Children and Adolescents With Type 1 Diabetes MellitusNCT05666791
The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
An observational study of Children and Adolescents With Type 1 Diabetes Mellitus, run by National Taiwan University Hospital.
Trial summary
The aims of this study were to: (1) Investigate the association between perceived diabetes-specific stress, self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D). Read more about this study
- Who is it for?
- Ages 8 to 25 years
- Conditions the study is for
- Children and Adolescents With Type 1 Diabetes Mellitus
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 21 Dec 2022to Dec 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 8 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with type 1 diabetes mellitus being treated at NTUH will be recruited. The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8~25 years old, and also being able to read or communicate verbally in mandarin Chinese.
Who may be able to join
- The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8~25 years old, and also being able to read or communicate verbally in mandarin Chinese.
Who cannot join
- Participants diagnosed with cognitive or mental health problems were excluded.
Trial locations and contacts
No sites are listed yet.
About this study
The aims of this study were to: (1) Investigate the association between perceived diabetes-specific stress, self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D). (2) Explore whether self-efficacy and self-management mediates the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D). (3) Explore whether self-efficacy and self-management moderated the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D).
Read the detailed description
Investigators have found that type 1 diabetes mellitus (T1D) is more commonly diagnosed in childhood compared with adulthood; optimizing HbA1c level is essential for reducing the risk and severity of complications; childhood glycemic control is also associated with further risk of physical and psychological health problems as an adult, nevertheless, adolescence is a stage of transition to adulthood, compared with other age groups, and adolescents with type 1 diabetes mellitus (T1D) have worse glycemic control.
Diabetes-specific stress has been previously defined as a negative experience involving physiological, emotional, and behavior changes in relation to a diabetes specific stressor, it is also associated with psychological well-being and mediates the relationship between diabetes-specific cognitive appraisals and glycemic control.
Cross-sectional studies also indicate that self-efficacy and self-management are positively correlated, importantly, in adolescents with type 1 diabetes mellitus (T1D), higher self-efficacy was associated with lower HbA1c levels; higher self-efficacy was also directly associated with better self-management and lower HbA1c levels.
Individuals with type 1 diabetes mellitus (T1D) need to self-manage their HbA1c levels throughout their lives, self-management also refers to the daily active management of illness-related activities for achieving glycemic control; accordingly, self-management in adolescents is always challenging, and glycemic control is typically at its worst in the transitional period between adolescence and adulthood.
Considering that diabetes-specific stress might be directly associated with self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D), further study is still warranted. Understanding the factors and pathways associated with subsequent HbA1c levels could assist in the development of comprehensive and timely interventions to improve glycemic control among this population.
This study applied as a cross-sectional study; Demographic characteristics, Diabetes-specific stress, self -efficacy and self-management were collected using self -reported questionnaires; HbA1c levels will be obtained from medical records.
- Keywords
- Children and adolescents with type 1 diabetes mellitus, Diabetes stress, Self-efficacy, Self-management, HbA1c
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographic characteristics
Demographic characteristics include participants' age, gender, diabetes treatment plan, body high and body weight; caregiver's age, income, education background, occupation and health condition.
Measured: 5 minutes
Diabetes specific-stress
The 24-item Diabetes Stress Questionnaire-short form (DSQ-SF) demonstrated good internal consistency and convergent validity; it's also a quick, cost-effective and useful tool for measuring perceived stress in youth with type 1 diabetes mellitus; higher scores indicating higher levels of diabetes specific-stress.
Measured: 10 minutes
Self-management
The 23-item Short Form Chinese version of the Self-Management of Type 1 Diabetes for Adolescents Scale (C-SMOD-A-23) was used to assess patient collaboration with parents; patient diabetes care activities, problem-solving behaviors and communication, and healthy lifestyle goals; the higher the item mean score, the greater the patient's self-management ability.
