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
1 other identifier
observational
202
1 country
11
Brief Summary
Prospective, non-interventional, multicentric study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2021
CompletedFirst Submitted
Initial submission to the registry
June 10, 2021
CompletedFirst Posted
Study publicly available on registry
June 14, 2021
CompletedJune 23, 2021
June 1, 2021
9 months
June 10, 2021
June 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
The change in HbA1c over the first confinement period as compared to the value in early 2020.
Baseline
Secondary Outcomes (1)
Stress
Baseline
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- \- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Rennes University Hospital
Rennes, Brittany Region, 35033, France
Centre Hospitalier de l'Agglomération Montargoise
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 Hôpital Boisguillaume
Rouen, France
CH de Saint Malo
St-Malo, France
CHRU de Tours
Tours, 37170, France
Bretagne Atlantique Hospital
Vannes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fabrice BONNET
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- ECOLOGIC OR COMMUNITY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2021
First Posted
June 14, 2021
Study Start
June 17, 2020
Primary Completion
March 5, 2021
Study Completion
April 22, 2021
Last Updated
June 23, 2021
Record last verified: 2021-06