## Protocol Section
### Identification Module
**NCT ID:** NCT06437782

**Acronym:** HLQ-Diabete

**Brief Title:** Exploration of Health Literacy in Diabetes in Reunion Island and France

**Official Title:** Exploration of Health Literacy in Diabetes in Reunion Island and Metropolitan France

#### Organization Study ID Info
**ID:** 2017/CHU/13
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de la Réunion
### Status Module
#### Completion Date
**Date:** 2025-11

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-09

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-22
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de la Réunion

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Diabetes type1

- Diabetes Type 2

- Diabetes, Gestational

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1350

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Questionnaire completion

**Label:** type 1 diabetes closed loop

#### Arm Group 2

**Intervention Names:**

- Other: Questionnaire completion

**Label:** type 2 diabetes

#### Arm Group 3

**Intervention Names:**

- Other: Questionnaire completion

**Label:** Gestational diabetes

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Gestational diabetes

- type 1 diabetes closed loop

- type 2 diabetes

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

**Name:** Questionnaire completion

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Health literacy profiles in Reunion Island

**Time Frame:** at inclusion

#### Secondary Outcomes

**Description:** 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.

**Measure:** Health literacy profiles in Reunion Island and France

**Time Frame:** at inclusion

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** anna.flaus-furmaniuk@chu-reunion.fr

**Name:** Anna FLAUS

**Phone:** +262262905610

**Role:** CONTACT

**Contact 2:**

**Email:** xavier.debussche@inserm.fr

**Name:** Xavier DEBUSSCHE

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Saint-Denis

**Contacts:**

***Contact 1:***

- **Email:** anna.flaus-furmaniuk@chu-reunion.fr

- **Name:** Anna FLAUS

- **Role:** CONTACT

***Contact 2:***

- **Name:** Anna FLAUS, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Réunion

**Facility:** CHU de La Réunion

**Zip:** 97400

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M19012

- Name: Diabetes, Gestational

- Relevance: HIGH

- As Found: Diabetes, Gestational

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: HIGH

- As Found: Diabetes

- ID: M7119

- Name: Diabetes Mellitus, Type 2

- Relevance: HIGH

- As Found: Diabetes Type 2

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Diabetes Type 1

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000016640

- Term: Diabetes, Gestational

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000003924

- Term: Diabetes Mellitus, Type 2

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### Misc Info Module

- Version Holder: 2024-05-31
