- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05666791
The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Study Overview
Status
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Hsin-Yi Wang, master's student
- Phone Number: 261057 +8862 2312-3456
- Email: hsinyiwang@ntuh.gov.tw
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Participants diagnosed with cognitive or mental health problems were excluded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 minutes
|
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.
|
5 minutes
|
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.
|
10 minutes
|
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.
|
10 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202210117RINC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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