Diabetes Clinical Trial
— COVIGLYSTRESSOfficial title:
Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
Verified date | June 2021 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective, non-interventional, multicentric study
Status | Completed |
Enrollment | 202 |
Est. completion date | April 22, 2021 |
Est. primary completion date | March 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Adult patient (= 18 years old) - Diabetic patient (type 1 or type 2) regardless of their diabetes treatment who experienced complete confinement in their own home, in France. - Patients who had a measured HbA1 or an estimated HbA1c with a glucose sensor Freestyle libre with a known result, between November 1, 2019 and February 29, 2020. - Patients agreeing to have their HbA1c measured between May 15 and July 31, 2020. - Having been informed of the study and not objecting to participating in it Exclusion Criteria: - Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty. |
Country | Name | City | State |
---|---|---|---|
France | Brest University Hospital | Brest | |
France | CHU de Dijon | Dijon | |
France | CHU Grenoble | Grenoble | |
France | Hospices Civils Lyon | Lyon | |
France | Centre Hospitalier de l'Agglomération Montargoise | Montargis | Centre-Val De Loire |
France | GHRMSA | Mulhouse | |
France | Rennes University Hospital | Rennes | Bretagne |
France | CHU Rouen Hôpital Boisguillaume | Rouen | |
France | CH de Saint Malo | Saint-Malo | |
France | CHRU de Tours | Tours | |
France | Bretagne Atlantique Hospital | Vannes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Pr Pierre-Henri Ducluzeau, University of Tours, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1c | The change in HbA1c over the first confinement period as compared to the value in early 2020. | Baseline | |
Secondary | Stress | The level of stress as assessed by the GHQ questionnaire and the prevalence of a state of psychological distress (defined by a Likert index in the GHQ test 12 =14) both evaluated after the first confinement period in France and then 6 months later, in this population of diabetic patients. | Baseline |
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