Interactive Educational Video for Paediatric Type 1 Diabetes

NCT07639307 | Not Yet Recruiting

• 1 other identifier: Interactive video
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary aim of this study is to evaluate the effectiveness of an interactive educational video (Luca's Journey: Managing Type 1 Diabetes) delivered in addition to the standard educational programme, in improving metabolic control in children with type 1 diabetes mellitus, specifically focusing on the change in glycated haemoglobin (HbA1c) levels between baseline (T0) and six-month follow-up (T3). The study will also assess the effectiveness of the intervention in improving fasting blood glucose levels, frequency of hypoglycaemic and hyperglycaemic episodes, clinical and anthropometric variables (blood pressure, body weight, BMI, and waist circumference), acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes, and adherence to the main type 1 diabetes management activities. The secondary objectives were to compare the two educational modalities (intervention vs. standard educational programme) in terms of: (i) mean between-group difference in the change in fasting blood glucose levels and frequency of hypoglycaemic and hyperglycaemic episodes; (ii) mean between-group difference in the change in clinical and anthropometric variables; (iii) acquisition of nutritional knowledge based on recommendations for the management of type 1 diabetes; and (iv) adherence to the main type 1 diabetes management activities. The main research questions addressed in this study are: Does the interactive educational video improve metabolic control, as measured by HbA1c levels, in children with type 1 diabetes compared to standard education alone? Does the intervention lead to a greater reduction in fasting blood glucose levels and a lower frequency of hypoglycaemic and hyperglycaemic episodes? Does the intervention improve clinical and anthropometric variables compared to standard education alone? Does the intervention lead to a greater acquisition of nutritional knowledge in children with type 1 diabetes? Does the intervention improve adherence to the main type 1 diabetes management activities, including insulin administration, blood glucose monitoring, dietary behaviours, and physical activity? Both study groups will receive the standard in-person educational programme, as routinely delivered at the outpatient clinic of the Regional Centre for Paediatric Diabetology of the "SS. Annunziata" University Hospital in Chieti. Participants assigned to the intervention group will additionally receive a 25-minute interactive educational video immediately following the standard educational session. The interactive video follows a child with type 1 diabetes through everyday situations, inviting participants to make decisions at key moments and explore the consequences of different behavioural choices related to diabetes management.

Conditions

Diabete Type 1; Educational Videos

Keywords

Diabete Type 1; Educational Videos; metabolic control; Glycemic Control; children

Outcome Measures

Primary Outcomes (1)

• Change in glycated haemoglobin (HbA1c) levels from baseline to 6-month follow-up

  Glycated haemoglobin (HbA1c) will be assessed at baseline (T0) and at six-month follow-up (T3) using capillary blood samples collected through the glycaemic monitoring devices in use by each patient, including Continuous Glucose Monitoring Systems (CGMS) and/or Continuous Subcutaneous Insulin Infusion (CSII) devices. HbA1c reflects long-term glycaemic control over the preceding 2-3 months and is considered the primary indicator of the effectiveness of daily diabetes self-management. A clinically meaningful change is defined as a between-group difference in HbA1c greater than 0.5% (5.5 mmol/mol). Unit of Measure: Percentage points (%) of HbA1c.

  Assessed at Baseline (T0) and 6 months (T3).

Secondary Outcomes (9)

• Change in Fasting Blood Glucose (FBS) levels from baseline to 6-month follow-up

  Assessed at baseline (T0) and 6 months (T3)

• Change in Frequency of Hypoglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up

  Assessed at baseline (T0) and 6 months (T3)

• Change in Frequency of Hyperglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up

  Assessed at baseline (T0) and 6 months (T3)

• Change in Blood Pressure (Systolic and Diastolic) Assessed by Standard Sphygmomanometer From Baseline to 6-Month Follow-up

  Assessed at baseline (T0) and 6 months (T3)

• Change in Body Weight Assessed by Standard Scale From Baseline to 6-Month Follow-up

  Assessed at baseline (T0) and 6 months (T3)

