Metabolic Control Adolescents Type 1 Diabetes

NCT05811078 | Completed DMC

• 1 other identifier: TorosU
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  7 weeks

Secondary Outcomes (1)

• Evaluation of Data

  one year

Study Arms (2)

Enterprise Group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

training sessions with peer interactive group BEHAVIORAL

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" .

Enterprise Group

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Toros University: lead

Study Sites (1)

Toros Üniversty

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Adolescents who met the inclusion criteria of the study were listed and their names were written to someone who was not involved in the study. The adolescents included in the list formed by this person who was excluded from the study were randomly assigned to the experimental and control groups according to the block randomization method in order to eliminate the selection bias and to ensure the balance in the number of individuals between the groups. From here, all possible possibilities were created and the blocks were arranged so that there were 4 individuals (2 experiments, 2 controls) in each block. Each block was given a number and the assignment was made using the https://www.randomizer.org/ address.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle ınvestigator

Model Details: randomized controlling trail

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: April 13, 2023
• Study Start: April 15, 2023
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2024
• Access Criteria: may be shared upon reasonable request from the author

Locations

TU (1)