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Completed

NCT Number: NCT04924673

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

Prospective, non-interventional, multicentric study

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rennes University Hospital, Rennes, Brittany Region, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. HbA1c

    Time frame: Baseline

    The change in HbA1c over the first confinement period as compared to the value in early 2020.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Pr Pierre-Henri Ducluzeau, University of Tours, France

Registry information

Official study title

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

Acronym: COVIGLYSTRESS

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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