Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients (COVIGLYSTRESS)

June 17, 2021 updated by: Rennes University Hospital

Study of the Changes in Glycemic Control and Psychological Distress in Diabetic Patients After the Confinement Period Related to the COVID-19 Epidemic

Prospective, non-interventional, multicentric study

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

202

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29000
        • Brest University Hospital
      • Dijon, France, 21000
        • CHU de Dijon
      • Grenoble, France
        • CHU Grenoble
      • Lyon, France
        • Hospices Civils Lyon
      • Mulhouse, France
        • GHRMSA
      • Rouen, France
        • CHU Rouen Hôpital Boisguillaume
      • Saint-Malo, France
        • CH de Saint Malo
      • Tours, France, 37170
        • Chru de Tours
      • Vannes, France
        • Bretagne Atlantique Hospital
    • Bretagne
      • Rennes, Bretagne, France, 35033
        • Rennes University Hospital
    • Centre-Val De Loire
      • Montargis, Centre-Val De Loire, France, 45207
        • Centre Hospitalier de l'Agglomération Montargoise

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c
Time Frame: Baseline
The change in HbA1c over the first confinement period as compared to the value in early 2020.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Collaborators

Pr Pierre-Henri Ducluzeau, University of Tours, France

Investigators

  • Principal Investigator: Fabrice BONNET, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2020

Primary Completion (Actual)

March 5, 2021

Study Completion (Actual)

April 22, 2021

Study Registration Dates

First Submitted

June 10, 2021

First Submitted That Met QC Criteria

June 10, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 23, 2021

Last Update Submitted That Met QC Criteria

June 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC20_9780_COVIGLYSTRESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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