Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes

Diabetes Mellitus Clinical Trial

— CONFI-DIAB  

Official title:

Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes: a Monocentric Cross-sectional Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04485351
• Other study ID #: 2020PI137
• Status: Recruiting
• Start date: July 2020
• Est. completion date: September 2020

Study information

• Verified date: June 2020
• Source: Central Hospital, Nancy, France
• Contact: Lisa Ludwig, Dr
• Phone: +33383155056
• Email: L.LUDWIG[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and the COVID-19 (Coronavirus Disease-2019) in December 2019 has led to an unprecedented international health situation. Exceptional measures have been taken by public authorities worldwide in order to slow the spread of the virus and prevent healthcare systems from becoming overloaded. In France, a national lockdown has been established during approximately 2 months to increase social distancing and restrict population movements. Hospital routine care appointments have been cancelled, in order to reallocate medical resources towards COVID-19 units and limit contacts between patients within hospitals or waiting rooms. While the virus itself, the disease and potential treatments are currently extensively studied, little data are available on the effect of these public health decisions on the management of a chronic condition such as diabetes.

The French regional CONFI-DIAB study aims at assessing the collateral impact of routine care cancellation during the national lockdown due to COVID-19 in patients with a chronic condition such as diabetes. Special attention will be given to metabolic control and access to health care.

This cross-sectional study should provide information on the consequences of a global lockdown and the associated routine care cancellation on the management of diabetes, and inform future decision making in the event of a new pandemic.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: September 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients

• Patient with diabetes known for at least 6 months before inclusion

• Patient followed by a specialist physician from the University Hospital of Nancy for routine care within the 6 months prior to the lockdown.

• Patient who was assessed for prioritization of care following the end of the lockdown by the department of endocrinology, diabetology and nutrition

Exclusion Criteria:

• Subjects opposed to the use of their data

• Minors, adults under guardianship, protected persons

Related Conditions & MeSH terms

• Coronavirus Infection
• Coronavirus Infections
• Diabetes Mellitus
• Glucose Metabolism Disorders
• Metabolic Disease
• Metabolic Diseases
• Severe Acute Respiratory Syndrome

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
France	University Regional Hospital of Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare glycated hemoglobin levels of patients with diabetes from the University Hospital of Nancy between the period preceding and following the lockdown related to the COVID-19 pandemic.	HbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.	6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Secondary	Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy	Use type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records	6 weeks period following the end of the lockdown
Secondary	Describe the change from baseline of biological and clinical parameters of patients with diabetes followed in routine care at the University Hospital of Nancy between the period preceding and following the lockdown.	Use BMI, lipid profile, renal and hepatic function from medical records	6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Secondary	Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.	Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization	6 weeks period following the end of the lockdown
Secondary	Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.	Proportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation	6 weeks period following the end of the lockdown
Secondary	Describe the proportion of patients who changed their lifestyle's habits during the lockdown.	Porportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco	6 weeks period following the end of the lockdown
Secondary	Describe healthcare consumption of patients with diabetes during the lockdown.	Proportion of patients who consulted their GP, a specialist physician, pharmacist, biologist, nurse, paramedic, other healthcare professional; type of visit (regular face to face, telemedecine); method for prescription renewal; reason for delay in care; hospitalization (excluding for COVID-19)	6 weeks period following the end of the lockdown
Secondary	Describe the proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.	Proportion of patients who (1) was tested for SARS-CoV-2 by PCR, (2) developped COVID-19 confirmed by PCR and (3) was hospitalized due to the severity of COVID-19.	6 weeks period following the end of the lockdown