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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

202 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-17

Study Completion Date

2021-04-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Prospective, non-interventional, multicentric study

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Periodontal Treatment on Glycaemic Control in Diabetic Patients

NCT02563457

Diabetes

COMPLETED NA

COVID-19 Glycemic Control Study

NCT05977205

Type 1 Diabetes Type 2 Diabetes

COMPLETED

Diabetes and Psychological Profile

NCT01961466

Type 1 or 2 Diabetes

COMPLETED

Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes

NCT06896045

Diabetes Type 1

RECRUITING NA

Effect of Mental Stress on Glucose Control in Patients With Diabetes Mellitus

NCT01396330

Diabetes Mellitus Mental Stress

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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