An observational study in Type 1 Diabetes Mellitus, sponsored by Ordu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Ordu University · Observational
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.
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 67 is below the median of 125 across 792 observational studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Ordu University is the lead sponsor of 32 studies on the registry; 12 are open to participants now.
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Children and adolescents with diagnosed T1DM
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children and adolecants with Type 1DM participating in autonomic function, exercise capacity, and physical activity assessments. No intervention is applied beyond standard care.
Other: No intervention (observational study)
No interventions; patient-reported, functional performance-based and HRV analysis.
The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS)
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.
Time frame: Baseline (Day 1)
Autonomic Function
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).
Time frame: Baseline and immediately post-ISWT (Day 1)
Physical Activity Questionnaire for Older Children (PAQ-C)
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."
Time frame: Baseline (Day 1)
Physical Activity Questionnaire for Adolescents (PAQ-A)
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.
Time frame: Baseline
Incremental shuttle walking test (ISWT)
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.
Time frame: Baseline (day 1)
Plan to share: No
Start is estimated for May 2026; primary completion for Jun 2026, 1 month later.
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