Study Arms (2)

Interactive Educational Video

EXPERIMENTAL

Participants assigned to the intervention group will receive, in addition to the standard educational programme, a 25-minute interactive educational video entitled Luca's Journey: Managing Type 1 Diabetes, delivered on computers available at the outpatient clinic of the Regional Centre for Paediatric Diabetology of the "SS. Annunziata" University Hospital in Chieti, on the same day as the standard educational session. The video depicts a typical day in the life of Luca, an 8-year-old child with type 1 diabetes, and covers five key aspects of paediatric diabetes management: recognising carbohydrates, managing hyperglycaemia, choosing low-sugar snacks, preparing for physical activity, and managing hypoglycaemia. At key moments, participants choose between two options, each leading to a different narrative outcome, allowing children to actively explore the consequences of different behavioural choices in everyday diabetes management situations.

Other: Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes)

Traditional face-to-face education

ACTIVE COMPARATOR

Participants assigned to the control group will receive the standard in-person educational programme, as routinely delivered at the outpatient clinic of the Regional Centre for Paediatric Diabetology of the "SS. Annunziata" University Hospital in Chieti. The educational session, lasting approximately 25 minutes, will be delivered orally by a paediatric nurse with expertise in diabetology and a diabetologist. Prior to the intervention, the two professionals will hold three preliminary meetings to jointly plan the delivery of the session, defining their respective roles, timings, and the sequence of thematic areas. The session covers six key aspects of paediatric type 1 diabetes management: (i) basic information on type 1 diabetes; (ii) food and carbohydrates; (iii) nutritional labels and informed food choices; (iv) hyperglycaemia: symptoms and management; (v) management of physical activity; and (vi) hypoglycaemia: symptoms and treatment.

Other: Traditional Face-to-Face Education

Interventions

Traditional Face-to-Face Education OTHER

The standard face-to-face educational session will be tailored to the cognitive and developmental characteristics of the target age group (8-14 years), adapting content complexity, language, and communication style to ensure comprehensibility and engagement, while maintaining consistent educational goals across participants. Understanding will be supported through verbal interaction and age-appropriate explanations provided by the paediatric nurse and diabetologist. The educational session covers six key thematic areas: basic information on type 1 diabetes, food and carbohydrates, nutritional labels and informed food choices, hyperglycaemia symptoms and management, physical activity management, and hypoglycaemia symptoms and treatment, consistent with current guidelines on diabetes management.

Traditional face-to-face education

Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes) OTHER

The interactive educational video intervention will be tailored to the cognitive and developmental characteristics of the target age group (8-14 years), adapting content complexity, language, narrative structure, and interactive elements to ensure comprehensibility and engagement, while maintaining consistent educational goals across participants. Understanding will be supported through immediate visual feedback following each interactive choice, explaining in simple terms the consequences of each behavioural option. The interactive structure of the video, based on branching narratives, will promote active learning and critical thinking.

Interactive Educational Video

Eligibility Criteria

• Age: 8 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male and female children aged between 8 and 14 years
• Diagnosis of type 1 diabetes mellitus for at least 6 months
• Ability to understand and communicate in Italian
• Absence of psychiatric disorders
• Absence of cognitive impairment
• Ability to use digital devices (e.g., computer)
• Written informed consent for study participation and personal data-processing provided by both parents or the legal guardian

You may not qualify if:

• Age younger than 8 years or older than 14 years
• Diagnosis of type 1 diabetes mellitus for less than 6 months
• Inability to understand or communicate in Italian
• Presence of psychiatric disorders
• Presence of cognitive impairment
• Inability to use digital devices (e.g., computer)
• Refusal of assent by the child
• Failure to provide written informed consent for study participation and personal data processing by both parents or the legal guardian

Sponsors & Collaborators

• G. d'Annunzio University: lead

Central Study Contacts

Valentina Simonetti, Associate Professor

CONTACT

+39 (0871) 541205; v.simonetti@unich.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 10, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share