Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.

Key facts

Study ID

NCT03397147

Run by

Vanderbilt University Medical Center

People needed

40

Starts

2018-07-05

Expected to finish

2019-07-09

Last updated by the study team

2020-03-26

Who can join

Age: 5 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• child between 5-9 years of age
• child have been diagnosed with type 1 diabetes for at least 12 months
• caregiver lives with child
• caregiver can read/speak English

You may not qualify if…

• child has other major health problems or sleep disorders other than insufficient sleep or insomnia
• participating in other intervention studies

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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