Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes

NCT07527676 | Not Yet Recruiting

• 1 other identifier: 27/03/2026
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Hypoglycemia; physical activity; heart rate

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 1)

Secondary Outcomes (4)

• Autonomic Function

  Baseline and immediately post-ISWT (Day 1)

• Physical Activity Questionnaire for Older Children (PAQ-C)

  Baseline (Day 1)

• Physical Activity Questionnaire for Adolescents (PAQ-A)

  Baseline

• Incremental shuttle walking test (ISWT)

  Baseline (day 1)

Study Arms (1)

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)

Interventions

No intervention (observational study) OTHER

No interventions; patient-reported, functional performance-based and HRV analysis.

Type 1 Diabetes Participants

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with diagnosed T1DM

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ordu University: lead

Study Sites (1)

Ordu University Training and Research Hospital

Ordu, Cumhuriyet, 49000, Turkey (Türkiye)

Location

Related Publications (4)

• Limberg JK, Farni KE, Taylor JL, Dube S, Basu A, Basu R, Wehrwein EA, Joyner MJ. Autonomic control during acute hypoglycemia in type 1 diabetes mellitus. Clin Auton Res. 2014 Dec;24(6):275-83. doi: 10.1007/s10286-014-0253-y. Epub 2014 Sep 27.

  PMID: 25260537 RESULT

• Singh SJ, Morgan MD, Scott S, Walters D, Hardman AE. Development of a shuttle walking test of disability in patients with chronic airways obstruction. Thorax. 1992 Dec;47(12):1019-24. doi: 10.1136/thx.47.12.1019.

  PMID: 1494764 RESULT

• The University of Virginia Child/Teen Low Blood Sugar Survey: Turkish Validity and Reliability Study

  RESULT

• Erdim L, Ergun A, Kuguoglu S. Reliability and validity of the Turkish version of the Physical Activity Questionnaire for Older Children (PAQ-C). Turk J Med Sci. 2019 Feb 11;49(1):162-169. doi: 10.3906/sag-1806-212.

  PMID: 30764593 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia; Motor Activity

Interventions

Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

SEMİHA YENİŞEHİR, Assist. Prof. Dr

CONTACT

+90 (452) 226 52 00; ysehir.semiha8@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2026
• First Posted: April 14, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)