemic control prior to admission as measured by HbA1c.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The ICU cohort - Inclusion criteria

• Informed and written consent
• Age ≥18 years
• Verified COVID-19
• Admission to the ICU within the last 24 hours
• Type 1 or type 2 diabetes prior to admission (the diabetes sub-group only)

The ICU cohort - Exclusion criteria

• Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
• Pacemaker rhythm
• Severe valve disease

The hospitalisation cohort - inclusion criteria

• Informed and written consent
• Age ≥18 years
• Verified COVID-19
• Admission to medical ward within the last 24 hours
• Type 1 or type 2 diabetes prior to admission

The hospitalisation cohort - Exclusion criteria

• Cardiac arrhythmia at time of inclusion (previously diagnosed paroxysmal atrial fibrillation will be allowed)
• Pacemaker rhythm
• Severe valve disease

Withdrawal criteria

• The participants may withdraw at will at any time

Trial design

50 participants in 2 patient groups

The intensive care unit cohort

Description:

Patients (with or without diabetes) with COVID-19 admitted to the intensive care unit

Treatment:

Other: Glycaemic levels

The hospitalisation cohort

Description:

Patients with diabetes and COVID-19 admitted to the medical ward

Treatment:

Other: Glycaemic levels