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

July 23, 2020 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France
        • Recruiting
        • University Regional Hospital of Nancy
        • Contact:
          • Lisa Ludwig, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diabetic patients from the University Hospital of Nancy
Other: no intervention
no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy
Time Frame: 6 weeks period following the end of the lockdown
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
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.
Time Frame: 6 months period prior to lockdown - 6 weeks period following the end of 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
Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.
Time Frame: 6 weeks period following the end of the lockdown
Ketosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
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.
Time Frame: 6 weeks period following the end of 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
Describe the proportion of patients who changed their lifestyle's habits during the lockdown.
Time Frame: 6 weeks period following the end of 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
Describe healthcare consumption of patients with diabetes during the lockdown.
Time Frame: 6 weeks period following the end of 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
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.
Time Frame: 6 weeks period following the end of the lockdown
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Lisa Ludwig, Dr, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2020

Primary Completion (ANTICIPATED)

August 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

July 2, 2020

First Submitted That Met QC Criteria

July 23, 2020

First Posted (ACTUAL)

July 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2020

Last Update Submitted That Met QC Criteria

July 23, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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