Clinical trial NCT04924673: Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients
Official title: Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: COVID 19
Diabetes
Stress
HbA1c
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Pr Pierre-Henri Ducluzeau, University of Tours, France
First posted: 2021-06-14
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: Baseline
Secondary outcomes:
measure: Stress
timeFrame: Baseline
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes University Hospital
state: Bretagne
city: Montargis
country: France
facility: Centre Hospitalier de l'Agglomération Montargoise
state: Centre-Val De Loire
city: Brest
country: France
facility: Brest University Hospital
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hospices Civils Lyon
city: Mulhouse
country: France
facility: GHRMSA
city: Rouen
country: France
facility: CHU Rouen Hôpital Boisguillaume
city: Saint-Malo
country: France
facility: CH de Saint Malo
city: Tours
country: France
facility: CHRU de Tours
city: Vannes
country: France
facility: Bretagne Atlantique Hospital
Study officials:
affiliation: Rennes University Hospital
name: Fabrice BONNET
role: PRINCIPAL_INVESTIGATOR
References: