NCT06437782

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,350

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Apr 2025Jun 2026

First Submitted

Initial submission to the registry

May 22, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

April 17, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

12 months

First QC Date

May 22, 2024

Last Update Submit

July 28, 2025

Conditions

Outcome Measures

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.

    at inclusion

Secondary Outcomes (1)

  • Health literacy profiles in Reunion Island and France

    at inclusion

Study Arms (3)

type 1 diabetes closed loop

Other: Questionnaire completion

type 2 diabetes

Other: Questionnaire completion

Gestational diabetes

Other: Questionnaire completion

Interventions

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

Gestational diabetestype 1 diabetes closed looptype 2 diabetes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patient unable to understand and respect study procedures
  • Patient with cognitive disorder
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de La Réunion

Saint-Denis, 97400, Reunion

NOT YET RECRUITING

CHU de La Réunion

Saint-Denis, Reunion

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes, Gestational

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2024

First Posted

May 31, 2024

Study Start

April 17, 2025

Primary Completion

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations