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

NCT04485351 | Unknown

• 1 other identifier: 2020PI137
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Coronavirus Infection; Metabolic Disease; Glucose Metabolism Disorders

Keywords

diabetes mellitus; lockdown; covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy

  6 weeks period following the end of the lockdown

• 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.

  6 months period prior to lockdown - 6 weeks period following the end of the lockdown

• Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.

  6 weeks period following the end of the lockdown

• Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.

  6 weeks period following the end of the lockdown

• Describe the proportion of patients who changed their lifestyle's habits during the lockdown.

  6 weeks period following the end of the lockdown

Study Arms (1)

Diabetic patients from the University Hospital of Nancy

Other: no intervention

Interventions

no intervention OTHER

no intervention

Diabetic patients from the University Hospital of Nancy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes

You may qualify if:

• Adult patients
• 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

You may not qualify if:

• Subjects opposed to the use of their data
• Minors, adults under guardianship, protected persons

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

University Regional Hospital of Nancy

Nancy, France

RECRUITING

Related Publications (1)

• Ludwig L, Scheyer N, Remen T, Guerci B. The Impact of COVID-19 Lockdown on Metabolic Control and Access to Healthcare in People with Diabetes: the CONFI-DIAB Cross-Sectional Study. Diabetes Ther. 2021 Aug;12(8):2207-2221. doi: 10.1007/s13300-021-01105-y. Epub 2021 Jul 9.

  PMID: 34241812 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Coronavirus Infections; Metabolic Diseases; Glucose Metabolism Disorders; COVID-19

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Lisa Ludwig, Dr

  PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Ludwig, Dr

CONTACT

+33383155056; L.LUDWIG@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 24, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2020
• Study Completion: September 1, 2020
• Last Updated: July 24, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)