Type1diabetesNCT05737654
The Effect of Exercise on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life
A study testing Exercise with augmented reality glasses in people with Type1diabetes and Metabolic Syndrome, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Glasses (AR) on metabolic parameters, anthropometric measurement values and quality of life in children with T1DM aged 10-12 years. Read more about this study
- Who is it for?
- Ages 10 to 12 years
- Conditions the study is for
- Type1diabetes, Metabolic Syndrome, Nursing Caries
- What is being tested?
- Exercise with augmented reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 1 Jun 2024
- 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 10 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Those between the ages of 10-12,
- Having been diagnosed with Type 1 Diabetes (T1DM) at least six months ago,
- Do not have any other chronic disease other than T1DM,
- No psychiatric diagnosis
- No orthopedic problems,
- Able to read and write
Show all 10Show fewer
- Can speak Turkish,
- No mental, physical or neurological disability,
- residing in the province where the research will be conducted,
- Children and children with parental consent to participate in the study will be included in the study.
Who cannot join
- Not showing up on one of the planned workout days,
- Developing unexpected complications (hypoglycemia, hyperglycemia, diabetic ketoacidosis…) during exercise,
- Using another exercise method during the research process,
- Serum and urine biochemistry values cannot be measured,
- Anthropometric measurement values cannot be obtained,
- Have not had their main meal at least three hours before the scheduled exercise time,
- Children who do not have snacks and additional insulin on the planned exercise day will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Exercise with Augmented Reality Glasses on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life in Children Aged 10-12 with Type 1 Diabetes
This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Glasses (AR) on metabolic parameters, anthropometric measurement values and quality of life in children with T1DM aged 10-12 years. The research will be carried out with children aged 10-12 with T1DM who are followed up in Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital Pediatric Endocrinology Outpatient Clinic. A total of 30 (AR exercise group=15 and control group=15) children with T1DM between the ages of 10-12 will be included in the sample of the study, according to the sampling calculation. The data of the study, Descriptive Characteristics Form for Children with T1DM and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Quality of Life Scale for Children with Diabetes Mellitus Child and Parent Form (PedsQL 3.0), Augmented Reality Glasses, Continuous Glucose Tracker, Blood Glucose Meter, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Meter. Ethics committee approval from "Erciyes University Clinical Research Ethics Committee" and institutional permission from "ERU Health Application and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital" were obtained in order to conduct the study. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study; Exercise practice with augmented reality glasses is expected to improve metabolic parameters and anthropometric measurement values and increase the quality of life in children with T1DM.
The main question it aims to answer are:
Read more
Exercise with augmented reality glasses in children with T1DM;
- It has an effect on metabolic parameters.
- It has an effect on anthropometric measurement values.
- It has an effect on the scores of the Quality of Life in Children with Diabetes Mellitus Scale-Child and Parent Form (PedsQL 3.0).
Read the detailed description
Type 1 Diabetes Mellitus (T1DM) is a chronic metabolic disease characterized by insulin deficiency. T1DM is one of the most common chronic diseases in childhood. In the 10th Diabetes Atlas (2021) data of the International Diabetes Association (IDF), it is stated that the population of children aged 19 and under is 2.61 billion in the world, approximately 1.2 million of these children have T1DM, and there are approximately 150 thousand new children diagnosed with T1DM every year in the world. In the same report, it was stated that there are approximately 26 thousand children aged 19 and under with T1DM in Turkey. T1DM, whose treatment and management is complex, causes both children and their parents to encounter many problems. These problems cause deterioration in quality of life and perceived well-being in children with T1DM. The problems experienced in this direction, adaptation problems and decreased quality of life lead to deterioration of metabolic control in children with T1DM. Children with T1DM who cannot adapt to their disease may have acute and chronic complications that lead to deterioration of metabolic control. One of the most important complications seen in children with T1DM is osteopenia, which tends to increase gradually. Proper nutrition, physical activity, insulin therapy and follow-up of complications have an important place in preventing complications that may develop in children with T1DM, ensuring metabolic control and increasing their quality of life. Exercise in T1DM; reducing the need for insulin and increasing its effect, providing blood glucose control, increasing muscle strength, providing weight control, increasing body fat and muscle mass, increasing body fluid ratio, increasing bone mineralization, positively affecting the cardiovascular system, reducing blood fats, increasing self-conditioning, It provides many benefits such as increasing confidence and reducing stress. Despite the numerous benefits of exercise, studies have shown that children with T1DM do not exercise regularly and do not want to do traditional (walking, running, cycling, swimming, etc.) exercises. In this direction, exercise that requires continuity in diabetes management can be made dynamic for children with T1DM by using different approaches. For this reason, it is thought that structured exercise with augmented reality glasses (AR) that can respond to the reactions of the child with T1DM will be more dynamic and will prevent macrovascular complications such as osteopenia and increase the quality of life in children with T1DM by providing metabolic control.
