Exploration of Health Literacy in Diabetes in Reunion Island and France (HLQ-Diabete)

July 28, 2025 updated by: Centre Hospitalier Universitaire de la Réunion

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Réunion
      • Saint-Denis, Réunion, 97400
      • Saint-Denis, Réunion
        • Recruiting
        • CHU de la réunion
        • Principal Investigator:
          • Michael JOUBERT, Pr
        • Principal Investigator:
          • Anna FLAUS, MD
        • Contact:
        • Principal Investigator:
          • Laurent MEYER, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

Patient with type 1, 2 or gestational diabetes taken care in hospital

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
type 2 diabetes
Other: Questionnaire completion
HLQ (Health Literacy questionnaire) will be completed by all included patients once.
type 1 diabetes closed loop
Other: Questionnaire completion
HLQ (Health Literacy questionnaire) will be completed by all included patients once.
Gestational diabetes
Other: Questionnaire completion
HLQ (Health Literacy questionnaire) will be completed by all included patients once.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health literacy profiles in Reunion Island and France
Time Frame: at inclusion

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.
at inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de la Réunion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 17, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 22, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/CHU/13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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