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

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Recruiting
CT.gov ID
NCT05175677
Collaborator
(none)
100
1
9.7
10.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Study of the Impact of the COVID-19 Pandemic on the Management of Type 2 Diabetic Patients in a Sample in the Paris Region
    Actual Study Start Date :
    Mar 10, 2022
    Anticipated Primary Completion Date :
    Aug 9, 2022
    Anticipated Study Completion Date :
    Dec 31, 2022

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Lifestyle modification for diabetic patients [Month 3]

      This outcome corresponds to the weight variation before and after decontamination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Groupe Hospitalier Paris Saint-Joseph Paris France 75014

    Sponsors and Collaborators

    • Groupe Hospitalier Paris Saint Joseph

    Investigators

    • Principal Investigator: Olivier Dupuy, MD, Groupe Hospitalier Paris Saint Joseph

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Groupe Hospitalier Paris Saint Joseph
    ClinicalTrials.gov Identifier:
    NCT05175677
    Other Study ID Numbers:
    • DIABETOVID
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 30, 2022