Diabete Type 1InteduNCT07639307
Interactive Educational Video for Paediatric Type 1 Diabetes
A study testing Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes) and Traditional Face-to-Face Education in people with Diabete Type 1 and Educational Videos, run by G. d'Annunzio University.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 14 years
- Conditions the study is for
- Diabete Type 1, Educational Videos
- What is being tested?
- Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes) and Traditional Face-to-Face Education
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Efficacy of Interactive Videos in the Education of Paediatric Patients With Type 1 Diabetes: A Randomised Controlled 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.
Read more
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
- Being tested
- Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes), Traditional Face-to-Face Education
- Keywords
- Diabete Type 1, Educational Videos, metabolic control, Glycemic Control, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 EducationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Traditional Face-to-Face Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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%.
Measured: 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.
Measured: Assessed at baseline (T0), three months post-intervention (T2), and at six-month follow-up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valentina Simonetti, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639307
- Sponsor's protocol ID
- Interactive video
- Acronym
- Intedu
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Interactive Videos in the Education of Paediatric Patients With Type 1 Diabetes: A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT07639307
- Acronym / sponsor ID
- Intedu / Interactive video
- Conditions
- Diabete Type 1, Educational Videos
- Keywords
- Diabete Type 1, Educational Videos, metabolic control, Glycemic Control, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Educational Video | Experimental | Other: Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes)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. |
| Traditional face-to-face education | Active comparator | Other: Traditional Face-to-Face EducationParticipants 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. |
Who may qualify
- Ages
- 8 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes)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. | Other | Interactive Educational Video |
| Traditional Face-to-Face EducationThe 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. | Other | Traditional face-to-face education |
Primary outcome
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.
9 secondary outcomes
Change in Fasting Blood Glucose (FBS) levels from baseline to 6-month follow-up
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
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
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
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
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
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
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
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
Time frame: Assessed at baseline (T0), three months post-intervention (T2), and at six-month follow-up (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Diabete Type 1
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Diabetes Mellitus, Type 1
Not yet recruiting
Peer Support and Remote Patient Monitoring for Black Adults With Type 2 Diabetes
Type 2 Diabetes
Not yet recruiting
Role of Endothelial Dysfunction on Exercise Pressor Reflex in Type 2 Diabetes
Type 2 Diabetes (T2DM), Endothelial Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive Educational Video (Luca's Journey: Managing Type 1 Diabetes) and Traditional Face-to-Face Education in people with Diabete Type 1 and Educational Videos, run by G. d'Annunzio University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valentina Simonetti, Associate Professor (+39 (0871) 541205, v.simonetti@unich.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycated haemoglobin (HbA1c) levels from baseline to 6-month follow-up (time frame: Assessed at Baseline (T0) and 6 months (T3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.