- Conditions
- Type1diabetes, Metabolic Syndrome, Nursing Caries
- Being tested
- Exercise with augmented reality glasses
- Keywords
- Child with Type 1 Diabetes, Metabolic Parameters, Augmented Reality Glasses, Quality of Life, Anthropometric Values
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with augmented reality glassesOther
Two days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses.
| Study group | Role | What they receive |
|---|---|---|
| Augmented reality glasses group | Experimental | Two days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses. Receives: Other: Exercise with augmented reality glasses |
| Control group | No intervention | No intervention/application will be made to the children who will be included in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels
HbA1c levels of children with type 1 diabetes before, during, after exercise and during the control session.
Measured: Change in average HbA1c levels over 12-week sessions
Change in body mass index
Average body mass index values of children with type 1 diabetes before, during, after exercise and during the control session.
Measured: Change in average body mass index over 12-week sessions
Change in quality of life
Quality of life scale in children with Type 1 Diabetes Mellitus (PedsQL 3.0) Varni et al. (2003) developed by This scale measures both general areas of quality of life and disease-specific areas. The scale is a comprehensive, multidimensional scale made with both diabetic children and surrogate (parent/caregiver) notifications. In the scale prepared according to the five-point Likert system, 0 = never creates a problem, 1 = almost never creates a problem, 2 = sometimes creates a problem, 3 = often creates a problem, and 4 = always poses a problem. A linear translation is applied in the total score calculation of the scale and it turns into 0-100 points. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The higher the total score, the better the perceived health-related quality of life.
Measured: Change in average quality of life values over 12-week sessions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start1 Oct 2023
- Primary completion1 Jan 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harun Özbey, TC Erciyes University
- Investigators
- Meral Bayat, PhD, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737654
- Sponsor's protocol ID
- 2022/540
- Status last verified
- Dec 2023
- First submitted
- 23 Jan 2023
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozbey H, Bayat M. The effect of exercise with augmented reality glasses on metabolic parameters, anthropometric measurement values and quality of life in children aged 10-12 with type 1 diabetes: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:239-248. doi: 10.1016/j.pedn.2025.08.002. Epub 2025 Aug 7.
PubMed 40780014
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Exercise with Augmented Reality Glasses on Metabolic Parameters, Anthropometric Measurement Values and Quality of Life in Children Aged 10-12 with Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05737654
- Acronym / sponsor ID
- 2022/540
- Conditions
- Type1diabetes, Metabolic Syndrome, Nursing Caries
- Keywords
- Child with Type 1 Diabetes, Metabolic Parameters, Augmented Reality Glasses, Quality of Life, Anthropometric Values
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 21 Feb 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.
This study was planned as a randomized controlled experimental study to determine the effect of exercise with Augmented Reality Glasses (AR) on metabolic parameters, anthropometric measurement values and quality of life in children with T1DM aged 10-12 years. The research will be carried out with children aged 10-12 with T1DM who are followed up in Erciyes University Health Application and Research Center Fevzi Mercan-Mustafa Eraslan Children's Hospital Pediatric Endocrinology Outpatient Clinic. A total of 30 (AR exercise group=15 and control group=15) children with T1DM between the ages of 10-12 will be included in the sample of the study, according to the sampling calculation. The data of the study, Descriptive Characteristics Form for Children with T1DM and Their Families, Serum and Urine Biochemistry Values Form, Anthropometric Measurement Values Form, Quality of Life Scale for Children with Diabetes Mellitus Child and Parent Form (PedsQL 3.0), Augmented Reality Glasses, Continuous Glucose Tracker, Blood Glucose Meter, Body Composition Analyzer, Caliper, Tape Measure and Digital Height and Weight Meter. Ethics committee approval from "Erciyes University Clinical Research Ethics Committee" and institutional permission from "ERU Health Application and Research Center Mustafa Eraslan Fevzi Mercan Children's Hospital" were obtained in order to conduct the study. Hypothesis tests, correlation and regression analyzes will be applied according to the suitability of the data for normal distribution. As a result of the study; Exercise practice with augmented reality glasses is expected to improve metabolic parameters and anthropometric measurement values and increase the quality of life in children with T1DM.
The main question it aims to answer are:
Exercise with augmented reality glasses in children with T1DM;
- It has an effect on metabolic parameters.
- It has an effect on anthropometric measurement values.
- It has an effect on the scores of the Quality of Life in Children with Diabetes Mellitus Scale-Child and Parent Form (PedsQL 3.0).
