Type 1 Diabetes MellitusHypoFear-T1DMNCT07527676
Hypoglycemia Fear Affect Autonomic Function, Physical Activity, and Exercise Capacity in Type I Diabetes
An observational study of Type 1 Diabetes Mellitus, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2026to 30 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents with diagnosed T1DM
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ordu University Training and Research Hospital
Ordu, Cumhuriyet, 49000
SEMİHA YENİŞEHİR, PhD, PT, +90 0(452) 226 52 00, ysehir.semiha8@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- No intervention (observational study)
- Keywords
- Hypoglycemia, physical activity, heart rate
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention (observational study)Other
No interventions; patient-reported, functional performance-based and HRV analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1)
Secondary outcomes (4)
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).
Measured: 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."
Measured: 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.
Measured: 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.
Measured: Baseline (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start2 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 67 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Semiha Yenişehir, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527676
- Sponsor's protocol ID
- 27/03/2026
- Acronym
- HypoFear-T1DM
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25260537Singh 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.
PubMed 1494764The University of Virginia Child/Teen Low Blood Sugar Survey: Turkish Validity and Reliability Study
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.
PubMed 30764593
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Fear of Hypoglycemia Affect Autonomic Function, Physical Activity, and Exercise Capacity in Children and Adolescents With Type I Diabetes?
- ClinicalTrials.gov ID
- NCT07527676
- Acronym / sponsor ID
- HypoFear-T1DM / 27/03/2026
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Hypoglycemia, physical activity, heart rate
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes Participants | – | Other: No intervention (observational study)Children and adolecants with Type 1DM participating in autonomic function, exercise capacity, and physical activity assessments. No intervention is applied beyond standard care. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents with diagnosed T1DM
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)No interventions; patient-reported, functional performance-based and HRV analysis. | Other | Type 1 Diabetes Participants |
Primary outcome
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.
4 secondary outcomes
Autonomic Function
Time frame: Baseline and immediately post-ISWT (Day 1)
Physical Activity Questionnaire for Older Children (PAQ-C)
Time frame: Baseline (Day 1)
Physical Activity Questionnaire for Adolescents (PAQ-A)
Time frame: Baseline
Incremental shuttle walking test (ISWT)
Time frame: Baseline (day 1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 25260537Limberg 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.
- Results publication: PubMed 1494764Singh 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.
- Results publicationThe University of Virginia Child/Teen Low Blood Sugar Survey: Turkish Validity and Reliability Study
- Results publication: PubMed 30764593Erdim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus, run by Ordu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SEMİHA YENİŞEHİR, Assist. Prof. Dr (+90 (452) 226 52 00, ysehir.semiha8@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The University of Virginia Child/Teen Low Blood Sugar Survey (C-LBSS) (time frame: Baseline (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527676, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.