Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 202
- Locations
- 11
- Primary Endpoint
- HbA1c
Study Overview
Brief Summary
Prospective, non-interventional, multicentric study
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Ecologic Or Community
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
- •Patients agreeing to have their HbA1c measured between May 15 and July 31,
- •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.
Outcomes
Primary Outcomes
HbA1c
Time Frame: Baseline
The change in HbA1c over the first confinement period as compared to the value in early 2020.
Secondary Outcomes
- Stress(Baseline)