NCT07148076

Brief 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. 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 29, 2025

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

11 months

First QC Date

August 22, 2025

Last Update Submit

August 29, 2025

Conditions

Keywords

Type 1 Diabetes, Children, Educational Staff, Primary Schools,Kindergartens

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    Three months after completion of the educational program

Study Arms (2)

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.

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.

Interventions

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.

Intervention Group - Education Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Osnovna škola Tin Ujević, Dječji vrtići Smilje

Šibenik, Hrvatska, 22000, Croatia

Location

Osnovna škola Tin Ujević, Dječji vrtići Smilje, Šibenik, Hrvatska 22000

Šibenik, Šibenik, 22000, Croatia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Lecturer, MSN

Study Record Dates

First Submitted

August 22, 2025

First Posted

August 29, 2025

Study Start

October 1, 2024

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

September 8, 2025

Record last verified: 2025-08

Locations