Not Yet RecruitingNot Applicable

Interactive Educational Video for Paediatric Type 1 Diabetes

110 participantsStarted 2027-01

Plain-language 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.

Who can participate

Age range

8 Years – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial uses interactive educational videos to help manage Type 1 diabetes in children — can you explain how watching videos is expected to actually improve HbA1c levels over 6 months, and what the evidence behind that approach looks like so far?
2Since this trial is listed as 'not yet recruiting,' how long do you think it might realistically be before it opens, and would waiting for it delay any other treatment or management steps my child should be starting now?
3The trial is listed as Phase N/A, which I understand often means it's more of a behavioural or educational study rather than a drug trial — does that mean the safety risks are lower, and are there any risks at all we should still think about?
4How does the educational video approach in this trial compare to the diabetes education and support my child would receive through standard care, so we can weigh whether joining would actually add something meaningfully different?
5If my child were to take part, what would the 6-month commitment look like practically — how often would we need to come in, what would my child be asked to do, and is that realistic given our current schedule?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Trial details

NCT IDNCT07639307

SponsorG. d'Annunzio University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Valentina Simonetti, Associate Professor

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

View on ClinicalTrials.gov More Diabete Type 1 trials