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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diabetic patients from the University Hospital of Nancy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no intervention | Other | no intervention |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Describe the clinical and biological characteristics of patients with diabetes followed in routine care at the University Hospital of Nancy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Diabetic patients routinely followed by a specialist physician from the University Hospital of Nancy for diabetes
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Ludwig, Dr | Contact | +33383155056 | L.LUDWIG@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Lisa Ludwig, Dr | PA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Regional Hospital of Nancy | Recruiting | Nancy | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34241812 | Derived | 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. |
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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. | 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. | 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. | 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. | 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. | 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 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D018352 | Coronavirus Infections |
| D008659 | Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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