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RecruitingNCT06437782HLQ-DiabeteUpdated Sep 14, 2026

Exploration of Health Literacy in Diabetes in Reunion Island and France

An observational study in Diabetes type1, Diabetes Type 2 and Diabetes, Gestational, sponsored by Centre Hospitalier Universitaire de la Réunion. Recruiting at 2 sites in Reunion. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Centre Hospitalier Universitaire de la Réunion · Observational

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,350
Ages
18 Years and older
Sex
All
01

Study 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. The main question[s] it aims to answer [is/are]:

Participants will complete the Health Literacy Questionnaire (HLQ) once.

02

Conditions studied

  • Diabetes type1
  • Diabetes Type 2
  • Diabetes, Gestational
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 1,350 is above the median of 300 across 1,741 observational studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Centre Hospitalier Universitaire de la Réunion is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,350 participants (estimated)
Patient registry
No

Groups and cohorts

  • type 1 diabetes closed loop

    Other: Questionnaire completion

  • type 2 diabetes

    Other: Questionnaire completion

  • Gestational diabetes

    Other: Questionnaire completion

Interventions

  • OtherQuestionnaire completion

    HLQ (Health Literacy questionnaire) will be completed by all included patients once.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: at inclusion

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06437782
Responsible party
Sponsor
First posted
May 31, 2024
Start date
Apr 17, 2025
Primary completion
Apr 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 14, 2026

Study contacts

Anna FLAUS
Contact
anna.flaus-furmaniuk@chu-reunion.fr
+262262905610
Xavier DEBUSSCHE
Contact
xavier.debussche@inserm.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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