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NCT Number: NCT07639307

Interactive Educational Video for Paediatric Type 1 Diabetes

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.

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Key information

Conditions

Diabete Type 1 Educational Videos

Age range

8 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Assessed at Baseline (T0) and 6 months (T3).

    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.

Secondary outcomes

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

    Time frame: Assessed at baseline (T0) and 6 months (T3)

    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.

  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

    Time frame: Assessed at baseline (T0) and 6 months (T3)

    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).

  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

    Time frame: Assessed at baseline (T0) and 6 months (T3)

    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)

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

    Time frame: Assessed at baseline (T0) and 6 months (T3)

    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.

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

    Time frame: Assessed at baseline (T0) and 6 months (T3)

    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.

  6. Change in Body Mass Index (BMI) Calculated From Height and Weight Measurements From Baseline to 6-Month Follow-up

    Time frame: Assessed at baseline (T0) and at six-month follow-up (T3)

    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.

  7. Change in Waist Circumference Assessed by Standard Tape Measure From Baseline to 6-Month Follow-up

    Time frame: Assessed at baseline (T0) and at six-month follow-up (T3)

    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).

  8. Change in Nutritional Knowledge Assessed by the Nutrition Knowledge Survey (NKS) From Baseline to 6-Month Follow-up

    Time frame: Assessed at baseline (T0), immediately post-intervention (T1), three months post-intervention (T2), and at six-month follow-up (T3).

    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%.

  9. Change in Adherence to Diabetes Management Activities Assessed by the Diabetes Management Questionnaire (DMQ) From Baseline to 6-Month Follow-up

    Time frame: Assessed at baseline (T0), three months post-intervention (T2), and at six-month follow-up (T3)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Valentina Simonetti, Associate Professor

CONTACT

[email protected]

+39 (0871) 541205

Sponsors and collaborators

Lead sponsor

G. d'Annunzio University

Other

Registry information

Official study title

The Efficacy of Interactive Videos in the Education of Paediatric Patients With Type 1 Diabetes: A Randomised Controlled Trial.

Acronym: Intedu

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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