Clinical trial NCT05175677: Study of the Impact of the COVID-19 Pandemic on the Management of Type 2 Diabetic Patients in a Sample in the Paris Region
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Diabetes Mellitus, Type 2
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes, consulting between 01/09/2021 and 31/12/2021 their attending physician for the follow-up of their diabetes or the GHPSJ diabetes service for the follow-up of their diabetes who have an attending physician who follows their diabetes and living in the Paris region.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Impact on diabetes control in the study population
timeFrame: Month 3
Secondary outcomes:
measure: Lifestyle modification for diabetic patients
timeFrame: Month 3
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint-Joseph
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Olivier Dupuy, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Fernandez E, Cortazar A, Bellido V. Impact of COVID-19 lockdown on glycemic control in patients with type 1 diabetes. Diabetes Res Clin Pract. 2020 Aug;166:108348. doi: 10.1016/j.diabres.2020.108348. Epub 2020 Jul 22.
citation: Ruiz-Roso MB, Knott-Torcal C, Matilla-Escalante DC, Garcimartin A, Sampedro-Nunez MA, Davalos A, Marazuela M. COVID-19 Lockdown and Changes of the Dietary Pattern and Physical Activity Habits in a Cohort of Patients with Type 2 Diabetes Mellitus. Nutrients. 2020 Aug 4;12(8):2327. doi: 10.3390/nu12082327.
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citation: Karatas S, Yesim T, Beysel S. Impact of lockdown COVID-19 on metabolic control in type 2 diabetes mellitus and healthy people. Prim Care Diabetes. 2021 Jun;15(3):424-427. doi: 10.1016/j.pcd.2021.01.003. Epub 2021 Jan 9.
citation: Tanji Y, Sawada S, Watanabe T, Mita T, Kobayashi Y, Murakami T, Metoki H, Akai H. Impact of COVID-19 pandemic on glycemic control among outpatients with type 2 diabetes in Japan: A hospital-based survey from a country without lockdown. Diabetes Res Clin Pract. 2021 Jun;176:108840. doi: 10.1016/j.diabres.2021.108840. Epub 2021 Apr 30.