Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06318611 |
| Other study ID # |
09.2022.575 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 1, 2022 |
| Est. completion date |
May 1, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Koç University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
