Diabetes Type 1EVASTRESSNCT06896045
Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
A study testing Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale in people with Diabetes Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 14 sites in France.
Trial summary
Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. 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?
- Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 14 sitesFrance
- Study dates
- 22 Apr 2025to 5 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Patient with a clinical diagnosis of type 1 diabetes of at least 1 year, as determined by the medical record;
- Patient aged at least 18 years;
- Patient treated with an external insulin pump for at least 2 months or with multi-injections;
- Patient with a smartphone compatible with iOS 15.0 or higher or Android 12.0 or higher;
- Patient with a smartphone with Bluetooth 5.0 or higher;
- Patient with HbA1c ≤ 10% with measurement ≤3 months;
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- Patient with no psychiatric pathology that could interfere with the study;
- Patient having signed the free and informed consent form to participate in the study;
- Patient affiliated to the French Social Security system;
- Patient agreeing not to eat between meals for the duration of the study (except for hypoglycaemia and/or snacks during physical activity);
- Patient agrees to wear an Empatica EmbracePlus watch for the duration of the study and to charge it according to the device's requirements for recording data;
- Patient agreed to wear an OURA ring for the duration of the study and to recharge it as required by the device to enable data recording (patients at the CERITD centre only).
Who cannot join
- Type 2 diabetic patient;
- Patient fitted with a closed loop (or artificial pancreas);
- Patient with any characteristic pathology that could interfere with the study (renal failure, unstabilised diabetic retinopathy, heart failure, heart attack within 6 months prior to inclusion, severe neuropathy, particularly autonomic neuropathy);
- Patients with a tendency to snack;
- Patients undergoing treatment with drugs known to significantly interfere with blood sugar levels or the adrenergic system, such as corticosteroids and beta-blockers;
- Patients undergoing atropine treatment (Hydroxyzine Chlorhydrate or Atarax®...), likely to modify the EDA (Electrodermal Activity) ;
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- Patients with a known allergy to latex (watch EmbracePlus);
- Pregnant woman;
- Nursing woman;
- Persons deprived of their liberty by judicial or administrative decision, persons under psychiatric care;
- Persons under guardianship or trusteeship or subject to a legal protection measure
- Persons who are not affiliated to a social security scheme or are beneficiaries of such a scheme.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites
Angers University Hospital
Angers, 49100
Avignon Hospital
Avignon, 84000
Bordeaux University Hospital
Bordeaux, 33075
Brest University Hospital
Brest, 29200
Dijon University Hospital
Dijon, 21079
CERITD (Centre d'Etudes et de Recherches pour l'Intensification du Traitement du Diabète)
Évry, 91058
Grenoble University Hospital
Grenoble, 38043
St Louis Hospital
La Rochelle, 17000
Lille University Hospital
Lille, 59037
DiabeCare diabetes centre
Lyon, 69008
European Hospital
Marseille, 13003
Private practice in endocrinology and metabolic diseases
Mérignac, 33700
Rennes University Hospital
Rennes, 35200
Strasbourg University Hospital
Strasbourg, 67091
About this study
Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. These closed-loop (CL) devices are capable of effectively regulating the conventional factors associated with glycaemic disturbance, namely dietary intake and physical activity. However, they do not account of stress, which some subjects with T1D perceive as a major disrupter of their blood sugar levels. One of the reasons for this is undoubtedly that stress, unlike diet or physical activity, cannot be anticipated. Since stress is difficult to predict, it is also more difficult to study. Its onset, intensity, duration and progression are linked to the subject's experience, psychological state and environment. Not all patients respond to stress triggers in the same way. Some patients appear to be more reactive than others to these agents, particularly when they are exposed to them chronically or repeatedly, in an anxiety-provoking environment. This is known as chronic psychosocial stress, and it is this type of stress that seems to be most closely associated with glycaemic disturbance in subjects with T1D, most often in the form of hyperglycaemia and, more rarely, hypoglycaemia. However, there are no solid epidemiological or experimental data to support these observations.
