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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04485351
Acronym
CONFI-DIAB
Enrollment
700
Registered
2020-07-24
Start date
2020-07-31
Completion date
2020-09-30
Last updated
2020-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

diabetes mellitus, lockdown, covid-19

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.

Interventions

OTHERno intervention

no intervention

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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.6 months period prior to lockdown - 6 weeks period following the end of the lockdownHbA1c levels before and after the lockdown period. A 3 months period is required between the 2 values.

Secondary

MeasureTime frameDescription
Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy6 weeks period following the end of the lockdownUse type of diabetes, BMI, lipid profile, micro- and macro-comorbidities and usual therapies from medical records
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 lockdownUse BMI, lipid profile, renal and hepatic function from medical records
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 lockdownProportion of patients who forgot and/or discontinued one or several medication(s), medication involved, duration and frequency of omission/discontinuation
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 lockdownKetosis, Ketoacidosis, severe hypoglycemia, COVID-19 infection, hospitalization
Describe healthcare consumption of patients with diabetes during the lockdown.6 weeks period following the end of the lockdownProportion 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)
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-19.6 weeks period following the end of the lockdownProportion 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.
Describe the proportion of patients who changed their lifestyle's habits during the lockdown.6 weeks period following the end of the lockdownPorportion of patients who modified their usual level of physical activity and/or their consumption of alcohol and/or tobacco

Countries

France

Contacts

Primary ContactLisa Ludwig, Dr
L.LUDWIG@chru-nancy.fr+33383155056

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026