Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318611
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2024-02-19
Brief Title:
Sleep Patterns and Chronotype in Children With and Without Type 1 Diabetes
Sponsor:
Koç University
Organization:
Koç University
Study Overview
Official Title:
Sleep Patterns and Chronotype Among Children and Adolescents With Type 1 Diabetes Compared to Case-control Peers Without Diabetes
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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 Childrens Chronotype Questionnaire will be used to determine the chronotype Sleepwake patterns were also assessed using sleep diaries Glycemic variability was assessed using continuous glucose monitoring CGM device parameters
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 Childrens Chronotype Questionnaire will be used to determine the chronotype Sleepwake 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 075 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 1never 2rarely 3sometimes 4often and 5always The total score ranges from 8 to 40 points with higher scores indicating more severe sleep disturbances Sleepwake 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 0001 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 mgdl for glycemic control 4 at 70 mgdl for hypoglycemia 1 at 54 mgdl for severe hypoglycemia 25 at 180 mgdl for hyperglycemia and 5 at 250 mgdl for severe hyperglycemia The hemoglobin A1c level is also used for glycemic control
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 1never 2rarely 3sometimes 4often and 5always The total score ranges from 8 to 40 points with higher scores indicating more severe sleep disturbances Sleepwake 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 0001 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 mgdl for glycemic control 4 at 70 mgdl for hypoglycemia 1 at 54 mgdl for severe hypoglycemia 25 at 180 mgdl for hyperglycemia and 5 at 250 mgdl for severe hyperglycemia The hemoglobin A1c level is also used for glycemic control
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None