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Type1diabetesNCT06318611

Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes

An observational study of Type1diabetes and Sleep, run by Koç University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
Type1diabetes, Sleep, Chronotype
What is being tested?
sleep, chronotype
How many people
168 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 1 May 2023
Phase
Observational
Are there results?
None posted in the registry

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 6 to 18 years
  • All sexes
  • Child, Adult

Study population: Children and adolescents diagnosed with and without type 1 diabetes aged between 6 to 18 years

Who may be able to join

  • Aged between 6 to 18 years
  • Use of continuous glucose monitor system

Who cannot join

  • Acute medical condition that can impact sleep (diabetic ketoacidosis, cold, influenza)
  • Diagnosed neurodevelopmental or behavioral conditions like autism spectrum disorder or Attention Deficit/Hyperactivity Disorder
  • Diagnosed sleep disorder (Obstructive Sleep Apnea)
  • Current use of medications that can impact sleep (diphenhydramine)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Necla İpar

    Istanbul, 34010

Other trials in Turkey (Türkiye)

About this study

Official title: Sleep Patterns and Chronotype Among Children and Adolescents With Type 1 Diabetes Compared to Case-control Peers Without Diabetes

Type 1 diabetes (T1D) is one of the most common chronic childhood diseases. Recent studies have highlighted the strong association between type 1 diabetes and sleep health problems. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Studies show that children with T1D sleep significantly less than their peers without diabetes, and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism.

This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.

Read more

The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. Sleep disturbance will be assessed using the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Level 2-Sleep Disturbance Scale Short Form, and the Children's Chronotype Questionnaire will be used to determine the chronotype. Sleep/wake patterns were also assessed using sleep diaries. Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters.

Read the detailed description

Type 1 diabetes (T1D) is one of the most common chronic diseases in childhood. The prevalence of T1D in Turkey is reported to be 0.75%. Recent studies draw attention to the close relationship between type 1 diabetes and sleep problems. It has been suggested that sleep duration is insufficient and sleep quality is impaired in patients with T1D. Sleep problems have been reported to include sleep onset, sleep maintenance, frequent nighttime awakenings, and daytime sleepiness. Conditions such as nocturnal glycemic variability and fear of hypoglycemia specific to patients with T1D, alarms from devices such as continuous glucose monitors and pumps used in diabetes management, anxiety, stress and depressive symptoms associated with diabetes, and treatment that may sometimes last throughout the night are possible factors that adversely affect the sleep health of people with diabetes. Studies show that children with T1D sleep significantly less than their peers without diabetes and that this is associated with poorer glycemic control in type 1 diabetes due to impaired glucose metabolism. The American Diabetes Association (ADA) has emphasized that sleep health should be included in the routine assessment of people with diabetes by 2022.

This study aimed to compare sleep health composite dimensions and chronotype in children and adolescents with and without T1D, and to explore the relationship between sleep and glycemic variability in T1D.

The study was designed as a prospective observational case-control study. The estimated sample size is calculated as 168.

The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Each dimension is assigned a code of '1' for 'good' and '0' for 'poor.' The sleep health composite is designed so that a higher score indicates better overall sleep health.

Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents, within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances. Sleep/wake patterns were also assessed using sleep diaries.

The Childhood Chronotype Questionnaire was used to evaluate the chronotype in children. This 27-item questionnaire was developed for Turkish children in the light of the Munich Chronotype Questionnaire and the Mornings-Evenings Questionnaire. The chronotypes were classified as morning, intermediate and evening types, corresponding scores of ≤23, 24-32 and ≥33. The child form of the Childhood Chronotype Questionnaire was completed by the parent and the adolescent form was completed by the adolescent.

Glycemic variability was assessed using continuous glucose monitoring (CGM) device parameters. Glycemic variability was evaluated using the J index to assess the effectiveness of glycemic control (calculated as 0.001 × (mean + SD)), the low blood glucose index (LBGI) to evaluate the risk of hypoglycemia, the high blood glucose index (HBGI) to determine the likelihood of hyperglycemia, and the Coefficient of Variation (CV). The Coefficient of Variation expresses the percentage variation in blood glucose levels, with a CV ≤36% indicating a stable glucose profile and a CV >36% indicating an unstable glucose profile. For 24-hour continuous glucose monitoring, the targeted percentages of time were >70% at 70-180 mg/dl for glycemic control, <4% at <70 mg/dl for hypoglycemia, <1% at <54 mg/dl for severe hypoglycemia, <25% at >180 mg/dl for hyperglycemia and <5% at >250 mg/dl for severe hyperglycemia. The hemoglobin A1c level is also used for glycemic control.