The study we propose is a prospective multicentre clinical trial in 125 subjects with T1D treated with insulin pumps or multi-injections at 14 French university centres. Our aim is to evaluate the relationship between interstitial glucose levels measured by CGM and perceived stress, assessed 4 times a day, away from mealtimes in order to avoid the impact of dietary glycaemia, using a "stressometer". This stressometer is an application designed by CERITD that can be downloaded to the patient's smartphone and consists of an electronic visual analogue scale (VAS) on which the level of stress felt is evaluated quantitatively (continuous value between 0 and 10).
- Conditions
- Diabetes Type 1
- Being tested
- Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale
- 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.
Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scaleBehavioural
In addition to stress assessment with the stress meter, patients will be fitted with a Continious Glucose Monitoring
| Study group | Role | What they receive |
|---|---|---|
| Visual analog scale to measure stress levels | Experimental | Not described Receives: Behavioral: Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between perceived daily stress, self-assessed on a multi-daily basis using a mobile subjective stress assessment application called a "stress meter", and blood glucose levels measured by continuous glucose monitoring (CGM)
Visual analogue scale to assess stress levels:
0: I feel absolutely no stress 10: I feel extremely stressed
Measured: 14 days
Secondary outcomes (41)
HbA1c measurement
HbA1c measurement at inclusion
Measured: At Inclusion
Characterization of 4 patient profiles according to the impact of daily stress on glycemic control
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: At inclusion
Number of days the Continuous subcutaneous Glucose Monitoring (CGM) worn
Measured: 14 days
Percentage of time the CGM is active (recommended at least 70% of the time)
Measured: 14 days
Percentage of sensor time in glucose level measured by the Dexcom One+ CGM time
- Percentage of time spent within the target 70-180 mg/dl (3.9-10.0 mmol/L) (TIR)
- Percentage of time <54 mg/dl (<3.0 mmol/L)
- Percentage of time spent in the range 54-69 mg/dl (3.0-3.8 mmol/L)
- Percentage <70 mg/dl (<3.9 mmol/L)
- Percentage of time >250 mg/dl (>13.9 mmol/L)
- Percentage of time spent in the range 181-250 mg/dl (10.1-13.9 mmol/L)
- Percentage of time >180 mg/dl (>10.0 mmol/L)
Measured: 14 days
Variability of the CGM glucose level
The glycemic variation coefficient (CV) intra patient CV≤36%, CV > 36%
Measured: 14 days
Glucose management Indicator (GMI)
Measured: 14 days
Average CGM glucose level
Measurement of glucose by CGM
Measured: 14 days
Glycaemic evolution over a period during which stress is measured.
Measurement of the area under the curve (AUC) for blood glucose
Measured: 14 days
Glycaemic evolution over a period during which stress is measured.
Measurement of the maximum blood sugar
Measured: 14 days
Glycaemic evolution over a period during which stress is measured.
Measurement of the blood sugar delta
Measured: 14 days
Glycaemic evolution over a period during which stress is measured.
Measurement of the blood sugar average
Measured: 14 days
Measuring heart rate with the Empatica EmbracePlus watch
Measured: 14 days
Measuring heart rate variability with the Empatica EmbracePlus watch
Measured: 14 days
Measuring electrodermal activity with the Empatica EmbracePlus watch
Measured: 14 days
Measuring heart rate with the Oura ring
Measured: 14 days
Measuring heart rate variability with the Oura ring
Measured: 14 days
Measuring accelerometry parameters with the Empatica EmbracePlus watch
Measured: 14 days
Measuring accelerometry parameters with the Oura ring
Measured: 14 days
Measuring the amount of sleep you get with the Empatica EmbracePlus watch
"Sleep detection" parameter
Measured: 14 days
Measuring the amount of sleep you get with the Oura ring
sleep score
Measured: 14 days
Measuring total sleep time with the Oura ring
Measured: 14 days
Assessment of sleep quality
Visual Analogue Sleep Scale filled in each morning with reference to the previous night 0: I slept very badly 10: I slept very well
Measured: 14 days
Measurement of sleep characteristics with the Oura ring
Sleep efficiency as a percentage
Measured: 14 days
Measurement of inflammatory biomarkers
Measured: at inclusion and after 14 days
Capillary cortisol measurement
Hair cortisol levels measured at the end of study.
