DiabetesCOVIGLYSTRESSNCT04924673
Impact of the COVID-19 Epidemic on Glycemic Balance and the Level of Stress in Diabetic Patients
An observational study of Diabetes, run by Rennes University Hospital at 11 sites in France.
Trial summary
Prospective, non-interventional, multicentric study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 202 participants
- Where
- 11 sitesFrance
- Study dates
- 17 Jun 2020to 22 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Brest University Hospital
Brest, 29000
CHU de Dijon
Dijon, 21000
CHU Grenoble
Grenoble
Hospices Civils Lyon
Lyon
Centre Hospitalier de l'Agglomération Montargoise
Montargis, Centre-Val de Loire, 45207
GHRMSA
Mulhouse
Rennes University Hospital
Rennes, Brittany Region, 35033
CHU Rouen Hôpital Boisguillaume
Rouen
CH de Saint Malo
St-Malo
CHRU de Tours
Tours, 37170
Bretagne Atlantique Hospital
Vannes
About this study
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
Prospective, non-interventional, multicentric study
Read the 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.
- Conditions
- Diabetes
- Keywords
- COVID 19, Diabetes, Stress, HbA1c
- Medical subject headings
- Diabetes Mellitus, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
The change in HbA1c over the first confinement period as compared to the value in early 2020.
Measured: Baseline
Secondary outcomes (1)
Stress
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start17 Jun 2020
- Primary completion5 Mar 2021
- Study completion22 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Pr Pierre-Henri Ducluzeau, University of Tours, France
- Responsible party
- Sponsor
- Investigators
- Fabrice BONNET, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924673
- Sponsor's protocol ID
- 35RC20_9780_COVIGLYSTRESS
- Acronym
- COVIGLYSTRESS
- Status last verified
- Jun 2021
- First submitted
- 10 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04924673
- Acronym / sponsor ID
- COVIGLYSTRESS / 35RC20_9780_COVIGLYSTRESS
- Conditions
- Diabetes
- Keywords
- COVID 19, Diabetes, Stress, HbA1c
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Pr Pierre-Henri Ducluzeau, University of Tours, France
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 22 Apr 2021 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Adults over the age of legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HbA1c
Time frame: Baseline
The change in HbA1c over the first confinement period as compared to the value in early 2020.
1 secondary outcome
Stress
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2021.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabrice BONNET principal investigator
Rennes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by Rennes University Hospital at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2021.