Being tested
sleep, chronotype
Keywords
type 1 diabetes, chronotype, continuous glucose monitoring, glycemic variability, sleep health, sleep
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sleep, chronotypeOther

    Our objectives were to compare sleep health composite dimensions, and chronotype in children and adolescents with and without T1D, and to explore relationship between sleep and glycemic variability in T1D.

Study groups in NCT06318611
Study groupRoleWhat they receive
Case groupChildren and adolescents diagnosed with type 1 diabetes aged between 6 to 18 years
Receives: Other: sleep, chronotype
Control groupChildren and adolescents without type 1 diabetes between the ages of 6 and 18.
Receives: Other: sleep, chronotype

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep health composite

    The sleep health composite dimensions were measured using actigraphy, sleep diaries, and self- or parental reports. This composite evaluates various dimensions of sleep, including regularity, satisfaction, alertness, timing, efficiency, and duration. Sleep disturbances were assessed using the DSM-5 Level 2-Sleep Disturbance Scale Short Form. The DSM-5 Level 2-Sleep Disorders Scale short form was used to evaluate sleep disturbances. It is an 8-item scale that specifically evaluates sleep disorders in children and adolescents within the past 7 days. Each item is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often, and 5=always). The total score ranges from 8 to 40 points, with higher scores indicating more severe sleep disturbances.

    Measured: Prospective, up to 24 weeks

  2. Chronotype

    Chronotype was evaluated by the Children's Chronotype Questionnaire. The Childhood Chronotype Questionnaire was used to evaluate the chronotype in children. This 27-item questionnaire was developed for Turkish children in the light of the Munich Chronotype Questionnaire and the Mornings-Evenings Questionnaire. The chronotypes were classified as morning, intermediate and evening types, corresponding scores of ≤23, 24-32 and ≥33. The child form of the Childhood Chronotype Questionnaire was completed by the parent and the adolescent form was completed by the adolescent.

    Measured: Prospective, up to 24 weeks

Secondary outcomes (2)
  1. Glycemic variability

    Glycemic variability was assessed using continuous glucose monitoring device parameters. Glycemic variability was evaluated using the J index to assess the effectiveness of glycemic control, the low blood glucose index (LBGI) to evaluate the risk of hypoglycemia, the high blood glucose index (HBGI) to determine the likelihood of hyperglycemia, and the Coefficient of Variation.

    Measured: Prospective, up to 24 weeks

  2. Glycemic control

    For 24-hour continuous glucose monitoring, the targeted percentages of time were >70% at 70-180 mg/dl for glycemic control, <4% at <70 mg/dl for hypoglycemia, <1% at <54 mg/dl for severe hypoglycemia, <25% at >180 mg/dl for hyperglycemia and <5% at >250 mg/dl for severe hyperglycemia. The hemoglobin A1c level is also used for glycemic control.

    Measured: Prospective, up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2024
  2. Study start1 May 2022
  3. Primary completion1 May 2023
  4. Study completion1 May 2023

Resources

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
Case-control
Time perspective
Prospective
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06318611
Sponsor's protocol ID
09.2022.575
Status last verified
Feb 2024
First submitted
19 Feb 2024
Last updated
19 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ipar N, Boran P, Baris HE, Us MC, Aygun B, Haliloglu B, Baygul A, Mutlu GY, Bereket A, Hatun S. The sleep health composite and chronotype among children and adolescents with type 1 diabetes compared to case-control peers without diabetes. J Clin Sleep Med. 2025 May 1;21(5):825-834. doi: 10.5664/jcsm.11558.

    PubMed 39789979

Questions about this trial

What is this clinical trial studying?

An observational study of Type1diabetes and Sleep, run by Koç 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Mar 2024. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep health composite (time frame: Prospective, up to 24 weeks). The study lists 2 primary outcomes in all. 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 NCT06318611, which also lists 1 linked publication.

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 19 Mar 2024.

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