Measured: After 14 days
Assessment of diabetes-related distress in the test population .
PAID (Problem Areas in Diabetes) is a self-administered 5-item scale. Each item is scored from 0 (not a problem) to 4 (serious problem).
Measured: at inclusion
Assessment of stress levels using the STAI questionnaire
State-Trait Anxiety Inventory (STAI)-Y1:
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").
Measured: At inclusion and after 14 days
Assessment of stress levels using the STAI questionnaire
State-Trait Anxiety Inventory STAI-Y2 (anxiety score): 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: After 14 days
Assessment of diabetes-related distress in the test population .
DDS T1 is an indicator of overall diabetes distress (average of 17 items, rated 1 to 6 on a scale).
A higher score indicates higher distress.
Measured: at inclusion and after 14 days
Evaluation of the perception of hypoglycaemia in the population tested with Clarke score
The Clarke questionnaire is comprised of eight questions to evaluate the hypoglycemia awareness. The answer for each individual question will represent a score (0 or 1). These scores will be summed together to a final score from 0 to 7, representing from normal to minimal/no hypoglycemia awareness.
Measured: at inclusion
Evaluation of the perception of hypoglycaemia in the population tested with Gold score
The Gold method is used to assess impaired awareness of hypoglycemia. The scale is from 1 to 7. A score of 4 or more indicates impaired awareness of hypoglycemia
Measured: at inclusion
Assessment of stress levels using the PSS-14 questionnaire (Perceived Stress Scale 14)
It is a five-point Likert-type scale and consists of 14 items. Participants rate each item on a scale ranging from "Never (0)" to "Very often (4)". Seven of the items with positive statements are scored in reverse. As the scores obtained from the scale increase, the perceived stress level of the person increases. PSS-14 scores range from 0 to 56, with 0-35 point range indicating normal stress level, 35-56 point range indicating that the individual is under stress
Measured: at inclusion and after 14 days
Assessment of stress levels : depression score
The Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For depression the cutoff scores are: Normal: 0-9, Mild: 10-12, Moderate:13-20, Severe: 21-27, and Extremely severe: 28-42.
Measured: After 7 days
Assessment of stress levels : anxiety score
The Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For anxiety the cutoff scores are: Normal: 0-6, Mild: 7-9, Moderate: 10-14, Severe:15-19, and Extremely severe: 20-42.
Measured: After 7 days
Assessment of stress levels : stress score
The Depression, Anxiety and Stress Scale 21 (DASS-21) is an inventory that will be used to identify the presence and intensity of depressive, anxiety and stress. For stress the cutoff scores are: Normal: 0-10, Mild:11-18, Moderate:19-26, Severe: 27-34, and Extremely severe: 35-42.
Measured: After 7 days
Diagnosis and measurement of the severity of depression: Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) will be used to assess depressive symptoms, including suicidal ideation, over the last two weeks (9 questions). Items are scored 0-3, resulting in a total score of 0-27. Higher scores indicate more symptoms of depression.
Measured: After 7 days
Personality traits : Big Five Inventory 10 (BFI-10)
Items range from 1 (strongly approves) to 5 (strongly disapproves). Scales: openness to experience, conscientiousness, extraversion, agreeableness and neuroticism
Measured: After 7 days
Bortner scale
The Bortner self-assessment questionnaire consists of 14 items. It is used to classify individuals according to types of behaviour (A and B)
Measured: After 7 days
Quality of life assessment: Short Form 36 questionnaire (SF-36)
Short Form 36 (SF-36) -ranges between 0 (maximum disability) and 100 (no disability). The SF36 score can be converted to utility scores using values within the questionnaire.
