Serious Game in the Therapeutic Education of Type 1 Diabetes Paediatric Patients

NCT03520855 | Completed

• 2 other identifiers: K150907J2017-A02052-51
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the contribution of a serious game in the reinforcement of knowledge acquired during therapeutic education of type 1 diabetes paediatric patients. This evaluation will take place within 3 months of the diagnosis.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Paediatrics patients

Outcome Measures

Primary Outcomes (1)

• Diapason questionnaire (Aide aux Jeunes Diabètes)

  50 questions (disease, treatment, food,…)

  3 months

Secondary Outcomes (5)

• HbA1c dosage

  3 months

• Number of hypo or hyperglycaemia

  3 months

• Evaluation of self-care skills

  3 months

• Evaluation of well-being with WHOFIVE

  3 months

• Evaluation of well-being with DQOLY

  3 months

Study Arms (2)

ETP + Serious game

EXPERIMENTAL

patients receiving the serious game additionally to the classic therapeutic education

Other: Serious game; Behavioral: ETP

ETP

ACTIVE COMPARATOR

patients under classic therapeutic education

Behavioral: ETP

Interventions

Serious game OTHER

DIVE software will be accessible via internet, children and parents will have to their disposition a room at the hospital specifically to work on the software. The DIVE software is organized in chapters, each matches an item of the therapeutic education process and ends with a knowledge assessment. The child has to end every chapter and succeed every evaluation to pursue on the next chapter. Measures will be taken in order to avoid contamination bias between groups. Children will have to connect to DIVE 2 times per week for a time duration of at last 1 hour.

ETP + Serious game

ETP BEHAVIORAL

Initial therapeutic education only will be applied in this group, with the help of doctors and nurses, based on theoretical educational lessons, reported on the AJD book. Health education sessions will also be taught by nurses.

ETP; ETP + Serious game

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Child aged from 10 to 17 and 8 months
• Child with internet access and with a computer or a tablet or a mobile phone in at least one of the two parents or legal representative(s)
• Informed consent signed by parents or legal representative(s) (only one parent possible)
• Beneficiary of a social security system

You may not qualify if:

• No internet access or no computer or no tablet or no mobile phone at home available
• No French language proficiency of the infant or legal representative(s)
• Inability to understand the game's instructions
• Inability to understand or fill the consent

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Necker Hospital

Paris, Paris, 75015, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jacques BELTRAND, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 11, 2018
• Study Start: April 3, 2019
• Primary Completion: August 30, 2023
• Study Completion: November 27, 2024
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)