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

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ClinicalTrials.gov Identifier: NCT04485351
Recruitment Status : Recruiting
First Posted : July 24, 2020
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment
Diabetes Mellitus Coronavirus Infection Metabolic Disease Glucose Metabolism Disorders Other: no intervention

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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : September 2020


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




Primary Outcome Measures :
  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. [ 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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)

  7. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04485351


Contacts
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Contact: Lisa Ludwig, Dr +33383155056 L.LUDWIG@chru-nancy.fr

Locations
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France
University Regional Hospital of Nancy Recruiting
Nancy, France
Contact: Lisa Ludwig, Dr         
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Lisa Ludwig, Dr PA
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT04485351    
Other Study ID Numbers: 2020PI137
First Posted: July 24, 2020    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
diabetes mellitus
lockdown
covid-19
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Diabetes Mellitus
Metabolic Diseases
Glucose Metabolism Disorders
Endocrine System Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases