"COVID-19 and Diabetes Outcomes"

NCT ID: NCT04324736

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5309 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2020-12-31

Brief Summary

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COVID-19 (Coronavirus Disease-2019) is a life-threatening infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that appeared in December 2019 in the Wuhan district. COVID-19 has since affected more than 150 countries across the world and especially France. The first epidemiological data, mostly from Chinese studies, indicate that diabetes is one of the most common comorbidities, with high blood pressure, in patients with COVID-19. Moreover, the presence of diabetes at admission would be a risk factor for both ICU hospitalization and death.

Nevertheless, specific data on people with diabetes and COVID-19 are fragmentary, justifying the achievement of a dedicated prospective observational study.

The French nationwide CORONADO study aims to specifically describe the phenotypic characteristics of patients with diabetes admitted to hospital with COVID-19 infection. Particular attention will be devoted to glycemic control at admission (i.e. the level of HbA1c), the diabetic complications, as well as anti-diabetic and antihypertensive therapies.

This study will provide answers to caregivers and patients with diabetes regarding the risk factors related to diabetes for COVID-19 prognosis. This pilot study will be used for the development of new studies and for the establishment of recommendations for the cost of care in patients with diabetes and COVID-19.

Detailed Description

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Conditions

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Coronavirus Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with diabetes

no interventional study

Intervention Type OTHER

no interventional study

Patients without diabetes

no interventional study

Intervention Type OTHER

no interventional study

Interventions

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no interventional study

no interventional study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients admitted in a hospital center since 10th march 2020
* Patients with COVID19 with biological proof (specific PCR) or with clinical and radiological diagnosis.
* Patient with diabetes known before the admission
* New onset diabetes discovered at admission (HbA1c value strictly greater than 6.5%)

Exclusion Criteria

* subjects opposed to the use of their data
* minors, adults under guardianship, protected persons
* subject having already been included in the CORONADO study (subject readmitted after discharge following the initial stay). Only the data of the first stay will be maintained.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Nantes

Nantes, , France

Site Status

Countries

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France

References

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Cariou B, Wargny M, Boureau AS, Smati S, Tramunt B, Desailloud R, Lebeault M, Amadou C, Ancelle D, Balkau B, Bordier L, Borot S, Bourgeon M, Bourron O, Cosson E, Eisinger M, Gonfroy-Leymarie C, Julla JB, Marchand L, Meyer L, Seret-Begue D, Simon D, Sultan A, Thivolet C, Vambergue A, Vatier C, Winiszewski P, Saulnier PJ, Bauduceau B, Gourdy P, Hadjadj S; CORONADO investigators. Impact of diabetes on COVID-19 prognosis beyond comorbidity burden: the CORONADO initiative. Diabetologia. 2022 Sep;65(9):1436-1449. doi: 10.1007/s00125-022-05734-1. Epub 2022 Jun 15.

Reference Type DERIVED
PMID: 35701673 (View on PubMed)

Tramunt B, Smati S, Coudol S, Wargny M, Pichelin M, Guyomarch B, Al-Salameh A, Amadou C, Barraud S, Bigot E, Bordier L, Borot S, Bourgeon M, Bourron O, Charriere S, Chevalier N, Cosson E, Feve B, Flaus-Furmaniuk A, Fontaine P, Galioot A, Gonfroy-Leymarie C, Guerci B, Lablanche S, Lalau JD, Larger E, Lasbleiz A, Laviolle B, Marre M, Munch M, Potier L, Prevost G, Renard E, Reznik Y, Seret-Begue D, Sibilia P, Thuillier P, Verges B, Gautier JF, Hadjadj S, Cariou B, Mauvais-Jarvis F, Gourdy P. Sex disparities in COVID-19 outcomes of inpatients with diabetes: insights from the CORONADO study. Eur J Endocrinol. 2021 Jul 5;185(2):299-311. doi: 10.1530/EJE-21-0068.

Reference Type DERIVED
PMID: 34085949 (View on PubMed)

Wargny M, Potier L, Gourdy P, Pichelin M, Amadou C, Benhamou PY, Bonnet JB, Bordier L, Bourron O, Chaumeil C, Chevalier N, Darmon P, Delenne B, Demarsy D, Dumas M, Dupuy O, Flaus-Furmaniuk A, Gautier JF, Guedj AM, Jeandidier N, Larger E, Le Berre JP, Lungo M, Montanier N, Moulin P, Plat F, Rigalleau V, Robert R, Seret-Begue D, Serusclat P, Smati S, Thebaut JF, Tramunt B, Vatier C, Velayoudom FL, Verges B, Winiszewski P, Zabulon A, Gourraud PA, Roussel R, Cariou B, Hadjadj S; CORONADO investigators. Predictors of hospital discharge and mortality in patients with diabetes and COVID-19: updated results from the nationwide CORONADO study. Diabetologia. 2021 Apr;64(4):778-794. doi: 10.1007/s00125-020-05351-w. Epub 2021 Feb 17.

Reference Type DERIVED
PMID: 33599800 (View on PubMed)

Wargny M, Gourdy P, Ludwig L, Seret-Begue D, Bourron O, Darmon P, Amadou C, Pichelin M, Potier L, Thivolet C, Gautier JF, Hadjadj S, Cariou B; CORONADO investigators. Type 1 Diabetes in People Hospitalized for COVID-19: New Insights From the CORONADO Study. Diabetes Care. 2020 Nov;43(11):e174-e177. doi: 10.2337/dc20-1217. Epub 2020 Aug 26. No abstract available.

Reference Type DERIVED
PMID: 32847826 (View on PubMed)

Cariou B, Hadjadj S, Wargny M, Pichelin M, Al-Salameh A, Allix I, Amadou C, Arnault G, Baudoux F, Bauduceau B, Borot S, Bourgeon-Ghittori M, Bourron O, Boutoille D, Cazenave-Roblot F, Chaumeil C, Cosson E, Coudol S, Darmon P, Disse E, Ducet-Boiffard A, Gaborit B, Joubert M, Kerlan V, Laviolle B, Marchand L, Meyer L, Potier L, Prevost G, Riveline JP, Robert R, Saulnier PJ, Sultan A, Thebaut JF, Thivolet C, Tramunt B, Vatier C, Roussel R, Gautier JF, Gourdy P; CORONADO investigators. Phenotypic characteristics and prognosis of inpatients with COVID-19 and diabetes: the CORONADO study. Diabetologia. 2020 Aug;63(8):1500-1515. doi: 10.1007/s00125-020-05180-x. Epub 2020 May 29.

Reference Type DERIVED
PMID: 32472191 (View on PubMed)

Other Identifiers

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RC20_0148

Identifier Type: -

Identifier Source: org_study_id

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