Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients (COVIGLYSTRESS)
Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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:
- Evaluate the prevalence of a state of psychological distress (which could be described as post-traumatic) following this epidemic situation in a population of patients with diabetes and to determine the main characteristics of patients with such a state of psychological distress.
- Study the evolution of the psychological state at a distance from confinement (6 months later) with the same questionnaire.
- Analyze characteristics of lifestyle during confinement: food (snacking), frequency of leaving home, sleep disorders and assess a possible association with variations in HbA1c.
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Brest, Frankrike, 29000
- Brest University Hospital
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Dijon, Frankrike, 21000
- CHU de Dijon
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Grenoble, Frankrike
- CHU Grenoble
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Lyon, Frankrike
- Hospices Civils Lyon
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Mulhouse, Frankrike
- GHRMSA
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Rouen, Frankrike
- CHU Rouen Hôpital Boisguillaume
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Saint-Malo, Frankrike
- CH de Saint Malo
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Tours, Frankrike, 37170
- CHRU de Tours
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Vannes, Frankrike
- Bretagne Atlantique Hospital
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Bretagne
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Rennes, Bretagne, Frankrike, 35033
- Rennes University hospital
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Centre-Val De Loire
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Montargis, Centre-Val De Loire, Frankrike, 45207
- Centre Hospitalier de l'Agglomération Montargoise
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HbA1c
Tidsram: Baseline
|
The change in HbA1c over the first confinement period as compared to the value in early 2020.
|
Baseline
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Stress
Tidsram: Baseline
|
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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Fabrice BONNET, Rennes University hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 35RC20_9780_COVIGLYSTRESS
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