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CompletedNCT05811078Updated May 11, 2025

Metabolic Control Adolescents Type 1 Diabetes

An interventional study of training sessions with peer interactive group in 13-18 Year, Diagnosed at Least 6 Months Ago and HbA1C> 7.5, sponsored by Toros University. Completed at 1 site in Turkey. Open to participants aged 13 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-05-11.

Sponsored by Toros University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
13 Years to 18 Years
Sex
All
01

Study summary

Purpose of the research; The aim of this study is to examine the effect of education including peer-interactive group support to be given to adolescents diagnosed with Type 1 diabetes with poor glycemic control in the 13-18 age group on metabolic control of adolescents.

Read the detailed description

The lack of a certificate program specific to pediatric diabetes nursing of the Ministry of Health in our country and the insufficient number of diabetes education nurses show that the pediatric population is not adequately trained to provide diabetes management. Along with these obstacles, the lack of use of an evidence-based standard education program reveals the need for effective intervention programs that include approaches specific to adolescents, who are a particularly risky group. Peer interaction can be used as an effective approach to increase adolescents' adherence to treatment. Thus, adolescents who isolate themselves are given the opportunity to cope with the disease and to share with other children. It has been determined that there is no study in the literature that includes peer-interactive group support on adolescents with a diagnosis of Type 1 diabetes who have poor glycemic control but have repeated hospitalizations. This situation shows that there is a need for a study to evaluate the effect of educational intervention including peer-interactive group support on repeated hospitalizations in adolescents with Type 1 diabetes.

02

Conditions studied

  • 13-18 Year
  • Diagnosed at Least 6 Months Ago
  • HbA1C> 7.5
  • Being Able to Read and Write

Keywords

  • Type 1 diabetes
  • metabolic control
  • adolescence
  • nursing
03

In context

Lead sponsor

Toros University is the lead sponsor of 20 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • be between 13-18 years old
  • Diagnosed at least 6 months ago
  • HbA1C level > 7.5
  • Having repeated hospitalizations at least twice
  • Living in Mersin city center
  • Being able to communicate in Turkish
  • Being able to read and write

Exclusion criteria

Exclusion Criteria:

    • Using an insulin pump
  • Having a chronic disease other than diabetes,
  • Diseases that affect cognitive functions, hearing and vision impairments
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Enterprise Group

    The contents of the research were created according to the Roy Adaptation model. Each session lasted an average of 2 hours. Peer interactive group support sessions were administered to the adolescents in the intervention group, one week apart. There were 7 sessions in total. The sitting arrangement of the training room is designed to allow children to interact with each other . The sessions lasted an average of 90 minutes as two 45-minute sessions. Between sessions, breaks that lasted for about 15 minutes were given and refreshments prepared for individuals with Type 1 diabetes were served during the breaks. During the break, the adolescents were given the opportunity to interact with each other by chatting. Fun exercise and kitchen workshop activities were also organized as interaction sessions in the initiative group.

    Behavioral: training sessions with peer interactive group

  • No intervention
    Control Group

    Adolescents and their families were informed in the diabetes education room in the pediatric endocrine service of the hospital where the study was conducted, and their written consent was obtained. Within the scope of the pre-test, "Diabetes Adolescent Diagnosis Form", "Diabetes Information Evaluation Form", "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes" and "Child's Attitude towards Own Disease Scale" were applied. Then, individual diabetes education was given by the diabetes education nurse as a hospital routine. Three months after the training, the adolescents were called by phone to the hospital for control, HbA1c follow-up was taken and post-test applications were made.

Interventions

  • Behavioraltraining sessions with peer interactive group

    Data were collected with data collection forms consisting of " Diabetes Adolescent Diagnosis Form", "Diabetes Information Evaluation Form", "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes" and "Child's Attitude towards Own Disease Scale" .

06

What researchers measure

Primary outcomes

  1. Implementation of trainings containing peer interactive group support to adolescents and application of scales

    The contents of the research were created according to the Roy Adaptation model. Each session lasted an average of 2 hours. Peer interactive group support sessions were administered to the adolescents in the intervention group, one week apart. There were 7 sessions in total. The sessions lasted an average of 90 minutes as two 45-minute sessions. Between sessions, breaks that lasted for about 15 minutes were given and refreshments prepared for individuals with Type 1 diabetes were served during the breaks. During the break, the adolescents were given the opportunity to interact with each other by chatting. Fun exercise and kitchen workshop activities were also organized as interaction sessions in the initiative group.

    Time frame: 7 weeks

Secondary outcomes

  1. Evaluation of Data

    The data obtained from the research were evaluated using appropriate statistical methods. In the analysis of comparative data, parametric or nonparametric tests were used by evaluating the conformity to the normal distribution . As descriptive statistics; numbers and percentages are given. In addition, mean and standard deviation values are given for those with normal distribution, and minimum and maximum values, median and percentiles of 25-75 % for those who do not show normal distribution.

    Time frame: one year

07

Study locations

1 site
  • Toros Üniversty
    Mersin, Turkey
08

References and documents

Individual participant data

Plan to share: Yes — may be shared upon reasonable request from the author

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05811078
Lead sponsor
Toros University
Responsible party
Didem Polat Kulcu (principle ınvestigator, Toros University) — Principal investigator
First posted
Apr 13, 2023
Start date
Apr 15, 2023
Primary completion
Jul 15, 2023
Completion
Jul 15, 2023
Last update
May 11, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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