13-18 YearNCT05811078
Metabolic Control Adolescents Type 1 Diabetes
A study testing training sessions with peer interactive group in people with 13-18 Year and Diagnosed at Least 6 Months Ago, run by Toros University at 1 site in Turkey (Türkiye).
Trial 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 more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- 13-18 Year, Diagnosed at Least 6 Months Ago, HbA1C> 7.5
- What is being tested?
- training sessions with peer interactive group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2023to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- - Using an insulin pump
- Having a chronic disease other than diabetes,
- Diseases that affect cognitive functions, hearing and vision impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Education Including Peer Interactive Group Support on Metabolic Control ın Adolescents wıth Type One Diabetes a Randomized Controlled Study
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.
- Being tested
- training sessions with peer interactive group
- Keywords
- Type 1 diabetes, metabolic control, adolescence, nursing
- 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.
training sessions with peer interactive groupBehavioural
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" .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start15 Apr 2023
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 13-18 YearStudies 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
- Crossover
- Model description
- randomized controlling trail
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toros University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Didem Polat Kulcu, Toros University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811078
- Sponsor's protocol ID
- TorosU
- Status last verified
- May 2025
- First submitted
- 7 Oct 2022
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: may be shared upon reasonable request from the author
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education Including Peer Interactive Group Support on Metabolic Control ın Adolescents wıth Type One Diabetes a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05811078
- Acronym / sponsor ID
- TorosU
- Keywords
- Type 1 diabetes, metabolic control, adolescence, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Toros UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 13 Apr 2023 (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.
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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized controlling trail
| Arm | Type | Receives |
|---|---|---|
| Enterprise Group | Experimental | Behavioral: training sessions with peer interactive groupThe 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. |
| 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. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- - Using an insulin pump
- Having a chronic disease other than diabetes,
- Diseases that affect cognitive functions, hearing and vision impairments
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 |
|---|---|---|
| training sessions with peer interactive groupData 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" . | Behavioural | Enterprise Group |
Primary outcome
Implementation of trainings containing peer interactive group support to adolescents and application of scales
Time frame: 7 weeks
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.
1 secondary outcome
Evaluation of Data
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: Yes. may be shared upon reasonable request from the author
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing training sessions with peer interactive group in people with 13-18 Year and Diagnosed at Least 6 Months Ago, run by Toros University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Implementation of trainings containing peer interactive group support to adolescents and application of scales (time frame: 7 weeks). 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 11 May 2025.