No intervention (observational study): No interventions; patient-reported, functional performance-based and HRV analysis.
Study summary
This cross-sectional study aims to investigate whether fear of hypoglycemia affects autonomic function, physical activity levels, and exercise capacity in children and adolescents with T1DM.
The main question it aims to answer is:
Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents with Type I Diabetes? Participants will answer questionnaires about fear of Hypoglycemia and physical activity. Heart rate (HR), heart rate variability (HRV), blood pressure (BP), and peripheral oxygen saturation (SpO₂) will evaluate for autonomic function.
Eligibility
Sex
ALL
Min age
10 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria:
* being aged 10-18 years,
* having been diagnosed with T1DM at least one year ago,
* having an HbA1c of ≤7% in the last three months,
* being literate in Turkish,
* voluntarily participating in the study.
Exclusion Criteria:
* visual, auditory or cognitive problems that would prevent participation, orthopaedic or neurological problems (e.g. walking or running difficulties) that would prevent participation,
* BMI \<18.5 kg/m², any complications related to T1DM,
* being in the insulin/sensor dose adjustment/adjustment phase or having a history of diabetic ketoacidosis in the last month.
Primary outcome measure(s)
The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS) — Baseline (Day 1) C-LBSS was developed to assess FoH in children and adolescents. The Turkish version of C-LBSS with Cronbach's alpha of 0.843 and a test-retest correlation of 0.997 will used to assess FoH in this study. It consists of 25 items and includes two sub-dimensions measuring children's/adolescents' levels of hypoglycemia-related behaviors (items 1-10) and anxiety (items 11-25). Items are rated on a 5-point Likert scale (0 = "never" to 4 = "almost always"), and the total score on the scale ranges from 0 to 100, with an increase in the score indicating increased FoH.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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