Clinical Trials Directory

Trials / Completed

CompletedNCT00848822

Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
University of Arizona · Academic / Other
Sex
All
Age
10 Years – 16 Years
Healthy volunteers
Not accepted

Summary

The purpose of this project is to look at how sleep affects glucose values in children with Type 1 Diabetes Mellitus. It will also evaluate if glucose is affected by times of day due to the body's own internal rhythm also known as the circadian rhythm.

Detailed description

Diabetes Mellitus (DM) is one of the most prevalent chronic pediatric diseases, affecting 2.80 cases per 1000 youth between the ages of 10 and 19. Since the crux of diabetes management is glucose regulation, any further challenges such as stress and/or poor sleep may make glucose regulation even more difficult. Mounting evidence supports the association between inadequate sleep and obesity as well as metabolic syndrome. Despite emerging findings supporting that total sleep time (TST) may contribute to the risk of obesity and/or metabolic complications, less research has been focused on Type 1 Diabetes Mellitus (T1DM) and on other sleep parameters. Participants will have a Continuous Glucose Monitor (CGM) and actigraph placed which they will wear for 5 days. At the end of the 5 days, they will return the glucose meter, CGM, and actigraph to a clinic staff or research team member to download their data. They will provide us with a glucose log that contains the glucose levels obtained from a fingerstick capillary glucose meter. In this log, participants will also record their activities, meals, and insulin administered. They will also provide us with a sleep diary. In addition, participants will have the option for the child to undergo polysomnography (sleep study) for one night in their home or two nights in the sleep lab.

Conditions

Timeline

Start date
2009-02-01
Primary completion
2010-07-01
Completion
2010-07-01
First posted
2009-02-20
Last updated
2011-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00848822. Inclusion in this directory is not an endorsement.