Detailed description
Type 1 Diabetes Mellitus (T1DM) is a chronic metabolic disease characterized by insulin deficiency. T1DM is one of the most common chronic diseases in childhood. In the 10th Diabetes Atlas (2021) data of the International Diabetes Association (IDF), it is stated that the population of children aged 19 and under is 2.61 billion in the world, approximately 1.2 million of these children have T1DM, and there are approximately 150 thousand new children diagnosed with T1DM every year in the world. In the same report, it was stated that there are approximately 26 thousand children aged 19 and under with T1DM in Turkey. T1DM, whose treatment and management is complex, causes both children and their parents to encounter many problems. These problems cause deterioration in quality of life and perceived well-being in children with T1DM. The problems experienced in this direction, adaptation problems and decreased quality of life lead to deterioration of metabolic control in children with T1DM. Children with T1DM who cannot adapt to their disease may have acute and chronic complications that lead to deterioration of metabolic control. One of the most important complications seen in children with T1DM is osteopenia, which tends to increase gradually. Proper nutrition, physical activity, insulin therapy and follow-up of complications have an important place in preventing complications that may develop in children with T1DM, ensuring metabolic control and increasing their quality of life. Exercise in T1DM; reducing the need for insulin and increasing its effect, providing blood glucose control, increasing muscle strength, providing weight control, increasing body fat and muscle mass, increasing body fluid ratio, increasing bone mineralization, positively affecting the cardiovascular system, reducing blood fats, increasing self-conditioning, It provides many benefits such as increasing confidence and reducing stress. Despite the numerous benefits of exercise, studies have shown that children with T1DM do not exercise regularly and do not want to do traditional (walking, running, cycling, swimming, etc.) exercises. In this direction, exercise that requires continuity in diabetes management can be made dynamic for children with T1DM by using different approaches. For this reason, it is thought that structured exercise with augmented reality glasses (AR) that can respond to the reactions of the child with T1DM will be more dynamic and will prevent macrovascular complications such as osteopenia and increase the quality of life in children with T1DM by providing metabolic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented reality glasses group | Experimental | Other: Exercise with augmented reality glassesTwo days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses. |
| Control group | No intervention | –No intervention/application will be made to the children who will be included in the control group. |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Those between the ages of 10-12,
- Having been diagnosed with Type 1 Diabetes (T1DM) at least six months ago,
- Do not have any other chronic disease other than T1DM,
- No psychiatric diagnosis
- No orthopedic problems,
Key exclusion criteria (7 listed)
- Not showing up on one of the planned workout days,
- Developing unexpected complications (hypoglycemia, hyperglycemia, diabetic ketoacidosis…) during exercise,
- Using another exercise method during the research process,
- Serum and urine biochemistry values cannot be measured,
- Anthropometric measurement values cannot be obtained,
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 |
|---|---|---|
| Exercise with augmented reality glassesTwo days a week (12 weeks in total), each session will be 60 minutes in total, and moderate exercise will be done with AR glasses. | Other | Augmented reality glasses group |
Primary outcome
Change in HbA1c levels
Time frame: Change in average HbA1c levels over 12-week sessions
HbA1c levels of children with type 1 diabetes before, during, after exercise and during the control session.
Change in body mass index
Time frame: Change in average body mass index over 12-week sessions
Average body mass index values of children with type 1 diabetes before, during, after exercise and during the control session.
Change in quality of life
Time frame: Change in average quality of life values over 12-week sessions
Quality of life scale in children with Type 1 Diabetes Mellitus (PedsQL 3.0) Varni et al. (2003) developed by This scale measures both general areas of quality of life and disease-specific areas. The scale is a comprehensive, multidimensional scale made with both diabetic children and surrogate (parent/caregiver) notifications. In the scale prepared according to the five-point Likert system, 0 = never creates a problem, 1 = almost never creates a problem, 2 = sometimes creates a problem, 3 = often creates a problem, and 4 = always poses a problem. A linear translation is applied in the total score calculation of the scale and it turns into 0-100 points. The answer to the question is scored 100 if it is marked as never, 75 if it is marked as rarely, 50 if it is marked as sometimes, 25 if it is marked as often, and 0 if it is marked as almost always. The higher the total score, the better the perceived health-related quality of life.
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 10 Dec 2024.
- Derived from this study: PubMed 40780014Ozbey H, Bayat M. The effect of exercise with augmented reality glasses on metabolic parameters, anthropometric measurement values and quality of life in children aged 10-12 with type 1 diabetes: A randomized controlled trial. J Pediatr Nurs. 2025 Nov-Dec;85:239-248. doi: 10.1016/j.pedn.2025.08.002. Epub 2025 Aug 7.
- Individual participant dataSharing planned: No
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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.
Meral Bayat, PhD principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with augmented reality glasses in people with Type1diabetes and Metabolic Syndrome, run by TC Erciyes 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 10 inclusion and 7 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 10 Dec 2024. 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?
Change in HbA1c levels (time frame: Change in average HbA1c levels over 12-week sessions). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05737654, which also lists 1 linked publication.
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 10 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.