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).
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.
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.
- Conditions
- Type1diabetes, Sleep, Chronotype
- 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 group | Role | What they receive |
|---|---|---|
| Case group | Children and adolescents diagnosed with type 1 diabetes aged between 6 to 18 years Receives: Other: sleep, chronotype | |
| Control group | Children 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.
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
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)
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
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.
- First posted19 Mar 2024
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Patterns and Chronotype Among Children and Adolescents With Type 1 Diabetes Compared to Case-control Peers Without Diabetes
- ClinicalTrials.gov ID
- NCT06318611
- Acronym / sponsor ID
- 09.2022.575
- Conditions
- Type1diabetes, Sleep, Chronotype
- Keywords
- type 1 diabetes, chronotype, continuous glucose monitoring, glycemic variability, sleep health, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Marmara University
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 19 Mar 2024 (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.
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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: sleep, chronotypeChildren and adolescents diagnosed with type 1 diabetes aged between 6 to 18 years |
| Control group | – | Other: sleep, chronotypeChildren and adolescents without type 1 diabetes between the ages of 6 and 18. |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children and adolescents diagnosed with and without type 1 diabetes aged between 6 to 18 years
Key inclusion criteria (2 listed)
- Aged between 6 to 18 years
- Use of continuous glucose monitor system
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| sleep, chronotypeOur 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. | Other | Case group, Control group |
Primary outcome
Sleep health composite
Time frame: Prospective, up to 24 weeks
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.
Chronotype
Time frame: Prospective, up to 24 weeks
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.
2 secondary outcomes
Glycemic variability
Time frame: Prospective, up to 24 weeks
Glycemic control
Time frame: Prospective, up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 39789979Ipar 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.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 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.