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

Diabetes Mellitus, Type 2 Clinical Trial

— DIABETOVID  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05175677
• Other study ID #: DIABETOVID
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: February 2, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (6)

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. — View Citation

Ghosal S, Sinha B, Majumder M, Misra A. Estimation of effects of nationwide lockdown for containing coronavirus infection on worsening of glycosylated haemoglobin and increase in diabetes-related complications: A simulation model using multivariate regression analysis. Diabetes Metab Syndr. 2020 Jul-Aug;14(4):319-323. doi: 10.1016/j.dsx.2020.03.014. Epub 2020 Apr 10. — View 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. — View Citation

Ruissen MM, Regeer H, Landstra CP, Schroijen M, Jazet I, Nijhoff MF, Pijl H, Ballieux BEPB, Dekkers O, Huisman SD, de Koning EJP. Increased stress, weight gain and less exercise in relation to glycemic control in people with type 1 and type 2 diabetes during the COVID-19 pandemic. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e002035. doi: 10.1136/bmjdrc-2020-002035. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on diabetes control in the study population	This outcome corresponds to the HbA1c levels before (3 months before March 2020) and after containment (3 months after May 2020 decontainment).	Month 3
Secondary	Lifestyle modification for diabetic patients	This outcome corresponds to the weight variation before and after decontamination.	Month 3