Type 1 Diabetes Mellitus
Conditions
Keywords
Hypoglycemia, physical activity, heart rate
Brief 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.
Detailed description
Fear of hypoglycemia (FoH) is a specific fear caused by the risk and/or occurrence of hypoglycemia, and is associated with the frequency of severe hypoglycemic episodes, particularly during the past 3 months. FoH is a major barrier to physical activity and exercise in children and adolescents in T1DM. . Hypoglycaemic stress provides an ideal model with which to examine the interactions and consequences of physiological stress on the autonomic nervous system (ANS). Acute hypoglycaemia has been shown to increase inflammatory markers and impair cardiac-vagal baroreflex sensitivity, and exacerbate autonomic and cardiovascular dysregulation in adults with T1DM. Recurrent hypoglycemia can weaken autonomic responses and reduce awareness of hypoglycemia, which can increase FoH in individuals, leading to behavioral changes and impaired glycemic control. Therefore this study aims to investigate whether fear of hypoglycemia affects autonomic function, physical activity levels, and exercise capacity in children and adolescents with T1DM. 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. Incremental shuttle walking test will use to assess exercise capacity of participants.
Interventions
OTHERNo intervention (observational study)
No interventions; patient-reported, functional performance-based and HRV analysis.
Sponsors
Ordu University
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
10 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Autonomic Function | Baseline and immediately post-ISWT (Day 1) | Heart rate (HR), heart rate variability (HRV), blood pressure (BP), and peripheral oxygen saturation (SpO₂) will evaluate. Polar H10 chest-type HR sensor (Polar Electro Oy, Kempele, Finland) will use. The Polar H10 is a sensor that records R-R intervals based on electrocardiographic principles and provides data suitable for HRV analysis. The sensor was placed at heart level, at the sternum level, via a chest strap according to the manufacturer's instructions. The obtained data will transferred via Bluetooth connection to an iPhone 13 (Apple Inc., Cupertino, CA, USA) used as a mobile device and recorded via the Polar Flow application (© Polar Electro, 2024). HRV analyses will performed using Kubios HRV Standard software (version 3.5.0, Kubios Oy, Finland). |
| Physical Activity Questionnaire for Older Children (PAQ-C) | Baseline (Day 1) | Consisting of ten items and two sub-dimensions, nine of these are used to calculate the physical activity score. The tenth item assesses whether the child has been unable to perform their normal activities due to illness or disability in the last week. The total score is obtained by calculating the average of the scores from the first 9 items, with an average close to 1 indicating a low level of physical activity and an average close to 5 indicating a high level. The first sub-dimension of the questionnaire includes items 1, 5, 6, 7, 8, and 9, which cover physical activities performed "outside of school," while the second sub-dimension includes items 2, 3, and 4, which cover physical activities performed "inside of school." |
| Physical Activity Questionnaire for Adolescents (PAQ-A) | Baseline | It consists of nine items, the first eight of which are scored on a five-point Likert scale. The ninth item asks whether normal activities were performed in the last week due to illness or another reason, and it is not included in the total score calculation. The total score is obtained by calculating the average of the first eight items' scores, with an average close to 1 indicating a low level of physical activity and an average close to 5 indicating a high level. |
| Incremental shuttle walking test (ISWT) | Baseline (day 1) | ISWT will use to assess exercise capacity of participants. Two cones will used on a flat, non-slip surface, 9 m apart in this test. The course is calculated as 10 m, assuming a 50 cm turning distance around the cones. Participants are asked to walk back and forth between the two cones, following signals from a pre-recorded standard audio file. The test will start with the first tempo signal given after three preparatory signals. Participants must be at the opposite cone each time an audio signal is given. The starting walking speed in the test is 0.50 m/s, and the speed is increased by 0.17 m/s every minute. The protocol consists of a total of 12 levels, each representing one-minute increments. Each 10 m walk is considered a shuttle, and the total walking distance is calculated by the number of shuttles completed. |
Countries
Turkey (Türkiye)
Contacts
CONTACTSEMİHA YENİŞEHİR, Assist. Prof. Dr
Outcome results
None listed