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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
110
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.
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.
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).
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)
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)
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)
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)
Change in Body Weight Assessed by Standard Scale From Baseline to 6-Month Follow-up
Body weight will be assessed using a standard scale 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. A single measurement will be recorded at each time point. Higher values indicate greater body weight. Unit of Measure: Kilograms (kg), with higher values indicating greater body weight.
Time frame: Assessed at baseline (T0) and 6 months (T3)
Change in Body Mass Index (BMI) Calculated From Height and Weight Measurements From Baseline to 6-Month Follow-up
Body Mass Index (BMI) will be calculated from height (cm) and weight (kg) measurements extracted from the clinical records of the Paediatric Diabetology Centre of the "SS. Annunziata" University Hospital in Chieti at baseline (T0) and at six-month follow-up (T3). BMI will be calculated as weight in kilograms divided by height in metres squared (kg/m²). Higher values indicate greater adiposity. Unit of Measure: kg/m².
Time frame: Assessed at baseline (T0) and at six-month follow-up (T3)
Change in Waist Circumference Assessed by Standard Tape Measure From Baseline to 6-Month Follow-up
Waist circumference will be assessed 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. A single measurement will be recorded at each time point. Higher values indicate greater abdominal adiposity. Unit of Measure: Centimetres (cm).
Time frame: Assessed at baseline (T0) and at six-month follow-up (T3)
Change in Nutritional Knowledge Assessed by the Nutrition Knowledge Survey (NKS) From Baseline to 6-Month Follow-up
Nutritional knowledge will be assessed using the Nutrition Knowledge Survey (NKS), an instrument developed and validated in children and adolescents with type 1 diabetes aged 8-18 years (mean age 13.3 ± 2.9 years). The NKS includes 23 multiple-choice items, each with four response options of which only one is correct, examining four thematic areas: healthy food choices, carbohydrate counting, glycaemic response of foods, and reading of nutritional labels. Each correct response is assigned a score of 1; incorrect responses receive a score of 0. The total NKS score will be calculated as the percentage of correct responses among all completed items. Scores range from 0 to 100%, with higher scores indicating greater nutritional knowledge. Unit of Measure: Percentage of correct responses on the NKS score, range 0-100%.
Time frame: Assessed at baseline (T0), immediately post-intervention (T1), three months post-intervention (T2), and at six-month follow-up (T3).
Change in Adherence to Diabetes Management Activities Assessed by the Diabetes Management Questionnaire (DMQ) From Baseline to 6-Month Follow-up
Adherence to diabetes management activities will be assessed using the Diabetes Management Questionnaire (DMQ), an instrument developed and validated in children and adolescents with type 1 diabetes aged 8-18 years. The DMQ comprises 20 items exploring four key domains: insulin administration, blood glucose monitoring, dietary behaviours, and physical activity; plus one additional item (item 21) concerning the mean frequency of blood glucose monitoring over the past month. Each item will be assigned a score ranging from 0 to 4; six of the 20 items will be reverse-scored. The mean of all completed items will be calculated and subsequently multiplied by 25 to normalise the score on a scale of 0 to 100. Higher total scores correspond to greater adherence to diabetes management. Unit of Measure: Score on the DMQ, range 0-100, with higher scores indicating greater adherence to diabetes management activities.
Time frame: Assessed at baseline (T0), three months post-intervention (T2), and at six-month follow-up (T3)
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