The Importance of Sleep for Diabetes Associated Tasks and Outcomes

NCT05762783 | Completed DMC

• 1 other identifier: T_023
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Adolescents with type 1 diabetes (T1D) experience more disturbed sleep compared to their healthy peers, especially because they tend to spend less time in deep sleep, the most restoring part of sleep, 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 disturbances may therefore account for short and long-term diabetes complications. Our overall aims are to investigate: (1) If and how glycaemic variability (GV) influences sleep quality and sleep stages and (2) if and how poor sleep quality influences time-in-range (TIR), time-above-range (TAR) and time-below-range (TBR) the following day.

Conditions

type1diabetes; Sleep Disturbance

Keywords

type 1 diabetes; children and adolescents; sleep; continuos glucose monitor; diabetes management; sleep disturbance

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  % of total sleep time in deep sleep (stage N3 and N4)

  In the the study periode (one to maksimum five nights)

• Daytime time-in-range (TIR)

  3,9-10 mmol/L

  In the study periode (7 days)

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children and adolescents with type 1 diabetes (T1D) 6 to 17 years old, which have had the disease for over 6 months and use both an insulin pump and a continuous glucose monitor. One or both parents and healthy siblings are also included, but this is not a demand.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead
• Danish Diabetes Academy: collaborator
• Danish Center for Sleep Medicine: collaborator
• University of Copenhagen: collaborator
• Herlev Hospital: collaborator

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

MeSH Terms

Conditions

Parasomnias; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jannet Svensson, Professor

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 10, 2023
• Study Start: March 27, 2023
• Primary Completion: April 16, 2024
• Study Completion: April 16, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

DK (1)