Measured: After 14 days
Assessment of sleep quality: Pittsburgh Sleep Quality Index (PSQI)
Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire comprising seven component scores (subjective sleep quality, sleep latency, duration of sleep, sleep efficiency habits, sleep disturbances, use of sleeping medication, and daytime dysfunction), is used to evaluate sleep quality over the last month
Measured: After 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start22 Apr 2025
- Primary completion5 Dec 2026 (estimated)
- Study completion5 Dec 2026 (estimated)
Why it stopped: The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
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
- NCT06896045
- Sponsor's protocol ID
- 2024-A02296-41
- Acronym
- EVASTRESS
- Status last verified
- May 2026
- First submitted
- 28 Feb 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Study Evaluating the Relationship Between Perceived Daily Stress Level and Glycemic Level in Subjects With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06896045
- Acronym / sponsor ID
- EVASTRESS / 2024-A02296-41
- Conditions
- Diabetes Type 1
- Keywords
- stress, glycemic control
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The sponsor has temporarily suspended participant enrollment due to operational constraints impacting study implementation. This decision is not related to safety concerns. The study is expected to resume once the identified issues are addressed.
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Centre d'Etudes et de Recherche pour l'Intensification du Traitement du DiabèteUniversity, hospital or other
- Study start
- 22 Apr 2025 (actual)
- Primary completion
- 5 Dec 2026 (estimated)
- Study completion
- 5 Dec 2026 (estimated)
- First posted
- 26 Mar 2025 (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.
Type 1 diabetes (T1D) affects around 200,000 people in France. The only treatment is insulin, administered either by multiple injections, by pump alone or, more recently, by automated insulin delivery systems (AIDs), which have resulted in a very significant improvement in glycaemic control and quality of life. These closed-loop (CL) devices are capable of effectively regulating the conventional factors associated with glycaemic disturbance, namely dietary intake and physical activity. However, they do not account of stress, which some subjects with T1D perceive as a major disrupter of their blood sugar levels. One of the reasons for this is undoubtedly that stress, unlike diet or physical activity, cannot be anticipated. Since stress is difficult to predict, it is also more difficult to study. Its onset, intensity, duration and progression are linked to the subject's experience, psychological state and environment. Not all patients respond to stress triggers in the same way. Some patients appear to be more reactive than others to these agents, particularly when they are exposed to them chronically or repeatedly, in an anxiety-provoking environment. This is known as chronic psychosocial stress, and it is this type of stress that seems to be most closely associated with glycaemic disturbance in subjects with T1D, most often in the form of hyperglycaemia and, more rarely, hypoglycaemia. However, there are no solid epidemiological or experimental data to support these observations.
The study we propose is a prospective multicentre clinical trial in 125 subjects with T1D treated with insulin pumps or multi-injections at 14 French university centres. Our aim is to evaluate the relationship between interstitial glucose levels measured by CGM and perceived stress, assessed 4 times a day, away from mealtimes in order to avoid the impact of dietary glycaemia, using a "stressometer". This stressometer is an application designed by CERITD that can be downloaded to the patient's smartphone and consists of an electronic visual analogue scale (VAS) on which the level of stress felt is evaluated quantitatively (continuous value between 0 and 10).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual analog scale to measure stress levels | Experimental | Behavioral: Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient with a clinical diagnosis of type 1 diabetes of at least 1 year, as determined by the medical record;
- Patient aged at least 18 years;
- Patient treated with an external insulin pump for at least 2 months or with multi-injections;
- Patient with a smartphone compatible with iOS 15.0 or higher or Android 12.0 or higher;
- Patient with a smartphone with Bluetooth 5.0 or higher;
Key exclusion criteria (12 listed)
- Type 2 diabetic patient;
- Patient fitted with a closed loop (or artificial pancreas);
- Patient with any characteristic pathology that could interfere with the study (renal failure, unstabilised diabetic retinopathy, heart failure, heart attack within 6 months prior to inclusion, severe neuropathy, particularly autonomic neuropathy);
- Patients with a tendency to snack;
- Patients undergoing treatment with drugs known to significantly interfere with blood sugar levels or the adrenergic system, such as corticosteroids and beta-blockers;
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 |
|---|---|---|
| Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scaleIn addition to stress assessment with the stress meter, patients will be fitted with a Continious Glucose Monitoring | Behavioural | Visual analog scale to measure stress levels |
Primary outcome
Correlation between perceived daily stress, self-assessed on a multi-daily basis using a mobile subjective stress assessment application called a "stress meter", and blood glucose levels measured by continuous glucose monitoring (CGM)
Time frame: 14 days
Visual analogue scale to assess stress levels: 0: I feel absolutely no stress 10: I feel extremely stressed
41 secondary outcomes
HbA1c measurement
Time frame: At Inclusion
Characterization of 4 patient profiles according to the impact of daily stress on glycemic control
Time frame: At inclusion
Number of days the Continuous subcutaneous Glucose Monitoring (CGM) worn
Time frame: 14 days
Percentage of time the CGM is active (recommended at least 70% of the time)
Time frame: 14 days
Percentage of sensor time in glucose level measured by the Dexcom One+ CGM time
Time frame: 14 days
Variability of the CGM glucose level
Time frame: 14 days
Glucose management Indicator (GMI)
Time frame: 14 days
Average CGM glucose level
Time frame: 14 days
Glycaemic evolution over a period during which stress is measured.
