Clinical trial NCT04485351: Assessing the Impact of the COVID-19 Lockdown on Metabolic Control and Access to Health Care in Patients With Diabetes
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Coronavirus Infection
Metabolic Disease
Glucose Metabolism Disorders
Keywords: diabetes mellitus
lockdown
covid-19
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
Secondary outcomes:
measure: Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy
timeFrame: 6 weeks period following the end of the lockdown
measure: 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.
timeFrame: 6 months period prior to lockdown - 6 weeks period following the end of the lockdown
measure: Describe the proportion of patients who presented with one or more significant clinical event during the lockdown.
timeFrame: 6 weeks period following the end of the lockdown
measure: Describe the proportion of patients who forgot and/or discontinued one or several medication(s) during the lockdown.
timeFrame: 6 weeks period following the end of the lockdown
measure: Describe the proportion of patients who changed their lifestyle's habits during the lockdown.
timeFrame: 6 weeks period following the end of the lockdown
measure: Describe healthcare consumption of patients with diabetes during the lockdown.
timeFrame: 6 weeks period following the end of the lockdown
measure: 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.
timeFrame: 6 weeks period following the end of the lockdown
Other outcomes:
Locations:
city: Nancy
country: France
facility: University Regional Hospital of Nancy
Study officials:
affiliation: PA
name: Lisa Ludwig, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.