Diabetes MellitusDIAMINDNCT07392437
Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
A study testing Questionnaire and Physical Exam in people with Diabetes Mellitus and Psychological Distress, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Psychological Distress
- What is being tested?
- Questionnaire and Physical Exam
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteFrance
- Study dates
- 15 Apr 2026to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Adults (age ≥ 18 years).
- Diagnosed with type 2 diabetes according to national (HAS) criteria, whether newly diagnosed or longstanding, with or without chronic complications, and with no restriction regarding HbA1c level. Patients with mixed diabetes (type 2 diabetes associated with pancreatic disease) may also be included if all of the following criteria are met: pancreatic disease detected on imaging, preserved C-peptide levels (> 200 pmol/L in the presence of normal blood glucose levels), and BMI ≥ 25 kg/m².
- Able to understand the study information and to complete the self-administered questionnaires.
- Affiliated to the French social security system.
- Has not objected to participation in the study (non-opposition procedure).
Who cannot join
- Age < 18 years.
- Pregnant woman.
- Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes).
- Haemochromatosis.
- Cystic fibrosis.
- Current treatment with one of the following hyperglycaemic therapies: oral corticosteroids, immunosuppressive drugs, dopaminergic agonists, interferon-alpha, or protease inhibitors.
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- History of partial or total pancreatectomy.
- Ongoing genetic work-up for atypical diabetes.
- Non-French-speaking patient.
- Major neurocognitive disorder or physical/mental disability preventing completion of the questionnaires.
- Adult under legal protection (guardianship or curatorship).
- Refusal or subsequent withdrawal of non-opposition.
- Any later paraclinical result finally revealing a type of diabetes other than type 2 diabetes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice
CAROLI-BOSC Philippe, Dr, 4 92 03 21 87 ext. +33, caroli-bosc.p@chu-nice.fr
About this study
Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment.
This single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.
- Conditions
- Diabetes Mellitus, Psychological Distress
- Being tested
- Questionnaire and Physical Exam
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire and Physical ExamBehavioural
Patients will be asked to complete questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Not described Receives: Behavioral: Questionnaire and Physical Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40)
Diabetes-related distress will be assessed using the Problem Areas In Diabetes scale (PAID-20). The PAID-20 includes 20 items scored from 0 to 4; the total raw score (0-80) is multiplied by 1.25 to obtain a total score ranging from 0 to 100, with higher scores indicating greater diabetes-related distress. Severe diabetes-related distress is defined as a PAID-20 total score ≥ 40. The primary endpoint is the proportion of participants with PAID-20 ≥ 40.
Measured: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Secondary outcomes (2)
Prevalence of severe diabetes-related distress by care setting (ambulatory vs hospitalized)
Using the PAID-20 total score (0-100; higher scores indicate greater distress, severe distress defined as ≥ 40), the proportion of participants with severe diabetes-related distress will be calculated in two predefined subgroups: ambulatory patients (outpatient clinic and day hospital) and hospitalized patients (conventional hospitalization in endocrinology).
Measured: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Factors associated with diabetes-related distress (PAID-20 score)
The PAID-20 total score (0-100; higher scores indicate greater diabetes-related distress) will be analysed as a continuous variable. Decision-tree models (CHAID/CRT) will be used to explore associations between diabetes-related distress and predefined clinical, psychosocial and lifestyle variables.
Measured: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2026
- Study start15 Apr 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe CAROLI-BOSC, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07392437
- Sponsor's protocol ID
- 25-PP-21
- Acronym
- DIAMIND
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Diabetes-related Distress Among Patients Living With Type 2 Diabetes in a University Hospital Center and Identification of Its Associated Factors.
- ClinicalTrials.gov ID
- NCT07392437
- Acronym / sponsor ID
- DIAMIND / 25-PP-21
- Conditions
- Diabetes Mellitus, Psychological Distress
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 6 Feb 2026 (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.
Diabetes-related distress is a psychological construct associated with poorer glycaemic control in people living with diabetes. In France, few data are available on this topic and none focus specifically on adults with type 2 diabetes. Diabetes-related distress is not mentioned in the current French national guidelines on the management of type 2 diabetes, whereas international societies such as the ADA and, more recently, the EASD now recommend its regular assessment.
This single-centre observational study conducted in the endocrinology department of Nice University Hospital aims to estimate the prevalence of severe diabetes-related distress in adults with type 2 diabetes receiving usual care, and to identify associated clinical, psychosocial and lifestyle factors. Participants complete validated self-report questionnaires (PAID-20 for diabetes distress, WHOQOL-BREF for quality of life, and a modified Starting The Conversation dietary questionnaire), and clinical data are extracted from electronic medical records. The study does not modify usual medical management and participation consists only in completing the questionnaires and receiving feedback on the results.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Behavioral: Questionnaire and Physical Exam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (age ≥ 18 years).
- Diagnosed with type 2 diabetes according to national (HAS) criteria, whether newly diagnosed or longstanding, with or without chronic complications, and with no restriction regarding HbA1c level. Patients with mixed diabetes (type 2 diabetes associated with pancreatic disease) may also be included if all of the following criteria are met: pancreatic disease detected on imaging, preserved C-peptide levels (> 200 pmol/L in the presence of normal blood glucose levels), and BMI ≥ 25 kg/m².
- Able to understand the study information and to complete the self-administered questionnaires.
- Affiliated to the French social security system.
- Has not objected to participation in the study (non-opposition procedure).
Key exclusion criteria (13 listed)
- Age < 18 years.
- Pregnant woman.
- Any type of diabetes other than type 2 diabetes (e.g. type 1 diabetes, secondary or genetic diabetes).
- Haemochromatosis.
- Cystic fibrosis.
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 |
|---|---|---|
| Questionnaire and Physical ExamPatients will be asked to complete questionnaires. | Behavioural | Patients |
Primary outcome
Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40)
Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Diabetes-related distress will be assessed using the Problem Areas In Diabetes scale (PAID-20). The PAID-20 includes 20 items scored from 0 to 4; the total raw score (0-80) is multiplied by 1.25 to obtain a total score ranging from 0 to 100, with higher scores indicating greater diabetes-related distress. Severe diabetes-related distress is defined as a PAID-20 total score ≥ 40. The primary endpoint is the proportion of participants with PAID-20 ≥ 40.
2 secondary outcomes
Prevalence of severe diabetes-related distress by care setting (ambulatory vs hospitalized)
Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Factors associated with diabetes-related distress (PAID-20 score)
Time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
Philippe CAROLI-BOSC, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire and Physical Exam in people with Diabetes Mellitus and Psychological Distress, run by Centre Hospitalier Universitaire de Nice at 1 site 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 13 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe CAROLI-BOSC, Dr (+33 4 92 03 21 87, caroli-bosc.p@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of severe diabetes-related distress (PAID-20 score ≥ 40) (time frame: Baseline (single assessment during usual care visit, within 3 days from inclusion)). 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 28 Oct 2026.