Sleep1child: The Importance of Sleep for Diabetes Associated Tasks and Outcomes

Sponsor

Steno Diabetes Center Copenhagen (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05762783

Collaborator

Danish Diabetes Academy (Other), Danish Center for Sleep Medicine (Other), University of Copenhagen (Other), Herlev Hospital (Other)

300

Enrollment

17.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Adolescents with type 1 diabetes (T1D) experience more disturbed sleep and there is some evidence that they spend less time in deep sleep compared to their healthy peers, potentially impacting diabetes management. Disturbed sleep may adversely affect diabetes management which requires day-to-day decision-making, emotional and behavioural regulation, attention, and planning. Despite a massive increase in new technology, more than 50% of adolescents do not reach their glycaemic target. Lack of sleep impairing diabetes management including blood glucose monitoring may play an important role in reaching the goal. For approximately 4000 children and adolescents in Denmark living with T1D, sleep problems may therefore account for short and long-term diabetes complications.

We aim to cover the prevalence of disturbed sleep, in families with a child with T1D, and its association with diabetes management in children and adolescents using continuous glucose monitor (CGM).

Condition or Disease	Intervention/Treatment	Phase
type1diabetes Sleep Disturbance

Detailed Description

Background: Adolescents with type 1 diabetes (T1D) experience more disturbed sleep compared to their healthy peers, and there is some evidence that they spend less time in deep sleep, which is the most restoring part of sleep. Disturbed sleep may adversely affect diabetes management that requires day-to-day decision-making, emotional and behavioural regulation, attention and planning (behavioural pathway). Diabetes management including blood glucose monitoring (BGM) plays an important role in reaching the glycaemic target. Currently, >50% of adolescents do not reach the glycaemic target. Furthermore, the disturbance of circadian rhythmicity may have metabolic consequences (metabolic pathway). For the approximately 4000 children and adolescents in Denmark living with T1D, this means sleep problems may contribute negatively and increase the risk of short and long-term diabetes complications. The use of technology in T1D treatment has increased dramatically, but without a clear sign of improved glycaemic control. This may, in part, be explained by additional disturbances from alarms and difficulties in initiating sleep due to itching or irritation from having devices attached to the body. Disturbed sleep may contribute to the 40% increased risk of psychiatric disease associated with childhood diabetes.

We aim to cover the prevalence of disturbed sleep, in families with a child with T1D, and its association with diabetes management in children and adolescents using continuous glucose monitor (CGM).

Study design: Observational, cross-sectional study. Methods: Children and adolescents with type 1 diabetes (T1D) and one or both parents are recruited from the Diabetes Children Outpatient Clinic, Steno Diabetes Centre Copenhagen. We aim to recruit 200 families with a child with type 1 diabetes. Children and adolescents will complete the newly developed sleep questionnaire Scandinavian Sleep Questionnaire-Children and Adolescents (SSQ-CA) and parents the Pittsburgh Sleep Quality Index (PSQI). Questionnaires with topics associated with sleep will also be completed; Well-being (WHO-5), strengths and difficulties (SDQ-Dan), resilience (CYRM 12, only children ≥ 10 years old) (CD-RISC 10, parents), fear of hypoglycemia (CHI, only children ≥ 10 years old and parents) and stress (PSS, only parents). Objectively sleep will be measured with the actigraph wGT3x including fulfilment of a sleep diary for 7 days and nights and by the home sleep test REM+ (HSTR) for 5 nights in both children and parents. Data from the insulin pump and CGM will be collected.

Eligibility criteria: Participants are included if they are 6-17 years of age, have had T1D for > 6 months and use both insulin pump and CGM. Exclusion criteria are severe psychiatric diseases using ICD-10 codes (e.g. ADHD, autism spectrum disorder, eating disorders, retarded mental development), unwillingness to participate and inability to read and understand Danish or English.

Outcome: This study will determine the prevalence of disturbed sleep (% of the time in different sleep stages, total sleep time, sleep latency, sleep efficiency, wake after sleep onset) in our population and its association with a) glycemic outcomes (mean glucose and variability from the last 2 weeks sensor download); b) diabetes management (use of bolus-guide including blood glucose and carbohydrate from pump download); c) diabetes-specific stressors e.g. alarms and fear of hypoglycemia; d) general stress; and e) resilience.

Power/statistics: To detect a correlation above 0.3 between sleep duration and HbA1c, we have a power of 78% if 80 participate in the screening. With just 27 individuals we will be able to show a difference in resilience score of 4 (the difference found between adolescents below or above 58 mmol/mol in HbA1c) with a power of 81% and a significance level of 5%. Statistical methods will include T-test, Spearman's correlation, RASCH modelling of questionnaire data and regression models depending on the distribution. Inverse probability weighting will be used to examine selection bias due to non-participation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

The Importance of Sleep for Diabetes Associated Tasks and Outcomes

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Outcome Measures

Primary Outcome Measures

Sleep architecture [In the the study periode (one to maksimum five nights)]
% of total sleep time in different sleep stages
Total sleep time [In the study periode (one to maksimum seven nights)]
Time from sleep onset to wake-up time (minus awakenings)
Time-in/below/above range during daytime [The last 14 days of the study periode]
The % of the time in/below/above a specific blood glucose range

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 1 diabetes for > 6 months
Use of both insulin pump and continuous glucose monitor

Exclusion Criteria:

Severe psychiatric diseases using ICD-10 codes (e.g. ADHD, autism spectrum disorder, eating disorders, retarded mental development)
Unwillingness to participate and inability to read and understand Danish or English.