Measured: 10 minutes
Self-efficacy
The 10-item Chinese version of the self-efficacy scale was used to measure self-confidence in facing potential challenges in diabetes self-management in children and adolescents with Type 1 Diabetes; the higher the item mean score, the higher the patient's self-efficacy.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start21 Dec 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children and Adolescents With Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666791
- Sponsor's protocol ID
- 202210117RINC
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05666791
- Acronym / sponsor ID
- 202210117RINC
- Keywords
- Children and adolescents with type 1 diabetes mellitus, Diabetes stress, Self-efficacy, Self-management, HbA1c
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 21 Dec 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Dec 2022 (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.
The aims of this study were to: (1) Investigate the association between perceived diabetes-specific stress, self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D). (2) Explore whether self-efficacy and self-management mediates the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D). (3) Explore whether self-efficacy and self-management moderated the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D).
Detailed description
Investigators have found that type 1 diabetes mellitus (T1D) is more commonly diagnosed in childhood compared with adulthood; optimizing HbA1c level is essential for reducing the risk and severity of complications; childhood glycemic control is also associated with further risk of physical and psychological health problems as an adult, nevertheless, adolescence is a stage of transition to adulthood, compared with other age groups, and adolescents with type 1 diabetes mellitus (T1D) have worse glycemic control.
Diabetes-specific stress has been previously defined as a negative experience involving physiological, emotional, and behavior changes in relation to a diabetes specific stressor, it is also associated with psychological well-being and mediates the relationship between diabetes-specific cognitive appraisals and glycemic control.
Cross-sectional studies also indicate that self-efficacy and self-management are positively correlated, importantly, in adolescents with type 1 diabetes mellitus (T1D), higher self-efficacy was associated with lower HbA1c levels; higher self-efficacy was also directly associated with better self-management and lower HbA1c levels.
Individuals with type 1 diabetes mellitus (T1D) need to self-manage their HbA1c levels throughout their lives, self-management also refers to the daily active management of illness-related activities for achieving glycemic control; accordingly, self-management in adolescents is always challenging, and glycemic control is typically at its worst in the transitional period between adolescence and adulthood.
Considering that diabetes-specific stress might be directly associated with self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D), further study is still warranted. Understanding the factors and pathways associated with subsequent HbA1c levels could assist in the development of comprehensive and timely interventions to improve glycemic control among this population.
This study applied as a cross-sectional study; Demographic characteristics, Diabetes-specific stress, self -efficacy and self-management were collected using self -reported questionnaires; HbA1c levels will be obtained from medical records.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 8 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with type 1 diabetes mellitus being treated at NTUH will be recruited. The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8~25 years old, and also being able to read or communicate verbally in mandarin Chinese.
Key inclusion criteria (1 listed)
- The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8~25 years old, and also being able to read or communicate verbally in mandarin Chinese.
Key exclusion criteria (1 listed)
- Participants diagnosed with cognitive or mental health problems were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Demographic characteristics
Time frame: 5 minutes
Demographic characteristics include participants' age, gender, diabetes treatment plan, body high and body weight; caregiver's age, income, education background, occupation and health condition.
Diabetes specific-stress
Time frame: 10 minutes
The 24-item Diabetes Stress Questionnaire-short form (DSQ-SF) demonstrated good internal consistency and convergent validity; it's also a quick, cost-effective and useful tool for measuring perceived stress in youth with type 1 diabetes mellitus; higher scores indicating higher levels of diabetes specific-stress.
Self-management
Time frame: 10 minutes
The 23-item Short Form Chinese version of the Self-Management of Type 1 Diabetes for Adolescents Scale (C-SMOD-A-23) was used to assess patient collaboration with parents; patient diabetes care activities, problem-solving behaviors and communication, and healthy lifestyle goals; the higher the item mean score, the greater the patient's self-management ability.
Self-efficacy
Time frame: 5 minutes
The 10-item Chinese version of the self-efficacy scale was used to measure self-confidence in facing potential challenges in diabetes self-management in children and adolescents with Type 1 Diabetes; the higher the item mean score, the higher the patient's self-efficacy.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Children and Adolescents With Type 1 Diabetes Mellitus, run by National Taiwan University Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hsin-Yi Wang, master's student (+8862 2312-3456 ext. 261057, hsinyiwang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographic characteristics (time frame: 5 minutes). The study lists 4 primary outcomes in all. 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 3 Jan 2023.