Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes (HypoFear-T1DM)

April 9, 2026 updated by: Semiha Yenişehir, Ordu University

Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents With Type I Diabetes?

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Cumhuriyet
      • Ordu, Cumhuriyet, Turkey (Türkiye), 49000
        • Ordu University Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents with diagnosed T1DM

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 1 Diabetes Participants
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS)
Time Frame: 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.
Baseline (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Autonomic Function
Time Frame: 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).
Baseline and immediately post-ISWT (Day 1)
Physical Activity Questionnaire for Older Children (PAQ-C)
Time Frame: 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."
Baseline (Day 1)
Physical Activity Questionnaire for Adolescents (PAQ-A)
Time Frame: 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.
Baseline
Incremental shuttle walking test (ISWT)
Time Frame: 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.
Baseline (day 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ordu University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 2, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

April 5, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27/03/2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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