Diabetes Type 1EPISTRESS2NCT06365255
National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
An observational study of Diabetes Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 11 sites in France.
Trial summary
The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Type 1
- What is being tested?
- questionnaires
- How many people
- 1,344 participants
- Where
- 11 sitesFrance
- Study dates
- 17 Jan 2023to 28 Feb 2024
- 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: To study the impact of stress on glycaemia, we chose to conduct an epidemiological study in France on a population of type 1 diabetic patients (T1DM). Many patients frequently and systematically cite stress as a frequent cause, or even the main cause, of the deterioration in their glycaemic control.
Who may be able to join
- Patients with type 1 diabetes;
- Do not have a psychiatric pathology;
- At least 18 years old;
- Affiliated to the Social Security;
- Having read the non-opposition form and not objecting to it.
Who cannot join
- Patient who has declared his opposition using the electronic non-opposition form
- Patient with type 2 diabetes
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Angers University Hospital
Angers, 49100
Avignon Hospital
Avignon, 84000
St André Hospital
Bordeaux, 33076
Brest University Hospital
Brest, 29200
Dijon University Hospital
Dijon, 21079
CERITD
Évry, 91058
Grenoble University Hospital
Grenoble, 38043
Lille University Hospital
Lille, 59037
APHM- La Conception Hospital
Marseille, 13000
Private practice in endocrinology and metabolic diseases
Mérignac, 33700
Srasbourg University Hospital
Strasbourg, 67091
About this study
The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.
In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.
- Conditions
- Diabetes Type 1
- Being tested
- questionnaires
- Keywords
- Stress, Glycemic control
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnairesOther
filling in questionnaires
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.
Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels. This questionnaire was designed and developed by CERITD to assess the impact of perceived stress on blood glucose levels in T1DM patients.
Measured: 30 minutes
Secondary outcomes (4)
Identify sub-populations of patients who feel stressed
- Identify and profile a sub-population of patients whose blood glucose levels rise in response to stress
- Identify and profile a sub-population of patients whose blood glucose levels decrease in response to stress
Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels
Measured: 30 minutes
Establish and categorise the different stress factors
Cungi brief stress evaluation scales The Cungi 1 scale is composed of 8 items. This questionnaire assesses patient stressors.
The maximum score is 48, the minimum score is 8. A high score reflects a large number of stressors
The Cungi 2 scale is composed of 11 items. This questionnaire assesses the patient's sensitivity to stress.
The maximum score is 66, the minimum score is 11. A high score reflects a high senstivity of stress.
Measured: 30 minutes
Establishing a relationship between personality type and the impact of stress
State-Trait Anxiety Inventory (STAI) questionnaire. The STAI-Y1 is composed of 20 items. This questionnaire assesses how the patient feels at the present moment. Patients are asked to score each question on a four-point scale (from 1 - corresponding to "not at all" to 4 - "much")
The STAI-Y2 is composed of 20 items. This questionnaire assesses how the patient feels in general.
Patients are asked to answer each question on a four-point scale (from 1 - corresponding to "almost never" to 4 - "almost always").
Measured: 30 minutes
Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities
EQ-5D-5L (European Quality of Life 5 Dimensions) questionnaire The EQ-5D-5L assesses five health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is rated on five levels of severity. The levels of severity for each dimension ranges from no problems (1) to extreme problems/unable to perform (5)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start17 Jan 2023
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Type 1Studies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 1,344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvia Franc, MD, Principal investigator, Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365255
- Sponsor's protocol ID
- 2022-A01453-40
- Acronym
- EPISTRESS2
- Status last verified
- Apr 2024
- First submitted
- 8 Apr 2024
- Last updated
- 17 Apr 2024
- 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 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Epidemiological Study of the Possible Impact of Stress on Glycaemic Control in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06365255
- Acronym / sponsor ID
- EPISTRESS2 / 2022-A01453-40
- Conditions
- Diabetes Type 1
- Keywords
- Stress, Glycemic control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,344 participants (actual)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 15 Apr 2024 (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.
The EPISTRESS2 study is a one-off cross-sectional epidemiological survey, carried out via an online form in patients with type 1 diabetes followed up by participating investigating centres.
In type 1 diabetes (T1DM), studies on stress and its impact on glycaemia have led to ambiguous results, mainly because there are no solid epidemiological or experimental data in the literature. The aim of this study was to assess the impact of perceived stress on blood glucose levels in a population of subjects with T1DM at 10 national centres.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To study the impact of stress on glycaemia, we chose to conduct an epidemiological study in France on a population of type 1 diabetic patients (T1DM). Many patients frequently and systematically cite stress as a frequent cause, or even the main cause, of the deterioration in their glycaemic control.
Key inclusion criteria (5 listed)
- Patients with type 1 diabetes;
- Do not have a psychiatric pathology;
- At least 18 years old;
- Affiliated to the Social Security;
- Having read the non-opposition form and not objecting to it.
Key exclusion criteria (2 listed)
- Patient who has declared his opposition using the electronic non-opposition form
- Patient with type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairesfilling in questionnaires | Other | – |
Primary outcome
The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps.
Time frame: 30 minutes
Questionnaire for Assessing the Impact of Stress on Blood Sugar Levels. This questionnaire was designed and developed by CERITD to assess the impact of perceived stress on blood glucose levels in T1DM patients.
4 secondary outcomes
Identify sub-populations of patients who feel stressed
Time frame: 30 minutes
Establish and categorise the different stress factors
Time frame: 30 minutes
Establishing a relationship between personality type and the impact of stress
Time frame: 30 minutes
Evaluation of the quality of life score obtained according to the 4 profiles and/or personalities
Time frame: 30 minutes
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 17 Apr 2024.
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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.
Sylvia Franc, MD principal investigator
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
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 Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète 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 2 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 17 Apr 2024. 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?
The primary endpoint is the characterisation of 4 profiles of patients with type 1 diabetes on insulin pumps. (time frame: 30 minutes). 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 17 Apr 2024.