Time frame: 14 days
Glycaemic evolution over a period during which stress is measured.
Time frame: 14 days
Glycaemic evolution over a period during which stress is measured.
Time frame: 14 days
Glycaemic evolution over a period during which stress is measured.
Time frame: 14 days
Measuring heart rate with the Empatica EmbracePlus watch
Time frame: 14 days
Measuring heart rate variability with the Empatica EmbracePlus watch
Time frame: 14 days
Measuring electrodermal activity with the Empatica EmbracePlus watch
Time frame: 14 days
Measuring heart rate with the Oura ring
Time frame: 14 days
Measuring heart rate variability with the Oura ring
Time frame: 14 days
Measuring accelerometry parameters with the Empatica EmbracePlus watch
Time frame: 14 days
Measuring accelerometry parameters with the Oura ring
Time frame: 14 days
Measuring the amount of sleep you get with the Empatica EmbracePlus watch
Time frame: 14 days
Measuring the amount of sleep you get with the Oura ring
Time frame: 14 days
Measuring total sleep time with the Oura ring
Time frame: 14 days
Assessment of sleep quality
Time frame: 14 days
Measurement of sleep characteristics with the Oura ring
Time frame: 14 days
Measurement of inflammatory biomarkers
Time frame: at inclusion and after 14 days
Capillary cortisol measurement
Time frame: After 14 days
Assessment of diabetes-related distress in the test population .
Time frame: at inclusion
Assessment of stress levels using the STAI questionnaire
Time frame: At inclusion and after 14 days
Assessment of stress levels using the STAI questionnaire
Time frame: After 14 days
Assessment of diabetes-related distress in the test population .
Time frame: at inclusion and after 14 days
Evaluation of the perception of hypoglycaemia in the population tested with Clarke score
Time frame: at inclusion
Evaluation of the perception of hypoglycaemia in the population tested with Gold score
Time frame: at inclusion
Assessment of stress levels using the PSS-14 questionnaire (Perceived Stress Scale 14)
Time frame: at inclusion and after 14 days
Assessment of stress levels : depression score
Time frame: After 7 days
Assessment of stress levels : anxiety score
Time frame: After 7 days
Assessment of stress levels : stress score
Time frame: After 7 days
Diagnosis and measurement of the severity of depression: Patient Health Questionnaire (PHQ-9)
Time frame: After 7 days
Personality traits : Big Five Inventory 10 (BFI-10)
Time frame: After 7 days
Bortner scale
Time frame: After 7 days
Quality of life assessment: Short Form 36 questionnaire (SF-36)
Time frame: After 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Assess stress levels 4 times a day before meals (morning, noon and evening and at bedtime) using a visual analogue scale in people with Diabetes Type 1, run by Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète at 14 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 12 inclusion and 12 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: paused, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
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?
Correlation between perceived daily stress, self-assessed on a multi-daily basis using a mobile subjective stress assessment application called a "stress meter", and blood glucose levels measured by continuous glucose monitoring (CGM) (time frame: 14 days). 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 8 May 2026.