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| Name | Class |
|---|---|
| Pr Pierre-Henri Ducluzeau, University of Tours, France | UNKNOWN |
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Prospective, non-interventional, multicentric study
The rapid spread of the COVID-19 pandemic and the isolation at home implemented in France, creates unprecedented challenges for diabetic patients.
Patients with diabetes have been considered to be at higher risk of infection by the virus, with a greater risk of mortality; this has been a great source of anxiety for them.
It is well known that stress has an impact on plasma glucose levels. The French situation where a general confinement has been decreed over the whole territory (which is not the case for all countries) and for a period of two months, makes it possible to study the impact of this unique situation on stress, sedentary lifestyle, changes in diet and decrease in physical activity. There are no similar experiences described in the literature.
The investigators hypothesize there will be an increase of HbA1c in the coming months.
The main objective is to assess changes in glycemic control in diabetic patients after the confinement period.
The secondary objectives are to:
This is an observational, prospective, multicenter study. Participation in the study will be offered to all consecutive patients seen in Diabetes consultations, who meet the selection criteria.
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| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | The change in HbA1c over the first confinement period as compared to the value in early 2020. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
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Participation in the study will be offered to consecutive diabetic patients (both type 1 and type 2) in Diabetes consultations, who meet the selection criteria; recruitment will be from 11 academic hospitals in France.
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| Name | Affiliation | Role |
|---|---|---|
| Fabrice BONNET | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes University Hospital | Rennes | Brittany Region | 35033 | France | ||
| Centre Hospitalier de l'Agglomération Montargoise |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Montargis |
| Centre-Val de Loire |
| 45207 |
| France |
| Brest University Hospital | Brest | 29000 | France |
| CHU de Dijon | Dijon | 21000 | France |
| CHU Grenoble | Grenoble | France |
| Hospices Civils Lyon | Lyon | France |
| GHRMSA | Mulhouse | France |
| CHU Rouen HĂ´pital Boisguillaume | Rouen | France |
| CH de Saint Malo | St-Malo | France |
| CHRU de Tours | Tours | 37170 | France |
| Bretagne Atlantique Hospital | Vannes | France |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |