Type 1 Diabetes (T1D)PKA-T1D-EDUNCT07148076
"Perception, Knowledge, and Attitudes of Educational Staff Regarding the Care of Children With Type 1 Diabetes: Evaluation of the Educational Program"
A study testing Education Program in people with Type 1 Diabetes (T1D), run by Sibenik University of Applied Sciences at 2 sites in Croatia.
Trial summary
Type 1 diabetes is a chronic autoimmune disease that requires continuous monitoring and regulation of glycemia. Children with type 1 diabetes face challenges that can disrupt their daily routines in school and kindergarten. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Education Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 Oct 2024to 1 Oct 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Educational staff employed in primary schools and/or kindergartens within the study area
- Individuals willing to participate who have provided informed consent
- Participants available for all planned assessments during the study period.
Who cannot join
- Educational staff who have type 1 diabetes themselves, to avoid bias in the assessment of knowledge, perceptions, and attitudes due to personal experience with the disease
- Educational staff who have close family members (parent, child, spouse, sibling) diagnosed with type 1 diabetes, as personal experiences and additional knowledge gained through family circumstances could affect the objectivity of the results
- Individuals unable to participate in all phases of the study (e.g., due to planned absence or other reasons)
- Individuals who are unwilling or unable to provide informed consent
- This description clearly defines who is eligible and who is excluded from participation, ensuring the representativeness and objectivity of the study sample.
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Osnovna škola Tin Ujević, Dječji vrtići Smilje
Šibenik, Hrvatska, 22000
Osnovna škola Tin Ujević, Dječji vrtići Smilje, Šibenik, Hrvatska 22000
Šibenik, Šibenik, 22000
About this study
Type 1 diabetes is a chronic autoimmune disease that requires continuous monitoring and regulation of glycemia. Children with type 1 diabetes face challenges that can disrupt their daily routines in school and kindergarten. This includes the need for self-monitoring, continuous blood sugar measurement, insulin administration, proper nutrition, regular physical activity, and timely interventions in cases of hypoglycemia or hyperglycemia. Therefore, children with diabetes often require support from educational staff, including teachers, preschool educators, and other professional personnel while attending educational institutions.
A safe and supportive (pre)school environment is crucial for maintaining the health and well-being of children with type 1 diabetes. Teachers and preschool educators, as key actors in the daily (pre)school life of the child, play an important role in recognizing disease symptoms and managing emergencies. However, research shows that many teachers lack sufficient knowledge about the symptoms of diabetes and the necessary procedures in emergencies, which can endanger the health and safety of the child, as well as their equal participation in educational activities.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Education Program
- Keywords
- Type 1 Diabetes, Children, Educational Staff, Primary Schools,Kindergartens
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education ProgramBehavioural
This intervention consists of a structured educational program specifically designed for educational staff in primary schools and kindergartens, focusing on the care of children with type 1 diabetes. The program includes interactive lectures, practical workshops, and case studies covering diabetes management, symptom recognition, emergency procedures, and day-to-day support for children with type 1 diabetes in educational settings. Unlike standard informational sessions or general health education, this intervention is tailored to address the unique challenges and responsibilities faced by school and kindergarten staff. The program is delivered in-person by certified diabetes educators and includes pre- and post-training assessments to measure changes in knowledge, perceptions, and attitudes. Participants are tracked using unique codes to allow for longitudinal comparison of results before, immediately after, and three months following the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Education Program | Experimental | Participants in the intervention group completed a baseline questionnaire assessing perceptions, knowledge, and attitudes about type 1 diabetes care. They then participated in an educational program specifically designed to improve these aspects. Immediately following the education, participants completed a second questionnaire. A third questionnaire was administered 3 months after the intervention to assess retention of knowledge and changes in attitudes and perceptions. Receives: Behavioral: Education Program |
| Control Group - No Intervention | No intervention | Participants in the control group did not receive any educational program or intervention. They completed the same questionnaire as the intervention group at baseline and again 3 months later. This allowed for comparison of changes in perceptions, knowledge, and attitudes about type 1 diabetes care without exposure to the educational intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes
Primary Outcome:
The primary outcome will be assessed by measuring the difference in the total score on a comprehensive, structured questionnaire designed to evaluate the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes. The questionnaire is administered before and immediately after participation in the educational program, as well as three months post-intervention. The objective is to quantify the immediate and sustained effects of the intervention on participants' understanding and preparedness to support children with type 1 diabetes in educational settings.
Time Frame:
Assessment will be conducted at three time points: prior to the start of the educational program (baseline) immediately after completion of the program.
Instrument:
The instrument used is a structured questionnaire specifically developed for this study. It is a compilation of seven previously validated instruments
Measured: Before the educational program Immediately after the educational program The entire study is scheduled to be conducted over a period of 10 months
Secondary outcomes (1)
Sustainability of Changes in Knowledge, Perception, and Attitudes
This outcome will assess the sustainability of changes in educational staff's knowledge, perceptions, and attitudes regarding the care of children with type 1 diabetes. The difference in total scores on the same structured questionnaire will be measured three months after the educational program, compared to both baseline and immediate post-intervention results. This analysis aims to determine whether the improvements observed immediately after the intervention are maintained over time, indicating lasting impact of the educational program on participants' competencies and attitudes.
Instrument:
The same structured questionnaire developed specifically for this study, which is a compilation of seven previously validated instruments covering all relevant aspects of diabetes care in educational settings. This tool has undergone expert review and pilot testing to ensure its validity and reliability within the target population.
Measured: Three months after completion of the educational program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Oct 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sibenik University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevena Simunic, Sibenik University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148076
- Sponsor's protocol ID
- SibenikU
- Acronym
- PKA-T1D-EDU
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Perception, Knowledge, and Attitudes of Educational Staff Regarding the Care of Children With Type 1 Diabetes: Evaluation of the Educational Program"
- ClinicalTrials.gov ID
- NCT07148076
- Acronym / sponsor ID
- PKA-T1D-EDU / SibenikU
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Type 1 Diabetes, Children, Educational Staff, Primary Schools,Kindergartens
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sibenik University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 29 Aug 2025 (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.
Type 1 diabetes is a chronic autoimmune disease that requires continuous monitoring and regulation of glycemia. Children with type 1 diabetes face challenges that can disrupt their daily routines in school and kindergarten. This includes the need for self-monitoring, continuous blood sugar measurement, insulin administration, proper nutrition, regular physical activity, and timely interventions in cases of hypoglycemia or hyperglycemia. Therefore, children with diabetes often require support from educational staff, including teachers, preschool educators, and other professional personnel while attending educational institutions.
A safe and supportive (pre)school environment is crucial for maintaining the health and well-being of children with type 1 diabetes. Teachers and preschool educators, as key actors in the daily (pre)school life of the child, play an important role in recognizing disease symptoms and managing emergencies. However, research shows that many teachers lack sufficient knowledge about the symptoms of diabetes and the necessary procedures in emergencies, which can endanger the health and safety of the child, as well as their equal participation in educational activities.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Education Program | Experimental | Behavioral: Education ProgramParticipants in the intervention group completed a baseline questionnaire assessing perceptions, knowledge, and attitudes about type 1 diabetes care. They then participated in an educational program specifically designed to improve these aspects. Immediately following the education, participants completed a second questionnaire. A third questionnaire was administered 3 months after the intervention to assess retention of knowledge and changes in attitudes and perceptions. |
| Control Group - No Intervention | No intervention | –Participants in the control group did not receive any educational program or intervention. They completed the same questionnaire as the intervention group at baseline and again 3 months later. This allowed for comparison of changes in perceptions, knowledge, and attitudes about type 1 diabetes care without exposure to the educational intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Educational staff employed in primary schools and/or kindergartens within the study area
- Individuals willing to participate who have provided informed consent
- Participants available for all planned assessments during the study period.
Key exclusion criteria (5 listed)
- Educational staff who have type 1 diabetes themselves, to avoid bias in the assessment of knowledge, perceptions, and attitudes due to personal experience with the disease
- Educational staff who have close family members (parent, child, spouse, sibling) diagnosed with type 1 diabetes, as personal experiences and additional knowledge gained through family circumstances could affect the objectivity of the results
- Individuals unable to participate in all phases of the study (e.g., due to planned absence or other reasons)
- Individuals who are unwilling or unable to provide informed consent
- This description clearly defines who is eligible and who is excluded from participation, ensuring the representativeness and objectivity of the study sample.
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 |
|---|---|---|
| Education ProgramThis intervention consists of a structured educational program specifically designed for educational staff in primary schools and kindergartens, focusing on the care of children with type 1 diabetes. The program includes interactive lectures, practical workshops, and case studies covering diabetes management, symptom recognition, emergency procedures, and day-to-day support for children with type 1 diabetes in educational settings. Unlike standard informational sessions or general health education, this intervention is tailored to address the unique challenges and responsibilities faced by school and kindergarten staff. The program is delivered in-person by certified diabetes educators and includes pre- and post-training assessments to measure changes in knowledge, perceptions, and attitudes. Participants are tracked using unique codes to allow for longitudinal comparison of results before, immediately after, and three months following the intervention. | Behavioural | Intervention Group - Education Program |
Primary outcome
Change in the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes
Time frame: Before the educational program Immediately after the educational program The entire study is scheduled to be conducted over a period of 10 months
Primary Outcome: The primary outcome will be assessed by measuring the difference in the total score on a comprehensive, structured questionnaire designed to evaluate the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes. The questionnaire is administered before and immediately after participation in the educational program, as well as three months post-intervention. The objective is to quantify the immediate and sustained effects of the intervention on participants' understanding and preparedness to support children with type 1 diabetes in educational settings. Time Frame: Assessment will be conducted at three time points: prior to the start of the educational program (baseline) immediately after completion of the program. Instrument: The instrument used is a structured questionnaire specifically developed for this study. It is a compilation of seven previously validated instruments
1 secondary outcome
Sustainability of Changes in Knowledge, Perception, and Attitudes
Time frame: Three months after completion of the educational program
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 8 Sep 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Type 1 Diabetes (T1D)
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Active, not recruitingPhase 4
Diabetes in African Youth
type1diabetes
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education Program in people with Type 1 Diabetes (T1D), run by Sibenik University of Applied Sciences at 2 sites in Croatia.
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 3 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the perception, knowledge, and attitudes of educational staff regarding the care of children with type 1 diabetes (time frame: Before the educational program Immediately after the educational program The entire study is scheduled to be conducted over a period of 10 months). 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 8 Sep 2025.