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Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
University of Arizona
ClinicalTrials.gov Identifier:
NCT00848822
First received: February 18, 2009
Last updated: April 14, 2011
Last verified: April 2011

February 18, 2009
April 14, 2011
February 2009
July 2010   (final data collection date for primary outcome measure)
This study could help find if there are particular times of day or times during sleep that change glucose the most. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00848822 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus
Sleep and Glucose Regulation in Youth With Type 1 Diabetes Mellitus

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Pariticipants will be recruited from the Angel Clinic for Children with Diabetes and Endocrine Disorders which is part of University Medical Center in Tucson, Arizona

  • Type 1 Diabetes Mellitus
  • Sleep
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2010
July 2010   (final data collection date for primary outcome measure)

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
Both
10 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00848822
08-1108-01
No
Priti Patel, M.D., University of Arizona
University of Arizona
Not Provided
Principal Investigator: Priti G Patel, M.D. University of Arizona
Principal Investigator: Michelle Perfect, PhD Univeristy of Arizona
University of Arizona
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP