Diabetes type1HLQ-DiabeteNCT06437782
Exploration of Health Literacy in Diabetes in Reunion Island and France
An observational study of Diabetes type1 and Diabetes Type 2, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
Trial summary
The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes type1, Diabetes Type 2, Diabetes, Gestational
- What is being tested?
- Questionnaire completion
- How many people
- 1,350 participants
- Where
- 2 sitesReunion
- Study dates
- 17 Apr 2025to Jun 2027
- Phase
- Observational
- 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
Study population: Patients with type 1 diabetes (strict insulin dependence, or anti-GAD, anti-IA2, and/or anti-ZnT8 + antibodies) with a hybrid closed-loop insulin therapy system for at least 3 months , diabetes of type 2 (non-insulin-dependent or insulin-requiring, with negative anti-GAD, anti-IA2, and/or anti-ZnT8 Ab if diabetes has been diagnosed for less than 5 years at the time of insulin therapy), or diabetes during pregnancy: gestational diabetes (diabetes diagnosed during pregnancy according to the diagnostic criteria of French recommendations), or pre-existing diabetes (known or not) with pregnancy.
Who may be able to join
- Patient with type 1, 2 or gestational diabetes taken care in hospital
Who cannot join
- Patient unable to understand and respect study procedures
- Patient with cognitive disorder
- Patient with serious acute complication due to diabetes within 15 days before inclusion
- Stroke history with neurologic consequences
- Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Xavier DEBUSSCHE contact
Reunion2 sites, 2 recruiting
- Not yet recruiting
CHU de La Réunion
Saint-Denis, 97400
Anna FLAUS, anna.flaus-furmaniuk@chu-reunion.fr
Anna FLAUS, MD
- Recruiting
CHU de La Réunion
Saint-Denis
Anna FLAUS, +262692995210, anna.flaus-furmaniuk@chu-reunion.fr
Anna FLAUS, MD
About this study
Official title: Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France
The goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question[s] it aims to answer [is/are]:
Participants will complete the Health Literacy Questionnaire (HLQ) once.
- Conditions
- Diabetes type1, Diabetes Type 2, Diabetes, Gestational
- Being tested
- Questionnaire completion
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire completionOther
HLQ (Health Literacy questionnaire) will be completed by all included patients once.
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes closed loop | Not described Receives: Other: Questionnaire completion | |
| type 2 diabetes | Not described Receives: Other: Questionnaire completion | |
| Gestational diabetes | Not described Receives: Other: Questionnaire completion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health literacy profiles in Reunion Island
HLQ (Health literacy questionnaire) is completed once. The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy.
Measured: at inclusion
Secondary outcomes (1)
Health literacy profiles in Reunion Island and France
HLQ (Health literacy questionnaire) is completed once. Health literacy profile in patients treated on Reunion Island et France will be described.
The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy.
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start17 Apr 2025
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437782
- Sponsor's protocol ID
- 2017/CHU/13
- Acronym
- HLQ-Diabete
- Status last verified
- Sep 2026
- First submitted
- 22 May 2024
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France
- ClinicalTrials.gov ID
- NCT06437782
- Acronym / sponsor ID
- HLQ-Diabete / 2017/CHU/13
- Conditions
- Diabetes type1, Diabetes Type 2, Diabetes, Gestational
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,350 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 31 May 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 goal of this observational study is to identify the health literacy profile of diabetic patients in Reunion Island and France in order to obtain information to improve access to information, therapeutic education and to health service. The main question[s] it aims to answer [is/are]:
Participants will complete the Health Literacy Questionnaire (HLQ) once.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes closed loop | – | Other: Questionnaire completion |
| type 2 diabetes | – | Other: Questionnaire completion |
| Gestational diabetes | – | Other: Questionnaire completion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 diabetes (strict insulin dependence, or anti-GAD, anti-IA2, and/or anti-ZnT8 + antibodies) with a hybrid closed-loop insulin therapy system for at least 3 months , diabetes of type 2 (non-insulin-dependent or insulin-requiring, with negative anti-GAD, anti-IA2, and/or anti-ZnT8 Ab if diabetes has been diagnosed for less than 5 years at the time of insulin therapy), or diabetes during pregnancy: gestational diabetes (diabetes diagnosed during pregnancy according to the diagnostic criteria of French recommendations), or pre-existing diabetes (known or not) with pregnancy.
Key inclusion criteria (1 listed)
- Patient with type 1, 2 or gestational diabetes taken care in hospital
Key exclusion criteria (5 listed)
- Patient unable to understand and respect study procedures
- Patient with cognitive disorder
- Patient with serious acute complication due to diabetes within 15 days before inclusion
- Stroke history with neurologic consequences
- Other specific types of diabetes : chronic calcific pancreatitis, iatrogenic, other secondary diabetes, rare monogenic or genetic diabetes due to insulin resistance
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 completionHLQ (Health Literacy questionnaire) will be completed by all included patients once. | Other | Gestational diabetes, type 1 diabetes closed loop, type 2 diabetes |
Primary outcome
Health literacy profiles in Reunion Island
Time frame: at inclusion
HLQ (Health literacy questionnaire) is completed once. The algorithm produces unweighted scores for each of the 9 scales of the HLQ. The final score for each scale is an average score across all the questions that form that scale. The HLQ does not provide one overall summative score; rather it gives you nine separate scores that indicate a person's strengths and needs in relation to their health literacy.
1 secondary outcome
Health literacy profiles in Reunion Island and France
Time frame: at 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 14 Sep 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.
Xavier DEBUSSCHE contact
2 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 type1 and Diabetes Type 2, run by Centre Hospitalier Universitaire de la Réunion at 2 sites in Reunion.
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 1 inclusion and 5 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 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Reunion. 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 Anna FLAUS (+262262905610, anna.flaus-furmaniuk@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health literacy profiles in Reunion Island (time frame: at 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 14 Sep 2026.