Interactive Educational Video for Paediatric Type 1 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-14
SponsorG. d'Annunzio University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes)
Other interventionThe 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.
Traditional Face-to-Face Education
Other interventionThe 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.
Treatment groups
110 Participants
are divided into 2 treatment groupsGroup A: Interactive Educational VideoExperimental treatment 1 intervention
Group B: Traditional face-to-face educationActive comparator 1 intervention
Trial outcomes
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.
Time frame
Assessed at Baseline (T0) and 6 months (T3).Secondary outcomes
1
Change in Fasting Blood Glucose (FBS) levels from baseline to 6-month follow-up
Capillary fasting blood glucose (FBS) will be assessed at baseline (T0) and at six-month follow-up (T3). Measurements will be collected through fingerstick capillary blood sampling (destrostick). Unit of Measure: mg/dL (milligrams per decilitre), with higher values indicating poorer fasting glycaemic control.
Time frame
Assessed at baseline (T0) and 6 months (T3)2
Change in Frequency of Hypoglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up
Hypoglycaemic episodes occurring in the preceding month will be assessed at baseline (T0) and at six-month follow-up (T3). Episodes will be collected either through fingerstick capillary blood sampling (destrostick) or through the glycaemic monitoring devices in use by each patient, including Continuous Glucose Monitoring Systems (CGMS) and/or Continuous Subcutaneous Insulin Infusion (CSII) devices, and classified as mild, moderate, or severe. Unit of Measure: Presence or absence of hypoglycaemic episodes in the preceding month (Yes/No) and severity (Mild/Moderate/Severe).
Time frame
Assessed at baseline (T0) and 6 months (T3)3
Change in Frequency of Hyperglycaemic Episodes (Mild, Moderate, and Severe) Assessed by Glycaemic Monitoring Devices or Fingerstick From Baseline to 6-Month Follow-up
Hyperglycaemic episodes occurring in the preceding month will be assessed at baseline (T0) and at six-month follow-up (T3). Episodes will be collected either through fingerstick capillary blood sampling (destrostick) or through the glycaemic monitoring devices in use by each patient, including Continuous Glucose Monitoring Systems (CGMS) and/or Continuous Subcutaneous Insulin Infusion (CSII) devices, and classified as mild, moderate, or severe. Unit of Measure: Presence or absence of hyperglycaemic episodes in the preceding month (Yes/No) and severity (Mild/Moderate/Severe)
Time frame
Assessed at baseline (T0) and 6 months (T3)4
Change in Blood Pressure (Systolic and Diastolic) Assessed by Standard Sphygmomanometer From Baseline to 6-Month Follow-up
Blood pressure (BP) will be assessed using a standard sphygmomanometer at baseline (T0) and at six-month follow-up (T3). Measurements will be extracted from the clinical records of the Paediatric Diabetology Centre of the "SS. Annunziata" University Hospital in Chieti. Both systolic and diastolic blood pressure values will be recorded separately. Higher values indicate poorer cardiovascular control. Unit of Measure: mmHg.
Time frame
Assessed at baseline (T0) and 6 months (T3)Locations
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Source ClinicalTrials.gov
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