Study of the Impact of the COVID-19 Pandemic on the Management of Type 2 Diabetic Patients in a Sample in the Paris Region

Completed

• Conditions: COVID-19; Diabetes Mellitus, Type 2

• Registration Number: NCT05175677
• Lead Sponsor: Fondation Hôpital Saint-Joseph

Brief Summary

The Covid-19 crisis is undoubtedly the most significant event of the early 21st century. The pandemic has profoundly changed our way of life, whether as human beings, but also as patients or caregivers. This pandemic of an incredible magnitude, after having been minimized, blew a wind of fear on the whole world because of the unknown that the SARS-CoV2 virus represented. The world scientific community being destabilized, a great majority of states decided to apply a containment. In France, a strict containment was applied between March 17, 2020 and May 11, 2020 (1 month and 23 days, about 8 weeks). Diabetic and obese patients were designated as "at risk" for infection by COVID 19. Type 2 diabetes is one of the most common chronic diseases in general practice. Its regular management, we know, is largely related to lifestyle, which is particularly important in controlling the disease and preventing complications. During the first months of the pandemic, we witnessed many emergency room visits of patients with chronic pathologies, in full decompensation, due to a lack of follow-up but also due to a lack of treatment. After the first containment, in the endocrinology department of the Paris Saint-Joseph hospital, we observed that many patients had a clear imbalance of their diabetes compared to their previous history.

The main objective of this study is to show that the COVID-19 pandemic, and more precisely the strict confinement applied in France from March 17, 2020 to May 11, 2020, had an impact on diabetes control in the study population. The secondary objectives are to study the explanatory covariates via the modification of the lifestyle of diabetic patients (decrease in physical activity, increase in poor dietary habits, psychological impact related to the situation, difficulties in accessing care, modification of work arrangements).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-04
• Study Start: 2022-03-10
• Primary Completion: 2022-12-31
• Study Completion: 2023-02-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patient whose age ≥ 18 years
• Patients with type 2 diabetes
• Patient consulting their attending physician for the follow-up of their diabetes OR Patient consulting the GHPSJ diabetes service for the follow-up of their diabetes
• Patients who have an attending physician who follows their diabetes
• Patients living in the Paris region
• Francophone patients
• Patients who do not object to the use of their data for this research

Exclusion Criteria

• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under court protection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Impact on diabetes control in the study population	Month 3	This outcome corresponds to the HbA1c levels before (3 months before March 2020) and after containment (3 months after May 2020 decontainment).

Secondary Outcome Measures

Name	Time	Method
Lifestyle modification for diabetic patients	Month 3	This outcome corresponds to the weight variation before and after decontamination.

Trial Locations

Locations (1)

Groupe Hospitalier Paris Saint-Joseph; 🇫🇷 Paris, France