Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

Completed

• Conditions: Sleep; Type 1 Diabetes Mellitus

• Registration Number: NCT00848822
• Lead Sponsor: University of Arizona

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-19
• Study First Posted: 2009-02-20
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-04
• Last Update Submitted: 2011-04-14
• Last Update Posted: 2011-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Type I Diabetes Mellitus
• Age of 10-16 year old

Exclusion Criteria

• Significant Developmental Delay
• Any other condition that in the opinion of the medical treatment team would interfere with his/her ability to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
This study could help find if there are particular times of day or times during sleep that change glucose the most.	12 months

Secondary Outcome Measures

Name	Time	Method
This study may help make recommendations about the best time to test glucose values and better help children with Type 1 Diabetes Mellitus control their glucose levels.	12 months

Trial Locations

Locations (1)

Steele Research Memorial Foundation, Angel Clinic for Children with Diabetes and Endocrine Disorders; 🇺🇸 Tucson, Arizona, United States