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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.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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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
What is being tested?
Questionnaire completion
How many people
1,350 participants
Where
2 sitesReunion
Study dates
17 Apr 2025to Jun 2027
Phase
Observational

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.

Reunion2 sites, 2 recruiting
  • CHU de La Réunion

    Saint-Denis, 97400

    Anna FLAUS, anna.flaus-furmaniuk@chu-reunion.fr

    Anna FLAUS, MD

    Not yet recruiting
  • CHU de La Réunion

    Saint-Denis

    Anna FLAUS, +262692995210, anna.flaus-furmaniuk@chu-reunion.fr

    Anna FLAUS, MD

    Recruiting

Other trials in Reunion

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.

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 groups in NCT06437782
Study groupRoleWhat they receive
type 1 diabetes closed loopNot described
Receives: Other: Questionnaire completion
type 2 diabetesNot described
Receives: Other: Questionnaire completion
Gestational diabetesNot described
Receives: Other: Questionnaire completion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)
  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.

  1. First posted31 May 2024
  2. Study start17 Apr 2025
  3. Primary completionApr 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
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

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